• National Collaborating Centre for Chronic Conditions. Chronic heart failure. National clinical guideline for diagnosis and management in primary and secondary care. London: National Institute for Clinical Excellence (NICE); 2003. 163 p. [347 references]

This is the current release of the guideline.

Chronic heart failure

Diagnosis
Evaluation
Management
Risk Assessment
Treatment

Cardiology
Family Practice
Geriatrics
Internal Medicine

Health Care Providers
Hospitals
Nurses
Patients
Physicians
Public Health Departments

• To offer best practice advice on the care of adult patients (aged 18 years or older) who have symptoms or a diagnosis of chronic heart failure
• To define the most effective combination of symptoms, signs, and investigations required to establish a diagnosis of heart failure and those which will influence therapy or provide important prognostic information
• To give guidance on the treatment, monitoring, and support of patients with heart failure

Adult patients (aged 18 years or older) who have symptoms or a diagnosis of chronic heart failure.

Note: The guideline does not cover "acute" heart failure but does include comment on exacerbation of the syndrome and the causes and treatment of this, recognising that chronic heart failure often has an undulating course. The guideline does not address the screening or diagnosis of people who are asymptomatic, nor does it address the management of patients with right heart failure as a consequence of respiratory disease.

Diagnosis/Monitoring

1. Evaluation of history, symptoms, and signs
2. 12-lead electrocardiography (ECG)
3. Chest x-ray
4. Biochemical markers, including natriuretic peptides (B-type natriuretic peptide or N-terminal pro-B-type natriuretic peptide)
5. Blood tests, including electrolytes, urea, and creatinine, full blood count, liver function tests, thyroid function tests, glucose, and lipids
6. Imaging techniques, including transthoracic or transoesophageal Doppler 2D echocardiography, radionuclide imaging, or cardiac magnetic resonance imaging
7. Urinalysis
8. Peak flow or spirometry
9. Assessment of functional capacity
10. Assessment of fluid status
11. Assessment of cardiac rhythm
12. Therapeutic drug monitoring of serum digoxin concentrations

Pharmacological Treatments

1. Angiotensin-converting enzyme (ACE) inhibitors
2. Angiotensin-II receptor antagonists
3. Beta-blockers
4. Digoxin
5. Diuretics, including loop diuretics, thiazides, potassium-sparing diuretics
6. Nitrates and other vasodilators
7. Spironolactone
8. Amiodarone
9. Anticoagulants
10. Aspirin
11. Statins
12. Isosorbide/hydralazine combinations
13. Inotropic agents
14. Calcium channel blockers

Non-pharmacological Treatments

1. Exercise programmes and rehabilitation
2. Provision of lifestyle advice on diet, physical activity, weight reduction, sexual activity, alcohol use and smoking cessation, air travel, and driving regulations
3. Vaccination (influenza, pneumococcal)

Invasive Procedures

1. Coronary revascularisation
2. Cardiac transplant
3. Cardiac resynchronisation therapy
4. Implantable cardioverter-defibrillators (ICDs)

General Management Principles

1. Providing referral for more specialist advice
2. Discharge planning
3. Providing a multidisciplinary team approach to heart failure management
4. Providing support to patients and carers through effective communication, prognosis discussion, and referral to local support groups
5. Diagnosing and treating anxiety and depression
6. Providing information on end of life issues

• Quality of life
• Life expectancy
• Mortality
• Exercise capacity
• Signs and symptoms
• Hospitalisation rates
• Predictive value of tests
• Sensitivity and specificity of diagnostic tests
• Renal function
• Cost-effectiveness

Searches of Electronic Databases

Searching for the Evidence

There are three stages to evidence identification and retrieval:

1. The technical team set out a series of specific clinical questions (see Appendix A of the full guideline document) that covered the issues identified in the project scope. The consensus/reference group (CRG) met to discuss, refine, and approve these questions as suitable for identifying appropriate evidence within the published literature.
2. The information scientist developed a search strategy for each question to identify the available evidence. Identified titles and abstracts were reviewed for relevance to the agreed clinical questions and full papers obtained as appropriate. Full papers were assessed for inclusion according to predefined criteria (see Appendix B of the full guideline document).
3. The full papers were critically appraised and the pertinent data entered into evidence tables that were then reviewed and analysed by the guideline development group (GDG) as the basis upon which to formulate recommendations.

Limited details of the searches with regard to databases and constraints applied can be found in Appendix B of the full guideline document. Grey literature was searched for using the System for Information on Grey Literature in Europe (SIGLE). No formal contact was made with authors of identified studies. Additional contemporary articles were identified by the GDG on an ad hoc basis. Stakeholder evidence identified via a process established by the National Institute for Clinical Excellence (NICE) was incorporated where appropriate and was assessed for inclusion by the same criteria as evidence provided by the electronic searches.

Searches were re-run at the end of the guideline development process, thus including evidence published up to the end of September 2002. Studies recommended by stakeholders or GDG members that were published after this date were not considered for inclusion. This time-point should be the starting point for searching for new evidence for future updates to this guideline.

Health Economics Evidence

While evidence on cost effectiveness was extracted from the main searches wherever it existed, this was rare; hence it was necessary to undertake a separate search for information on the potential costs and benefits of the interventions and management strategies considered in this guideline. The information scientist carried out these searches with guidance on search terms from the health economist. The GDG realised that few formal cost effectiveness analyses would be identified, therefore the search for economic evidence was very broad and designed to identify information about the resources used in providing a service or intervention and/or the benefits that can be attributed to it. No study design criteria were imposed a priori (i.e., the searches were not limited to randomized controlled trials or formal economic evaluations). Further details of the searches for economic evidence are given in Appendix C of the full guideline document.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Evidence Categories

Ia: Evidence obtained from systematic review of meta-analysis of randomised controlled trials

Ib: Evidence obtained from at least one randomised controlled trial

IIa: Evidence obtained from at least one well-designed controlled study without randomisation

IIb: Evidence obtained from at least one other type of well-designed quasi-experimental study

III: Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies, and case studies

IV: Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities.

Systematic Review

Synthesising the Evidence

Abstracts of articles identified from the searches were screened for irrelevant items, and hard copies were ordered of papers that appeared to provide useful evidence relevant to each clinical question. Each paper was assessed for its methodological quality against pre-defined criteria using a validated evaluation tool. Papers that met the inclusion criteria were then assigned a level according to the evidence hierarchy as detailed in Section 3 of the full guideline document and in the section of this summary titled "Rating Scheme for the Strength of the Evidence." Owing to practical limitations, selection, critical appraisal, and data extraction were undertaken by one reviewer only. However evidence was considered carefully by the guideline development group (GDG) for accuracy and completeness.

Each clinical question dictated the appropriate study design that should be prioritised in the search strategy. In addition certain topics within any one clinical question at times required different evidence types to be considered. Randomised control trials (RCTs) were the most appropriate study design for a number of clinical questions as they lend themselves particularly well to research into medicines. They were not, however, the most appropriate study design for all clinical questions. For example, the evaluation of diagnostic tests is more suited to alternative research designs. Furthermore, RCTs are more difficult to perform in areas such as rehabilitation and lifestyle, where interventions may be tailored to the needs of the individual. As such, pharmaceutical interventions tend to be placed higher in the evidence hierarchy than other equally important interventions. This should not be interpreted as a preference for a particular type of intervention or as a reflection of the quality of the evidence, particularly for those clinical areas where non-RCT evidence is valid and most appropriate.

Where available, evidence from well-conducted systematic reviews was appraised and presented. Trials included within these reviews are listed in the evidence table but were not critically appraised. Studies identified in addition to those included in the systematic review were included in the appraisal process.

The study populations considered varied between clinical questions. At times evidence was not available from studies that included a heart failure population; therefore it was necessary to consider studies in other chronic conditions. Where this occurred it is indicated in the relevant evidence statement.

Study quality, although formally assessed, was not used as a basis for informing the evidence level assigned to evidence statements. Descriptive limitations of studies are, however, included in the statements as appropriate. On occasion the GDG identified a clinical question that could not be appropriately answered through undertaking a systematic review (where the evidence was scarce, or where the question could not usefully be answered with the largely dichotomous output of a review). These questions were addressed via an expert-drafted discussion paper, subject to consideration by the GDG. In these instances there was no formal search strategy used by the clinical expert or assessment of the studies cited. These review papers were developed and used as a basis for discussion by the GDG as a whole.

Finally, national and international evidence based guidelines were referred to during the development process. These were not formally appraised owing to the inherent difficulties of such a process, in that the consistency of process and of evidence base can be difficult to ascertain across such documents.

Expert Consensus (Nominal Group Technique)

The Developers

Two multiprofessional groups, supported by a technical team from the National Collaborating Centre for Chronic Conditions (NCC-CC), were involved in the development of the guideline:

• A small guideline development group (GDG) that met monthly for twelve months and undertook the detailed evidence assessment and recommendation drafting
• An extension of the GDG, the larger consensus/reference group (CRG), which met twice throughout the process: once early in the development to ensure the clinical questions and aims were appropriate, and again at the end of the process to review the recommendations drafted by the GDG. The group employed formal consensus techniques in their consideration of clinically important areas where there was insufficient evidence.

Nominations for group members were invited from various stakeholder organisations, which were selected to ensure an appropriate mix of clinical professions and patient groups. Group membership details can be found on pp iii–iv of the full guideline document.

Involvement of Patients with Heart Failure

As part of the development process, the NCC-CC was keen to ensure that the guideline development process was informed by the views of patients with heart failure and their carers. This was achieved in two ways:

• By securing patient organisation representation on the guideline development group
• By carrying out a focus group to ensure that the views of people directly affected by heart failure informed the development of the guideline.

Patient representatives from the Cardiomyopathy Association and the British Heart Foundation were members of the GDG. They were therefore involved at every stage of the guideline development process and were able to consult with their wider constituencies throughout the process.

Drafting the Recommendations

Evidence for each topic was extracted into tables and summarised in evidence statements. The GDG reviewed the evidence tables and statements at each meeting and reached a group opinion. Recommendations were explicitly linked to the evidence supporting them and graded according to the level of the evidence upon which they were based, using the grading system detailed in Section 3 of the full guideline document and in the section of this summary titled "Rating Scheme for the Strength of the Recommendations." It should be noted that the level of evidence determines the grade assigned to each recommendation and as such does not necessarily reflect the importance attached to the recommendation.

Agreeing the Recommendations

Once the evidence review had been completed and an early draft of the guideline produced, a one-day meeting of the CRG was held to finalise the recommendations. This included a premeeting vote on the recommendations and a further vote at the CRG meeting, where the groups were asked to consider the draft guideline in two stages.

1. Are the evidence-based statements acceptable and is the evidence cited sufficient to justify the grading attached?
2. Are the recommendations derived from the evidence justified and are they sufficiently practical so that those at the clinical front line can implement them prospectively? There were three types of recommendation to be considered:
   • A recommendation from the GDG based on strong evidence – usually non-controversial unless there was important evidence that had been missed or misinterpreted
   • A recommendation that was based on good evidence but where it was necessary to extrapolate the findings to make it useful in the National Health Society (NHS) – the extrapolation approved by consensus
   • Recommendations for which no evidence exists but which address important aspects of heart failure care or management – and for which a consensus on best practice could be reached

This formal consensus method has been established within the NCC-CC, drawing on the knowledge set out in the health technology appraisal, and practical experience. It approximates to a modification of the RAND Nominal Group Process and will be fully described in future publications.

Writing the Guideline

The guideline was drawn up by the technical team in accordance with the decisions of the guideline groups.

Typical Grading of Recommendations

A: At least one randomised controlled trial as part of a body of literature of overall good quality and consistency addressing the specific recommendation (evidence levels Ia and Ib)

B: Well-conducted clinical studies but no randomised clinical trials on the topic of recommendation (evidence levels IIa, IIb, and III)

C: Expert committee reports or opinions and/or clinical experience of respected authorities. This grading indicates that directly applicable clinical studies or good quality are absent (evidence level IV).

GPP: Recommended good practice based on the clinical experience of the Guideline Development Group

DS: Diagnostic studies

NICE: Evidence from the National Institute for Clinical Excellence (NICE) guidelines or health technology appraisal programme.

Identified titles and abstracts from the economics searches were reviewed by the health economist and full papers obtained as appropriate. The full papers were critically appraised by the health economist and the relevant data was conveyed to the Guideline Development Group alongside the clinical evidence for each question. Given that the economics searches were so broad and that no standard measure of assessing the quality of economic evidence is available, careful consideration was given to each study design and the applicability of the results to the guideline context. An important issue in this respect is that much of the evidence on costs and benefits comes from the healthcare system in the United States and is therefore of limited applicability to a United Kingdom guideline.

As well as presenting existing evidence on the costs and benefits of a broad range of interventions to the Guideline Development Group, the issue of echocardiography in the diagnosis of heart failure was identified as an important area for further economic analysis. This choice was made on the grounds that the diagnostic procedure may be associated with:

• Potentially large health benefits
• A potentially large effect on National Health Service resources
• Uncertainty surrounding the benefits and resources
• A potentially large service impact

While health economic analysis can provide a framework for collating information from a variety of sources in order to estimate and systematically compare costs and benefits, this is a complex and labour-intensive process, and it does require a level of clinical evidence that is not always readily available. As a result the cost effectiveness of echocardiography in the diagnosis of heart failure was the only issue prioritised for further analysis. The results of this analysis are discussed briefly in section 6.1 of the full guideline document, with further detail in Appendix G of the full guideline document.

External Peer Review
Internal Peer Review

The draft guideline was circulated to stakeholders according to the formal National Institute for Clinical Excellence (NICE) stakeholder consultation and validation phase prior to publication, and modifications, agreed by the Guideline Development Group, were made as a result.

Algorithms are provided in the original guideline document for the summarisation of recommendations for the diagnosis of heart failure and for the pharmacological treatment of symptomatic heart failure due to left ventricular (LV) systolic dysfunction.

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

A more equitable and evidence-based approach to the diagnosis and treatment of heart failure in adults in England and Wales

Refer to the full version of the original guideline document for information on possible side effects of medications.

• Beta-blockers are contraindicated in patients with reversible airways disease.
• Absolute contraindications to the use of angiotensin-converting enzyme (ACE) inhibitors include a history of anuria or angioedema with past exposure to the drug, bilateral renal artery stenosis, pregnancy, and cardiogenic shock. Hypotension is not necessarily a contraindication, but consultation with a specialist is advised before use in a patient with a systolic blood pressure less than 80 mmHg.
• ACE inhibitors and angiotensin-II receptor antagonists may be contraindicated in patients with renal dysfunction (e.g., serum creatinine >200 micromoles/litre). Patient requires specialist assessment.
• Peripheral vascular disease may be an absolute contraindication to beta-blocker ACE inhibitor therapy where there is a high index of suspicion for renal artery stenosis.
• Verapamil, diltiazem, or short-acting dihydropyridine agents should be avoided for treatment of comorbid hypertension and/or angina in patients with heart failure.

This guidance is written in the following context: This guidance represents the view of the Guideline Development Group and the National Institute for Clinical Excellence, which was arrived at after careful consideration of the evidence available. Health professionals in the National Health Service in England and Wales are expected to take it fully into account when exercising their clinical judgment. The guidance does not, however, override the individual responsibility of health professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

It should be noted that the level of evidence determines the grade assigned to each recommendation and as such does not necessarily reflect the importance attached to the recommendation.

Guideline Limitations

The document and recommendations are subject to various limitations. The sponsoring authority, the National Institute for Clinical Excellence (NICE), is concerned primarily with health services, and so these recommendations only indirectly refer to social services, the voluntary sector, and post-transplant care. Nonetheless, the importance of other agencies cannot be overstated and in each locality the aim should be to integrate heart failure care across all relevant sectors.

A systematic approach was used to locate and appraise the evidence and explicit inclusion criteria were applied. Due to the magnitude of the literature potentially relevant to heart failure, the inclusion criteria aimed to limit the included studies to those of a higher quality conducted primarily in patients with heart failure. Where these were not available, well-conducted studies outside heart failure, or lower level studies in patients with heart failure, were included.

Unpublished Trials

The developers have referred in the text to all key ongoing trials which the developers were aware were going to publish within months of the cut-off date for literature searches, and which, in the opinion of the guideline development group, could conceivably impact on the guideline. This is intended to help the reader in using the guideline in the near future. The findings of such trials did not influence the formulation of recommendations in any way.

Implementation in the National Health Service

Local health communities should review their existing service provision for the management of heart failure against this guideline as they develop their Local Delivery Plans. The review should consider the resources required to implement fully the recommendations detailed below and in Section 1 of the original guideline document, the people and processes involved, and the timeline over which full implementation is envisaged. It is in the interests of patients that the implementation timeline is as rapid as possible.

Relevant local clinical guidelines and protocols should be reviewed in the light of this guidance and revised accordingly.

Suggested audit criteria are listed in Appendix E of the original guideline document.

The following recommendations have been identified as priorities for implementation.

Diagnosis

• The basis for historical diagnoses of heart failure should be reviewed, and only patients whose diagnosis is confirmed should be managed in accordance with this guideline.
• Doppler 2D echocardiographic examination should be performed to exclude important valve disease, assess the systolic (and diastolic) function of the (left) ventricle, and detect intracardiac shunts.

Treatment

• All patients with heart failure due to left ventricular systolic dysfunction should be considered for treatment with an angiotensin-converting enzyme (ACE) inhibitor.
• Beta-blockers licensed for use in heart failure should be initiated in patients with heart failure due to left ventricular systolic dysfunction after diuretic and ACE inhibitor therapy (regardless of whether or not symptoms persist).

Monitoring

• All patients with chronic heart failure require monitoring. This monitoring should include:
  • A clinical assessment of functional capacity, fluid status, cardiac rhythm, and cognitive and nutritional status
  • A review of medication, including need for changes and possible side effects
  • Serum urea, electrolytes, and creatinine

Discharge

• Patients with heart failure should generally be discharged from hospital only when their clinical condition is stable and the management plan is optimised.
• The primary care team, patient, and carer must be aware of the management plan.

Supporting Patients and Carers

• Management of heart failure should be seen as a shared responsibility between patient and healthcare professional.

End of Life Care
Living with Illness

Effectiveness
Patient-centeredness

• National Collaborating Centre for Chronic Conditions. Chronic heart failure. National clinical guideline for diagnosis and management in primary and secondary care. London: National Institute for Clinical Excellence (NICE); 2003. 163 p. [347 references]

Not applicable: The guideline was not adapted from another source.

2003 Jul

National Collaborating Centre for Chronic Conditions - National Government Agency [Non-U.S.]

National Institute for Clinical Excellence (NICE)

Guideline Development Group (GDG)
Consensus Reference Group (CRG)

Guideline Development Group Members: Ms Audrey Alimo, Nurse Consultant for Heart Failure, Central Middlesex Hospital, London; Dr Graham Archard, General Practitioner, Christchurch; Mr Steven Barnes, Health Services Research Fellow in Guideline Development, National Collaborating Centre for Chronic Conditions; Professor Martin Cowie (Clinical Advisor) Professor of Cardiology, National Heart and Lung Institute, Imperial College, London; Ms Stephanie Cruickshank, Heart failure patient and carer representative; Cardiomyopathy Nurse Specialist, St George’s Hospital, London; Dr Perry Elliott, Senior Lecturer in Cardiology, St George’s Hospital Medical School, London; Professor Rose Anne Kenny, Professor of Geriatric Medicine, University of Newcastle; Dr Jonathan Mant (Lead) Senior Lecturer in Public Health, University of Birmingham; Mr Derrick Masters, Heart failure patient and carer representative; Dr Jennifer Roberts, Senior Lecturer in Health Economics, School of Health and Related Research, University of Sheffield; Professor Mojgan Sani, Consultant Pharmacist, Guys’ and St Thomas’ Hospital Trust and Visiting Professor, School of Pharmacy and Pharmacology, University of Bath; Ms Hasina Shaikh, Information scientist, National Collaborating Centre for Chronic Conditions; Dr Lip-Bun Tan, Consultant Cardiologist, Leeds General Infirmary; Dr Ann Taylor, Chartered Physiotherapist, School of Biomedical Sciences, King’s College London; Research Officer, Association of Chartered Physiotherapists in Cardiac Rehabilitation; Ms Sarah Williams, Project manager, National Collaborating Centre for Chronic Conditions

Consensus Reference Group (CRG) Members: Professor John Camm (Chair) President, British Cardiac Society; Professor of Cardiology, St George’s Hospital Medical School, London; Professor John Cleland, Professor of Academic Cardiology, University of Hull; Dr Michael Gammage, Consultant Physician in Cardiovascular Medicine, Queen Elizabeth Hospital, Birmingham; Dr Louise Gibbs*, Consultant Physician in Palliative Care, St Christopher’s Hospice, Surrey; Professor Richard Hobbs, Professor of General Practice, University of Birmingham; Ms Lee Hooper, Research Associate in Evidence-Based Care and Systematic Review, University Dental Hospital of Manchester; Dr Malcolm Metcalfe, Consultant Cardiologist, Aberdeen Royal Infirmary; Ms Chris Monaco, Cardiology Department, Calderdale Royal Hospital; Dr Kevin O'Shaughnessy*, University Lecturer in Clinical Pharmacology & Honorary Consultant Physician, Addenbrooke’s Hospital, Cambridge; Dr Chakravarthi Rajkumar*, Senior Lecturer and Consultant Physician, Care of the Elderly, Imperial College School of Medicine, London; Ms Sara Richards, Chair, Royal College of Nursing Practice Nurses’ Association; Nurse Practitioner, Slough NHS Walk-In Centre; Professor Jonathan Richards*, External Professor of Primary Care, University of Glamorgan; Dr David Roberts, Consultant Cardiologist, Victoria Hospital, Blackpool; Dr Chris Spencer-Jones, Director of Public Health, Dudley Health Authority

* Attended and contributed to at least one GDG meeting

All group members made a formal 'declaration of interests' at the start of the guideline development and provided updates throughout the process. The National Collaborating Centre for Chronic Conditions (NCC-CC) and the group leaders monitored these, and no conflicts were identified.

This is the current release of the guideline.

This NGC summary was completed by ECRI on July 14, 2004. The information was verified by the guideline developer on November 29, 2004. This summary was updated by ECRI Institute on November 6, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.