Serial BNP Measurements and Time to Disappearance of S3 in Goal-Directed Therapy of ADHF - Full Text View

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00514384

Purpose

To test the hypotheses that an early goal-directed decrement of preload and afterload with a target systolic blood pressure of 90-110 mmHg by aggressive vasodilatation in patients with acute HF in the non-ICU setting will leads to a favourable course of BNP levels and to a faster disappearance of S3.

Condition	Intervention
Acute Heart Failure	Drug: Early goal-directed therapy - Nitroglycerin Streuli®, Nitroderm TTS®, Triatec®, Atacand®

MedlinePlus related topics: Heart Failure

Drug Information available for: Candesartan cilexetil CV 11974 Ramipril Nitroglycerin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Course of BNP

Secondary Outcome Measures:

Time to disappearance of S3

Estimated Enrollment:	80
Study Start Date:	September 2007
Estimated Study Completion Date:	January 2008

Intervention Details:

An early goal-directed decrement of preload and afterload with a target systolic blood pressure of 90-110 mmHg by aggressive vasodilatation in patients with acute HF in the non-ICU setting using sublingual nitrates (Nitroglycerin Streuli®), transdermal nitrates (Nitroderm TTS®, ACE-inhibitors (Triatec®)and/or ARB (Atacand®).

Detailed Description:

Background: Heart failure (HF) is a chronic and progressive illness resulting from a variety of cardiac causes, including ischemic and valvular heart disease, dilatative cardiomyopathy or hypertension. HF may also develop suddenly, particularly as a complication of acute myocardial infarction or as an acute exacerbation in patients with previously compensated chronic HF. Acute HF requires immediate treatment that centers on reducing myocardial oxygen demand and augmenting forward blood flow by removal of excess fluid with diuretics and reduction of preload and afterload with vasodilatators.B-type Natriuretic Peptide has been shown to be very helpful in assessment of diagnosis, prognosis and severity of HF.

The third heart sound (S3) results from vigorous filling of the ventricle early in diastole and is present in many normal, asymptomatic individuals below the age of 40. However, in patients with symptoms consistent with HF, especially patients above the age of 40, the S3 is highly specific for HF Aim:To test the hypotheses that an early goal-directed decrement of preload and afterload with a target systolic blood pressure of 90-110 mmHg by aggressive vasodilatation in patients with acute HF in the non-ICU setting will leads to a faster decrement of BNP levels and to a faster disappearance of S3.

Design: Prospective, randomized, controlled, open label, single centre, interventional study Setting: University Hospital Basel Patients: Patients with acute HF not requiring ICU admission

Patients admitted to the emergency department with acute HF will be randomized to:

Early goal-directed preload and afterload decrement using a fixed therapy schedule including sublingual and transdermal nitrates, and hydralazine, followed by rapid up-titration of ACE-inhibitors or AT-receptor blockers to achieve maximal vasodilatation with a target systolic blood pressure of 90-110 mmHg. All other elements of treatment will be according to the current guidelines of the European Society of Cardiology (ESC)
Standard treatment of acute HF according to the current guidelines of the ESC.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acute HF
Age > 40 years
Informed consent

Exclusion Criteria:

Cardiopulmonary resuscitation < 7 days
Cardiogenic shock, ST-elevation myocardial infarction, or other clinical conditions that require immediate ICU admission or urgent PTCA
Systolic blood pressure lower than 100 mmHg at presentation
Primary rhythmogenic cause of acute decompensation (ventricular tachycardia, reentry tachycardia, atrial fibrillation or atrial flutter with a ventricular rate exceeding 140 beats per minute)
NSTEMI as primary diagnosis
Severe aortic stenosis
Adult congenital heart disease as primary cause of acute HF
Hypertrophic obstructive cardiomyopathy
Chronic kidney disease with creatinin levels > 250 µmol/l
Bilateral renal artery stenosis
Severe sepsis or other causes of high output failure
Cirrhosis of the liver CHILD class C
Previous adverse reactions to nitrates

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514384

Contacts

Contact: Christian Mueller, MD

0041-61-2655826

muellerch@uhbs.ch

Locations

Switzerland
University Hospital Basel
Basel, Switzerland, 4032

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator:

Mueller Christian, MD

University Hospital Basel

More Information

Study ID Numbers:	Serial BNP in ADHF
Study First Received:	August 8, 2007
Last Updated:	August 8, 2007
ClinicalTrials.gov Identifier:	NCT00514384
Health Authority:	Switzerland: Ethikkommission

Study placed in the following topic categories:

Nitroglycerin
Candesartan cilexetil
Heart Failure
Heart Diseases

Candesartan
Angiotensin II
Ramipril

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009