A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure - Full Text View

Purpose

This study looks at the effect of two drugs (carvedilol and metoprolol) which are used for patients with CHF (chronic heart failure).

These agents are beta-blockers and, although effective in heart failure, may cause increases in airways tone and thus limit air getting into the lower parts of the lungs. Carvedilol is more active at blocking the receptor that opens up the airways and therefore theoretically may be more likely to reduce airways tone than metoprolol, although this has never been studied in patients with heart failure, and that is the purpose of the present study.

We are looking to enrol 45 patients with heart failure and mild obstruction to the flow of air in their lungs. Patients will be randomised to either carvedilol or metoprolol (standard doses). Following a minimum of 2 weeks of therapy of study medication the patient will undergo a study day involving an assessment of their lung function, an assessment of their heart failure, a "living with heart failure" questionnaire, blood tests and blood pressure and heart rate readings.

Patients will then be crossed over to the alternate medication. Following 2 weeks on the target dose the patient will undergo their second study day which will be the same as the first.

The results obtained from each study day will be compared.

Condition	Intervention	Phase
Heart Failure Chronic Obstructive Airway Disease	Drug: Carvedilol Drug: Metoprolol	Phase IV

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease) Heart Failure

Drug Information available for:

Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate Carvedilol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	The CAMERA Study: CArvedilol MEtoprolol Respiratory Assessment Investigator Trial

Further study details as provided by The Alfred:

Primary Outcome Measures:

Respiratory function [ Time Frame: Each study visit ] [ Designated as safety issue: Yes ]
NYHA class with the use of the 7 point scale (Packer). [ Time Frame: Baseline, cross over, end of study ] [ Designated as safety issue: Yes ]
Minnesota "living with Heart Failure" questionnaire. [ Time Frame: Baseline, cross over, end of study ] [ Designated as safety issue: No ]
U+E [ Time Frame: Screening, cross over, end of study ] [ Designated as safety issue: Yes ]
BP and HR [ Time Frame: every visit ] [ Designated as safety issue: No ]
plasma N-terminal pro-BNP [ Time Frame: Screening, cross over, end of study ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	June 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Carvedilol anit hypertensive medication
2: Active Comparator	Drug: Metoprolol Anti hypertensive medication

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

males and females over 18 years of age
Documented CHF (NYHA class II-IV symptoms)
Airflow obstruction defined as patients with symptomatic obstructive respiratory disease as manifest by any of the following Symptoms of wheeze, primarily attributed to airflow obstruction Requirement for intermittent or regular bronchodilator therapy FEV1 less than 70% predicted pre-salbutamol
Confirmed written informed consent.
Clinically indicated to receive β-blockade.
No evidence of heart block on ECG.
Patients will be in one of the following categories:

Currently on carvedilol Currently on Toprol-XL or Metoprolol tartrate Currently on bisoprolol Clinically indicated to receive β adrenoceptor blockade but not currently prescribed a β-blocker.

Exclusion Criteria:

Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.
Patients who had received an investigational new drug within the last 4 weeks.
Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
Laboratory parameters:

Creatinine >0.30 mmol/l Liver function tests 3x ULN

Recent (<12 months) myocarditis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384566

Locations


Australia, Victoria
	Alfred Hospital
	Melbourne, Victoria, Australia, 3004

Sponsors and Collaborators

The Alfred

Hoffmann-La Roche

Investigators


Principal Investigator:	Henry Krum, Professor	Monash University / Alfred Hospital

More Information

Responsible Party:	Monash University / Alfred Hospital ( Prof Henry Krum )
Study ID Numbers:	CP-03/04
First Received:	October 5, 2006
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00384566
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Heart Failure

Lung Diseases, Obstructive

Heart Diseases

Respiratory Tract Diseases

Metoprolol succinate

Lung Diseases

Metoprolol

Carvedilol

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Vasodilator Agents

Neurotransmitter Agents

Sympatholytics

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Adrenergic alpha-Antagonists

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Adrenergic beta-Antagonists

Cardiovascular Diseases

Adrenergic Antagonists

Peripheral Nervous System Agents

Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on October 29, 2008

Sponsors and Collaborators:	The Alfred Hoffmann-La Roche
Information provided by:	The Alfred
ClinicalTrials.gov Identifier:	NCT00384566