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Sponsors and Collaborators: |
The Alfred Hoffmann-La Roche |
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Information provided by: | The Alfred |
ClinicalTrials.gov Identifier: | NCT00384566 |
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 |
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Heart Failure Chronic Obstructive Airway Disease |
Drug: Carvedilol Drug: Metoprolol |
Phase IV |
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 |
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 |
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1: Experimental |
Drug: Carvedilol
anit hypertensive medication
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2: Active Comparator |
Drug: Metoprolol
Anti hypertensive medication
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Creatinine >0.30 mmol/l Liver function tests 3x ULN
Australia, Victoria | |
Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 |
Principal Investigator: | Henry Krum, Professor | Monash University / Alfred Hospital |
Responsible Party: | Monash University / Alfred Hospital ( Prof Henry Krum ) |
Study ID Numbers: | CP-03/04 |
Study First Received: | October 5, 2006 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00384566 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Vasodilator Agents Neurotransmitter Agents Heart Failure Heart Diseases Adrenergic Agents Adrenergic alpha-Antagonists Cardiovascular Agents Metoprolol Antihypertensive Agents Lung Diseases, Obstructive |
Respiratory Tract Diseases Lung Diseases Metoprolol succinate Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents Pulmonary Disease, Chronic Obstructive Carvedilol |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Anti-Arrhythmia Agents Carvedilol Heart Failure |
Sympatholytics Heart Diseases Adrenergic alpha-Antagonists Cardiovascular Agents Metoprolol Antihypertensive Agents Pharmacologic Actions Autonomic Agents Metoprolol succinate Lung Diseases Adrenergic Antagonists Peripheral Nervous System Agents Pulmonary Disease, Chronic Obstructive |