A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Heart Failure Chronic Obstructive Airway Disease |
| Intervention | Drug: Carvedilol Drug: Metoprolol |
| Phase | Phase 4 |
| Sponsor | The Alfred |
| Responsible Party | The Alfred |
| ClinicalTrials.gov Identifier | NCT00384566 |
| First Received | October 5, 2006 |
| Last Updated | May 6, 2008 |
| Last verified | May 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 5, 2006 |
|---|---|
| Last Updated Date | May 6, 2008 |
| Start Date | June 2005 |
| Estimated Primary Completion Date | April 2008 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure |
|---|---|
| Official Title | The CAMERA Study: CArvedilol MEtoprolol Respiratory Assessment Investigator Trial |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Carvedilol anit hypertensive medication Drug: Metoprolol Anti hypertensive medication |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | April 2008 |
| Estimated Primary Completion Date | April 2008 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Australia |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00384566 |
|---|---|
| Other Study ID Numbers | CP-03/04 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | The Alfred |
| Study Sponsor | The Alfred |
| Collaborators | Hoffmann-La Roche |
| Investigators | Principal Investigator: Henry Krum, Professor Monash University / Alfred Hospital |
| Verification Date | May 2008 |
Locations[ + expand ][ + ]
| Alfred Hospital | Melbourne, Victoria, Australia, 3004 |
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