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

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.

Study Type: Interventional

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

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Carvedilol
  • anit hypertensive medication
• Drug: Metoprolol
  • Anti hypertensive medication

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

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

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The Alfred

Overall Clinical Trial Officials and Contacts

Henry Krum, Professor Principal Investigator Monash University / Alfred Hospital  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384566

Study ID Number: CP-03/04

ClinicalTrials.gov Identifier: NCT00384566

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration