Status:
WITHDRAWN
A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure
Lead Sponsor:
The Alfred
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Heart Failure
Chronic Obstructive Airway Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00384566
Start Date
June 1 2005
End Date
April 1 2008
Last Update
June 24 2015
Active Locations (1)
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1
Alfred Hospital
Melbourne, Victoria, Australia, 3004