A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure
Primary Purpose
Heart Failure, Chronic Obstructive Airway Disease
Status
Withdrawn
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Carvedilol
Metoprolol
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- Alfred Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Respiratory function
NYHA class with the use of the 7 point scale (Packer).
Minnesota "living with Heart Failure" questionnaire.
U+E
BP and HR
plasma N-terminal pro-BNP
Secondary Outcome Measures
Full Information
NCT ID
NCT00384566
First Posted
October 5, 2006
Last Updated
June 23, 2015
Sponsor
The Alfred
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT00384566
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
In order to join forces with another study already running which aims to answer the same question.
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Alfred
Collaborators
Roche Pharma AG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Chronic Obstructive Airway Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Description
anit hypertensive medication
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Intervention Description
Anti hypertensive medication
Primary Outcome Measure Information:
Title
Respiratory function
Time Frame
Each study visit
Title
NYHA class with the use of the 7 point scale (Packer).
Time Frame
Baseline, cross over, end of study
Title
Minnesota "living with Heart Failure" questionnaire.
Time Frame
Baseline, cross over, end of study
Title
U+E
Time Frame
Screening, cross over, end of study
Title
BP and HR
Time Frame
every visit
Title
plasma N-terminal pro-BNP
Time Frame
Screening, cross over, end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Krum, Professor
Organizational Affiliation
Monash University / Alfred Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure
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