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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00384566




Registration number
NCT00384566
Ethics application status
Date submitted
5/10/2006
Date registered
6/10/2006
Date last updated
24/06/2015

Titles & IDs
Public title
A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure
Scientific title
The CAMERA Study: CArvedilol MEtoprolol Respiratory Assessment Investigator Trial
Secondary ID [1] 0 0
CP-03/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Chronic Obstructive Airway Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carvedilol
Treatment: Drugs - Metoprolol

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: Carvedilol
anit hypertensive medication

Treatment: Drugs: Metoprolol
Anti hypertensive medication
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Respiratory function
Timepoint [1] 0 0
Each study visit
Primary outcome [2] 0 0
NYHA class with the use of the 7 point scale (Packer).
Timepoint [2] 0 0
Baseline, cross over, end of study
Primary outcome [3] 0 0
Minnesota "living with Heart Failure" questionnaire.
Timepoint [3] 0 0
Baseline, cross over, end of study
Primary outcome [4] 0 0
U+E
Timepoint [4] 0 0
Screening, cross over, end of study
Primary outcome [5] 0 0
BP and HR
Timepoint [5] 0 0
every visit
Primary outcome [6] 0 0
plasma N-terminal pro-BNP
Timepoint [6] 0 0
Screening, cross over, end of study

Eligibility
Key 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 ß-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 ß adrenoceptor blockade but not currently
prescribed a ß-blocker.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Roche Pharma AG
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00384566
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, Professor
Address 0 0
Monash University / Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00384566