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Trial record 5 of 7 for:    "Lung Disease" | "Metoprolol"

A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00384566
Recruitment Status : Withdrawn (In order to join forces with another study already running which aims to answer the same question.)
First Posted : October 6, 2006
Last Update Posted : June 24, 2015
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
The Alfred

Tracking Information
First Submitted Date  ICMJE October 5, 2006
First Posted Date  ICMJE October 6, 2006
Last Update Posted Date June 24, 2015
Study Start Date  ICMJE June 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
  • Respiratory function [ Time Frame: Each study visit ]
  • NYHA class with the use of the 7 point scale (Packer). [ Time Frame: Baseline, cross over, end of study ]
  • Minnesota "living with Heart Failure" questionnaire. [ Time Frame: Baseline, cross over, end of study ]
  • U+E [ Time Frame: Screening, cross over, end of study ]
  • BP and HR [ Time Frame: every visit ]
  • plasma N-terminal pro-BNP [ Time Frame: Screening, cross over, end of study ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2006)
  • 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
Change History Complete list of historical versions of study NCT00384566 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Chronic Obstructive Airway Disease
Intervention  ICMJE
  • Drug: Carvedilol
    anit hypertensive medication
  • Drug: Metoprolol
    Anti hypertensive medication
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Carvedilol
  • Active Comparator: 2
    Intervention: Drug: Metoprolol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 6, 2008)
0
Original Enrollment  ICMJE
 (submitted: October 5, 2006)
45
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00384566
Other Study ID Numbers  ICMJE CP-03/04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Henry Krum, Monash University / Alfred Hospital
Study Sponsor  ICMJE The Alfred
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Henry Krum, Professor Monash University / Alfred Hospital
PRS Account The Alfred
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP