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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

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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Recruitment Status : Withdrawn (In order to join forces with another study already running which aims to answer the same question.)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

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.


Condition or disease Intervention/treatment Phase
Heart Failure Chronic Obstructive Airway Disease Drug: Carvedilol Drug: Metoprolol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The CAMERA Study: CArvedilol MEtoprolol Respiratory Assessment Investigator Trial
Study Start Date : June 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008


Arm Intervention/treatment
Experimental: 1 Drug: Carvedilol
anit hypertensive medication

Active Comparator: 2 Drug: Metoprolol
Anti hypertensive medication




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384566


Locations
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Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
Roche Pharma AG
Investigators
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Principal Investigator: Henry Krum, Professor Monash University / Alfred Hospital

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Responsible Party: Prof Henry Krum, Monash University / Alfred Hospital
ClinicalTrials.gov Identifier: NCT00384566     History of Changes
Other Study ID Numbers: CP-03/04
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Metoprolol
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Carvedilol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists