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

NCT00384566 | Withdrawn Phase 4

• 1 other identifier: CP-03/04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Chronic Obstructive Airway Disease

Outcome Measures

Primary Outcomes (6)

• Respiratory function

  Each study visit

• NYHA class with the use of the 7 point scale (Packer).

  Baseline, cross over, end of study

• Minnesota "living with Heart Failure" questionnaire.

  Baseline, cross over, end of study

• U+E

  Screening, cross over, end of study

• BP and HR

  every visit

• plasma N-terminal pro-BNP

  Screening, cross over, end of study

Study Arms (2)

1

EXPERIMENTAL

Drug: Carvedilol

2

ACTIVE COMPARATOR

Drug: Metoprolol

Interventions

Carvedilol DRUG

anit hypertensive medication

1

Metoprolol DRUG

Anti hypertensive medication

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Interventions

Carvedilol; Metoprolol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenoxypropanolamines

Study Officials

• Henry Krum, Professor

  Monash University / Alfred Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 6, 2006
• Study Start: June 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

AU (1)