Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease
NCT00702156 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2008-09-03
Summary
The principal research objectives are to demonstrate cardioselective beta-blockade using bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality of life in patients with heart failure and coexistent moderate or severe chronic obstructive pulmonary disease with or without significant reversibility. Patients will be followed up for 4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated dose. Health status will be assessed using a generic and two disease specific questionnaires, and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise testing.
Conditions
Interventions
- DRUG
-
Bisoprolol
Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
- DRUG
-
Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
Sponsors & Collaborators
-
NHS Greater Glasgow and Clyde
lead OTHER
Principal Investigators
-
Nathaniel M Hawkins, MBChB · NHS Greater Glasgow and Clyde
-
Francis G Dunn, MBChB MD · NHS Greater Glasgow and Clyde
-
Roger Carter, BSc MSc PHD · NHS Greater Glasgow and Clyde
-
George W Chalmers, MBChB MD · NHS Greater Glasgow and Clyde
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-03-31
- Primary Completion
- 2008-02-29
- Completion
- 2008-07-31
Countries
- United Kingdom
Study Locations
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