Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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Cardioselective Beta-Blockade Using Bisoprolol in Patients With Chronic Heart Failure (CHF) and Coexistent Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) With or Without Significant Reversibility.

Conditions
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Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Bisoprolol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic NYHA II or III chronic heart failure left ventricular systolic dysfunction moderate or severe chronic obstructive pulmonary disease with or without significant reversibility Exclusion Criteria: beta-blocker contraindications non-dihydropyridine (diltiazem / verapamil) calcium channel blockers recent coronary percutaneous intervention or coronary artery bypass graft surgery haemodynamically significant valvular disease or hypertrophic cardiomyopathy. active myocarditis or pericarditis. recent cerebrovascular accident or transient ischaemic attack serious concurrent systemic disease, such as malignancy, resulting in likely reduced life expectancy pregnancy, childbearing potential with inadequate contraception, breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bisoprolol | Drug: Bisoprolol<br>* Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.<br>* Other names: Brand name: Cardicor;|
| Placebo Comparator: 2<br>Identical appearance matching placebo | Drug: Placebo<br>* Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume 1 second (FEV1) |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life: Minnesota Living with Heart Failure, SF-36 |  | 16 weeks | 
| NYHA Class |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Chronic Obstructive Pulmonary Disease, Beta-blockers, Pulmonary Function