Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

Phase 2

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease; Heart Failure
• Interventions: Drug: Placebo; Drug: Bisoprolol

• Registration Number: NCT00702156
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2008-02
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Study Completion: 2008-07
• Status Verified: 2008-08
• Last Update Submitted: 2008-09-02
• Last Update Posted: 2008-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Identical appearance matching placebo
1	Bisoprolol	Bisoprolol

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume 1 second (FEV1)	16 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life: Minnesota Living with Heart Failure, SF-36	16 weeks
NYHA Class	16 weeks

Trial Locations

Locations (1)

Cardiopulmonary Transplant Unit Glasgow Royal Infirmary; 🇬🇧 Glasgow, Scotland, United Kingdom