Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

Condition(s) targeted: Heart Failure; Chronic Obstructive Pulmonary Disease

Intervention: Bisoprolol (Drug); Placebo (Drug)

Phase: Phase 2

Status: Suspended

Sponsored by: NHS Greater Glasgow and Clyde

Official(s) and/or principal investigator(s):
Nathaniel M Hawkins, MBChB, Principal Investigator, Affiliation: NHS Greater Glasgow and Clyde
Francis G Dunn, MBChB MD, Study Chair, Affiliation: NHS Greater Glasgow and Clyde
Roger Carter, BSc MSc PHD, Study Director, Affiliation: NHS Greater Glasgow and Clyde
George W Chalmers, MBChB MD, Study Director, Affiliation: NHS Greater Glasgow and Clyde

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: 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.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Forced expiratory volume 1 second (FEV1)

Secondary outcome:

Quality of life: Minnesota Living with Heart Failure, SF-36

NYHA Class

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Cardiopulmonary Transplant Unit Glasgow Royal Infirmary, Glasgow, Scotland G31 2ER, United Kingdom

Starting date: March 2005
Ending date: August 2008
Last updated: June 19, 2008