Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00702156

Enrollment

Registered

2008-06-20

Start date

2005-03-31

Completion date

2008-07-31

Last updated

2008-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Heart Failure

Keywords

Heart Failure, Chronic Obstructive Pulmonary Disease, Beta-blockers, Pulmonary Function

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.

Interventions

DRUGBisoprolol

Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.

DRUGPlacebo

Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Forced expiratory volume 1 second (FEV1)	16 weeks

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026