Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00702156
• Other study ID #: RN05CA013
• Status: Terminated
• Phase: Phase 2
• First received: June 19, 2008
• Last updated: September 2, 2008
• Start date: March 2005
• Est. completion date: July 2008

Study information

• Verified date: August 2008
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: July 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Cardiopulmonary Transplant Unit Glasgow Royal Infirmary	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume 1 second (FEV1)		16 weeks	No
Secondary	Quality of life: Minnesota Living with Heart Failure, SF-36		16 weeks	No
Secondary	NYHA Class		16 weeks	No