Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

September 2, 2008 updated by: NHS Greater Glasgow and Clyde

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Bisoprolol
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.
Other Names:
  • Bisoprolol Fumarate
  • Brand name: Cardicor
PLACEBO_COMPARATOR: 2
Identical appearance matching placebo
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced expiratory volume 1 second (FEV1)
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Investigators

  • Principal Investigator: Nathaniel M Hawkins, MBChB, NHS Greater Glasgow and Clyde
  • Study Chair: Francis G Dunn, MBChB MD, NHS Greater Glasgow and Clyde
  • Study Director: Roger Carter, BSc MSc PHD, NHS Greater Glasgow and Clyde
  • Study Director: George W Chalmers, MBChB MD, NHS Greater Glasgow and Clyde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (ESTIMATE)

June 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2008

Last Update Submitted That Met QC Criteria

September 2, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN05CA013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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