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Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

Primary Purpose

Heart Failure, Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Bisoprolol
Placebo
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Chronic Obstructive Pulmonary Disease, Beta-blockers, Pulmonary Function

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cardiopulmonary Transplant Unit Glasgow Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Bisoprolol

Identical appearance matching placebo

Outcomes

Primary Outcome Measures

Forced expiratory volume 1 second (FEV1)

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2008
Last Updated
September 2, 2008
Sponsor
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT00702156
Brief Title
Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease
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 Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
Inadequate patient recruitment
Study Start Date
March 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NHS Greater Glasgow and Clyde

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Chronic Obstructive Pulmonary Disease
Keywords
Heart Failure, Chronic Obstructive Pulmonary Disease, Beta-blockers, Pulmonary Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bisoprolol
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Identical appearance matching placebo
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Other Intervention Name(s)
Bisoprolol Fumarate, Brand name: Cardicor
Intervention Description
Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
Primary Outcome Measure Information:
Title
Forced expiratory volume 1 second (FEV1)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Quality of life: Minnesota Living with Heart Failure, SF-36
Time Frame
16 weeks
Title
NYHA Class
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel M Hawkins, MBChB
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis G Dunn, MBChB MD
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roger Carter, BSc MSc PHD
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
George W Chalmers, MBChB MD
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Study Director
Facility Information:
Facility Name
Cardiopulmonary Transplant Unit Glasgow Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G31 2ER
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19460848
Citation
Hawkins NM, MacDonald MR, Petrie MC, Chalmers GW, Carter R, Dunn FG, McMurray JJ. Bisoprolol in patients with heart failure and moderate to severe chronic obstructive pulmonary disease: a randomized controlled trial. Eur J Heart Fail. 2009 Jul;11(7):684-90. doi: 10.1093/eurjhf/hfp066. Epub 2009 May 21.
Results Reference
derived

Learn more about this trial

Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

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