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Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

NCT ID: NCT00702156

Last Updated: 2008-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Chronic Obstructive Pulmonary Disease

Keywords

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Heart Failure Chronic Obstructive Pulmonary Disease Beta-blockers Pulmonary Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Bisoprolol

Group Type EXPERIMENTAL

Bisoprolol

Intervention Type DRUG

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

2

Identical appearance matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Bisoprolol Fumarate Brand name: Cardicor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Glasgow Royal Infirmary

Principal Investigators

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Nathaniel M Hawkins, MBChB

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Francis G Dunn, MBChB MD

Role: STUDY_CHAIR

NHS Greater Glasgow and Clyde

Roger Carter, BSc MSc PHD

Role: STUDY_DIRECTOR

NHS Greater Glasgow and Clyde

George W Chalmers, MBChB MD

Role: STUDY_DIRECTOR

NHS Greater Glasgow and Clyde

Locations

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Cardiopulmonary Transplant Unit Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 19460848 (View on PubMed)

Other Identifiers

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RN05CA013

Identifier Type: -

Identifier Source: org_study_id