NCT00702156

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
Completed

Started Mar 2005

Typical duration for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 3, 2008

Status Verified

August 1, 2008

Enrollment Period

2.9 years

First QC Date

June 19, 2008

Last Update Submit

September 2, 2008

Conditions

Heart FailureChronic Obstructive Pulmonary Disease

Keywords

Heart FailureChronic Obstructive Pulmonary DiseaseBeta-blockersPulmonary Function

Outcome Measures

Primary Outcomes (1)

  • Forced expiratory volume 1 second (FEV1)

    16 weeks

Secondary Outcomes (2)

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

    16 weeks

  • NYHA Class

    16 weeks

Study Arms (2)

1

EXPERIMENTAL

Bisoprolol

Drug: Bisoprolol

2

PLACEBO COMPARATOR

Identical appearance matching placebo

Drug: Placebo

Interventions

BisoprololDRUG

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

Also known as: Bisoprolol Fumarate, Brand name: Cardicor
1
PlaceboDRUG

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic NYHA II or III chronic heart failure
  • left ventricular systolic dysfunction
  • moderate or severe chronic obstructive pulmonary disease
  • with or without significant reversibility

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiopulmonary Transplant Unit Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19460848DERIVED

MeSH Terms

Conditions

Heart FailurePulmonary Disease, Chronic Obstructive

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Nathaniel M Hawkins, MBChB

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

  • Francis G Dunn, MBChB MD

    NHS Greater Glasgow and Clyde

    STUDY CHAIR

  • Roger Carter, BSc MSc PHD

    NHS Greater Glasgow and Clyde

    STUDY DIRECTOR

  • George W Chalmers, MBChB MD

    NHS Greater Glasgow and Clyde

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

March 1, 2005

Primary Completion

February 1, 2008

Study Completion

July 1, 2008

Last Updated

September 3, 2008

Record last verified: 2008-08

Locations

GB(1)