Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

This study has been terminated.
(Inadequate patient recruitment)
Sponsor:
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00702156
First received: June 19, 2008
Last updated: September 2, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Heart Failure
Chronic Obstructive Pulmonary Disease
Drug: Bisoprolol
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Forced expiratory volume 1 second (FEV1) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life: Minnesota Living with Heart Failure, SF-36 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • NYHA Class [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: March 2005
Study Completion Date: July 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702156

Locations
United Kingdom
Cardiopulmonary Transplant Unit Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G31 2ER
Sponsors and Collaborators
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
  More Information

No publications provided by NHS Greater Glasgow and Clyde

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Nathaniel Hawkins, Glasgow Royal Infirmary
ClinicalTrials.gov Identifier: NCT00702156     History of Changes
Other Study ID Numbers: RN05CA013
Study First Received: June 19, 2008
Last Updated: September 2, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:
Heart Failure
Chronic Obstructive Pulmonary Disease
Beta-blockers
Pulmonary Function

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Bisoprolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014