Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

This study has been terminated.
(Inadequate patient recruitment)
Information provided by:
NHS Greater Glasgow and Clyde Identifier:
First received: June 19, 2008
Last updated: September 2, 2008
Last verified: August 2008
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • Quality of life: Minnesota Living with Heart Failure, SF-36 [ Time Frame: 16 weeks ]
  • NYHA Class [ Time Frame: 16 weeks ]

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
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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00702156

United Kingdom
Cardiopulmonary Transplant Unit Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G31 2ER
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Nathaniel Hawkins, Glasgow Royal Infirmary Identifier: NCT00702156     History of Changes
Other Study ID Numbers: RN05CA013
Study First Received: June 19, 2008
Last Updated: September 2, 2008

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

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Antihypertensive Agents
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 processed this record on May 25, 2017