Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease - Full Text View

Sponsor:	NHS Greater Glasgow and Clyde
Information provided by:	NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:	NCT00702156

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Heart Failure

Drug Information available for: Bisoprolol Bisoprolol fumarate

U.S. FDA Resources

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
1: Experimental 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.
2: Placebo Comparator 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

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

Locations

United Kingdom, Scotland
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 National Clinical Trials Identifier (NCT ID):

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. Epub 2009 May 21.

Responsible Party:	Glasgow Royal Infirmary ( Dr Nathaniel Hawkins )
Study ID Numbers:	RN05CA013
Study First Received:	June 19, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00702156 History of Changes
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:

Sympatholytics
Heart Failure
Neurotransmitter Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Respiration Disorders
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Lung Diseases, Obstructive
Bisoprolol
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Peripheral Nervous System Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 22, 2009