Clinical trial NCT00702156: Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Keywords: Heart Failure
Chronic Obstructive Pulmonary Disease
Beta-blockers
Pulmonary Function
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2008-06-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Forced expiratory volume 1 second (FEV1)
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of life: Minnesota Living with Heart Failure, SF-36
timeFrame: 16 weeks
measure: NYHA Class
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Cardiopulmonary Transplant Unit Glasgow Royal Infirmary
state: Scotland
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Nathaniel M Hawkins, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Greater Glasgow and Clyde
name: Francis G Dunn, MBChB MD
role: STUDY_CHAIR
affiliation: NHS Greater Glasgow and Clyde
name: Roger Carter, BSc MSc PHD
role: STUDY_DIRECTOR
affiliation: NHS Greater Glasgow and Clyde
name: George W Chalmers, MBChB MD
role: STUDY_DIRECTOR
References:
citation: 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.