Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
27 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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