| June 19, 2008 |
| September 2, 2008 |
| March 2005 |
| February 2008 (final data collection date for primary outcome measure) |
| Forced expiratory volume 1 second (FEV1) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00702156 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease |
| 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. |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Heart Failure
- Chronic Obstructive Pulmonary Disease
|
- Drug: Bisoprolol
- Drug: Placebo
|
- Experimental: Bisoprolol
- Placebo Comparator: Identical appearance matching placebo
|
| 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. |
| |
| Terminated |
| 27 |
| July 2008 |
| February 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United Kingdom |
| |
| NCT00702156 |
| Dr Nathaniel Hawkins, Glasgow Royal Infirmary |
| RN05CA013 |
| 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 |
|
|
| NHS Greater Glasgow and Clyde |
| August 2008 |