Heart FailurePhase 2NCT00702156
Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Bisoprolol in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bisoprolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2005to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic NYHA II or III chronic heart failure
- left ventricular systolic dysfunction
- moderate or severe chronic obstructive pulmonary disease
- with or without significant reversibility
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiopulmonary Transplant Unit Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER
About this 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.
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.
- Being tested
- Bisoprolol, Placebo
- Keywords
- Heart Failure, Chronic Obstructive Pulmonary Disease, Beta-blockers, Pulmonary Function
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisoprololDrug
Also called Bisoprolol Fumarate, Brand name: Cardicor
Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
PlaceboDrug
Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bisoprolol Receives: Drug: Bisoprolol |
| 2 | Placebo comparator | Identical appearance matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume 1 second (FEV1)
Measured: 16 weeks
Secondary outcomes (2)
Quality of life: Minnesota Living with Heart Failure, SF-36
Measured: 16 weeks
NYHA Class
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startMar 2005
- Primary completionFeb 2008
- Study completionJul 2008
Why it stopped: Inadequate patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Investigators
- Nathaniel M Hawkins, MBChB, Principal investigator, NHS Greater Glasgow and ClydeFrancis G Dunn, MBChB MD, Study chair, NHS Greater Glasgow and ClydeRoger Carter, BSc MSc PHD, Study director, NHS Greater Glasgow and ClydeGeorge W Chalmers, MBChB MD, Study director, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702156
- Sponsor's protocol ID
- RN05CA013
- Status last verified
- Aug 2008
- First submitted
- 19 Jun 2008
- Last updated
- 3 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19460848
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00702156
- Acronym / sponsor ID
- RN05CA013
- Keywords
- Heart Failure, Chronic Obstructive Pulmonary Disease, Beta-blockers, Pulmonary Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate patient recruitment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BisoprololBisoprolol |
| 2 | Placebo comparator | Drug: PlaceboIdentical appearance matching placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptomatic NYHA II or III chronic heart failure
- left ventricular systolic dysfunction
- moderate or severe chronic obstructive pulmonary disease
- with or without significant reversibility
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BisoprololAlso: Bisoprolol Fumarate, Brand name: CardicorTitration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks. | Drug | 1 |
| PlaceboTitration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks. | Drug | 2 |
Primary outcome
Forced expiratory volume 1 second (FEV1)
Time frame: 16 weeks
2 secondary outcomes
Quality of life: Minnesota Living with Heart Failure, SF-36
Time frame: 16 weeks
NYHA Class
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Inadequate patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2008.
- Derived from this study: PubMed 19460848Hawkins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel M Hawkins, MBChB principal investigator
NHS Greater Glasgow and Clyde
Francis G Dunn, MBChB MD study chair
NHS Greater Glasgow and Clyde
Roger Carter, BSc MSc PHD study director
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bisoprolol in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inadequate patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume 1 second (FEV1) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2008.