Chronic Heart FailurePhase 4CARNEBINCT00517725
Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure
A Phase 4 study testing carvedilol, bisoprolol and Nebivolol in people with Chronic Heart Failure, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
The investigators test the hypothesis that different beta-blockers had a different influence on chemoreceptor response and lung diffusion capacity. Both could influence exercise capacity in normoxic as well as hypoxic conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- carvedilol, bisoprolol and Nebivolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2007to May 2010
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure patients in stable clinical condition
Who cannot join
- No comorbidity
- NYHA class IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure: Effects on Exercise Capacity and Hypoxia, Chemoreceptor Response, Pulmonary Function
The investigators test the hypothesis that different beta-blockers had a different influence on chemoreceptor response and lung diffusion capacity.
Both could influence exercise capacity in normoxic as well as hypoxic conditions.
- Conditions
- Chronic Heart Failure
- Being tested
- carvedilol, bisoprolol, Nebivolol
- Keywords
- exercise, lung diffusion, hypoxia, chemoreceptor, beta-blockers, heart failure
- Medical subject headings
- Motor Activity, Hypoxia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carvedilolDrug
bisoprololDrug
NebivololDrug
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Active comparator | Not described Receives: Drug: carvedilol |
| Bisoprolol | Active comparator | Not described Receives: Drug: bisoprolol |
| Nebivolol | Active comparator | Not described Receives: Drug: Nebivolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
Measured: two months
Secondary outcomes (1)
lung diffusion
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startJul 2007
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Investigators
- Piergiuseppe Agostoni, MD, PhD, Principal investigator, Centro Cardiologico MonzinoGiancarlo Marenzi, MD, Study chair, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517725
- Sponsor's protocol ID
- R76-CCM S78/407
- Acronym
- CARNEBI
- Status last verified
- Sep 2010
- First submitted
- 16 Aug 2007
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Agostoni P, Bussotti M, Cattadori G, Margutti E, Contini M, Muratori M, Marenzi G, Fiorentini C. Gas diffusion and alveolar-capillary unit in chronic heart failure. Eur Heart J. 2006 Nov;27(21):2538-43. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.
PubMed 17028107Karsten M, Contini M, Cefalu C, Cattadori G, Palermo P, Apostolo A, Bussotti M, Magri D, Salvioni E, Farina S, Sciomer S, Catai AM, Agostoni P. Effects of carvedilol on oxygen uptake and heart rate kinetics in patients with chronic heart failure at simulated altitude. Eur J Prev Cardiol. 2012 Jun;19(3):444-51. doi: 10.1177/1741826711402736. Epub 2011 Mar 7.
PubMed 21450573
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure: Effects on Exercise Capacity and Hypoxia, Chemoreceptor Response, Pulmonary Function
- ClinicalTrials.gov ID
- NCT00517725
- Acronym / sponsor ID
- CARNEBI / R76-CCM S78/407
- Conditions
- Chronic Heart Failure
- Keywords
- exercise, lung diffusion, hypoxia, chemoreceptor, beta-blockers, heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Jul 2007
- Study completion
- May 2010 (actual)
- First posted
- 17 Aug 2007 (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 investigators test the hypothesis that different beta-blockers had a different influence on chemoreceptor response and lung diffusion capacity.
Both could influence exercise capacity in normoxic as well as hypoxic conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Active comparator | Drug: carvedilol |
| Bisoprolol | Active comparator | Drug: bisoprolol |
| Nebivolol | Active comparator | Drug: Nebivolol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic heart failure patients in stable clinical condition
Key exclusion criteria (2 listed)
- No comorbidity
- NYHA class IV
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 |
|---|---|---|
| carvedilol | Drug | Carvedilol |
| bisoprolol | Drug | Bisoprolol |
| Nebivolol | Drug | Nebivolol |
Primary outcome
exercise capacity
Time frame: two months
1 secondary outcome
lung diffusion
Time frame: two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2010.
- Background: PubMed 17028107Agostoni P, Bussotti M, Cattadori G, Margutti E, Contini M, Muratori M, Marenzi G, Fiorentini C. Gas diffusion and alveolar-capillary unit in chronic heart failure. Eur Heart J. 2006 Nov;27(21):2538-43. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.
- Derived from this study: PubMed 21450573Karsten M, Contini M, Cefalu C, Cattadori G, Palermo P, Apostolo A, Bussotti M, Magri D, Salvioni E, Farina S, Sciomer S, Catai AM, Agostoni P. Effects of carvedilol on oxygen uptake and heart rate kinetics in patients with chronic heart failure at simulated altitude. Eur J Prev Cardiol. 2012 Jun;19(3):444-51. doi: 10.1177/1741826711402736. Epub 2011 Mar 7.
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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.
Piergiuseppe Agostoni, MD, PhD principal investigator
Centro Cardiologico Monzino
Giancarlo Marenzi, MD study chair
Centro Cardiologico Monzino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carvedilol, bisoprolol and Nebivolol in people with Chronic Heart Failure, run by Centro Cardiologico Monzino at 1 site in Italy.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 16 Sep 2010. 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 Italy. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
exercise capacity (time frame: two months). 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 NCT00517725, which also lists 2 linked publications.
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 16 Sep 2010.