Chronic Heart FailureNCT00511888
Nebivolol Versus Carvedilol in Patients With Heart Failure
An observational study of Chronic Heart Failure and Hypertension, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
BACKGROUND Beta-blockers improve left ventricular (LV) systolic function and prognosis in patients with chronic heart failure. Both carvedilol and nebivolol have hemodynamic and clinical benefits in chronic heart failure (CHF), but it is unknown whether their pleiotropic properties may play a role in different… Read more about this study
- Who is it for?
- Ages 53 to 76 years
- Conditions the study is for
- Chronic Heart Failure, Hypertension
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to Jun 2007
- Phase
- Observational
- 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 53 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- left ventricular ejection fraction (LVEF) < 40%;
- symptomatic heart failure with functional New York Heart Association (NYHA) class II or III;
- arterial hypertension with systolic blood pressure >140 mmHg and diastolic blood pressure >85 mmHg;
- clinical stability without hospital admission for heart failure in the previous 3 months.
Who cannot join
- history of asthma or severe chronic obstructive pulmonary disease;
- severe liver or kidney diseases;
- second-degree or third degree heart block without a permanent pacemaker,
- sick sinus syndrome, heart rate <60 beat/min, systolic blood pressure <90 mmHg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure
BACKGROUND Beta-blockers improve left ventricular (LV) systolic function and prognosis in patients with chronic heart failure. Both carvedilol and nebivolol have hemodynamic and clinical benefits in chronic heart failure (CHF), but it is unknown whether their pleiotropic properties may play a role in different subgroups of patients with CHF.
OBJECTIVE: To compare the effects of nebivolol and carvedilol on LV function and clinical outcome in patients with chronic heart failure and reduced LV systolic function.
METHODS: 160 hypertensive CHF patients, LV ejection fraction (EF) 40% and in New York Heart Association (NYHA) functional class II or III were randomly assigned to receive carvedilol or nebivolol therapy for 24 months. At baseline and after 24 months of treatment, all patients underwent clinical evaluation: echocardiogram and 6-minute walking test.
- Conditions
- Chronic Heart Failure, Hypertension
- Keywords
- chronic heart failure, hypertension, beta blockers
- Medical subject headings
- Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startJan 2004
- Study completionJun 2007
Why it stopped: is finish
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- giuseppe rosano, md, Study director, IRCCS san Raffaele Cardiovascular Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511888
- Sponsor's protocol ID
- 001-07
- Status last verified
- Aug 2007
- First submitted
- 3 Aug 2007
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00511888
- Acronym / sponsor ID
- 001-07
- Conditions
- Chronic Heart Failure, Hypertension
- Keywords
- chronic heart failure, hypertension, beta blockers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: is finish
- Enrolment
- 160 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Jun 2007 (actual)
- First posted
- 6 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.
BACKGROUND Beta-blockers improve left ventricular (LV) systolic function and prognosis in patients with chronic heart failure. Both carvedilol and nebivolol have hemodynamic and clinical benefits in chronic heart failure (CHF), but it is unknown whether their pleiotropic properties may play a role in different subgroups of patients with CHF.
OBJECTIVE: To compare the effects of nebivolol and carvedilol on LV function and clinical outcome in patients with chronic heart failure and reduced LV systolic function.
METHODS: 160 hypertensive CHF patients, LV ejection fraction (EF) 40% and in New York Heart Association (NYHA) functional class II or III were randomly assigned to receive carvedilol or nebivolol therapy for 24 months. At baseline and after 24 months of treatment, all patients underwent clinical evaluation: echocardiogram and 6-minute walking test.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 53 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- left ventricular ejection fraction (LVEF) < 40%;
- symptomatic heart failure with functional New York Heart Association (NYHA) class II or III;
- arterial hypertension with systolic blood pressure >140 mmHg and diastolic blood pressure >85 mmHg;
- clinical stability without hospital admission for heart failure in the previous 3 months.
Key exclusion criteria (4 listed)
- history of asthma or severe chronic obstructive pulmonary disease;
- severe liver or kidney diseases;
- second-degree or third degree heart block without a permanent pacemaker,
- sick sinus syndrome, heart rate <60 beat/min, systolic blood pressure <90 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: is finish). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
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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.
giuseppe rosano, md study director
IRCCS san Raffaele Cardiovascular Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure and Hypertension, run by IRCCS San Raffaele 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 4 inclusion and 4 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 17 Oct 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 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.
Are results available for this study?
The study was stopped early (reason given: is finish). 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.
Where can I read the original study information?
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 17 Oct 2008.