Ventricular DysfunctionNCT00213902
Clonidine and Left Ventricular Dysfunction
An observational study of Ventricular Dysfunction, run by University Hospital, Strasbourg, France.
Trial summary
The objectives of this study are: 1. To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (DHF). 2. To evaluate the effect of clonidine on neurohormones and quality of life in patients with DHF. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Ventricular Dysfunction
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to not given
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 60 and greater
- Gender: Both
- Patients with heart failure New York Heart Association (NYHA) II and ejection fraction over 45%
Who cannot join
None listed.
About this study
Official title: Evaluation of Effects of Central Sympathetic Inhibition in Elderly With Left Ventricular Diastolic Dysfunction and Preserved Ejection Fraction: A Proof-of-Concept Trial With Clonidine
The objectives of this study are:
- To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (DHF).
- To evaluate the effect of clonidine on neurohormones and quality of life in patients with DHF.
Read more
The study is a double-blind, placebo-controlled study evaluating the effects of clonidine compared to placebo in patients with DHF. A total of 70 patients with DHF will be randomized in a 1:1 ratio to:
- placebo (n=35) or to
- clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by uptitration to 0.150 mg twice a day for 6 months.
The primary outcome is the reversion of cardiac remodeling and hemodynamic parameters evaluated by magnetic resonance imaging (MRI) and echocardiography.
- Conditions
- Ventricular Dysfunction
- Keywords
- Heart failure, Diastolic, functionClonidine, Left ventricular diastolic dysfunction with preserved ejection fraction
- Medical subject headings
- Ventricular Dysfunction, Heart Failure, Heart Murmurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular DysfunctionStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Pascal Bousquet, MD, Principal investigator, Hopitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213902
- Sponsor's protocol ID
- 3153
- Status last verified
- Nov 2007
- First submitted
- 13 Sep 2005
- Last updated
- 29 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effects of Central Sympathetic Inhibition in Elderly With Left Ventricular Diastolic Dysfunction and Preserved Ejection Fraction: A Proof-of-Concept Trial With Clonidine
- ClinicalTrials.gov ID
- NCT00213902
- Acronym / sponsor ID
- 3153
- Conditions
- Ventricular Dysfunction
- Keywords
- Heart failure, Diastolic, functionClonidine, Left ventricular diastolic dysfunction with preserved ejection fraction
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2004
- First posted
- 21 Sep 2005 (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 objectives of this study are:
- To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (DHF).
- To evaluate the effect of clonidine on neurohormones and quality of life in patients with DHF.
The study is a double-blind, placebo-controlled study evaluating the effects of clonidine compared to placebo in patients with DHF. A total of 70 patients with DHF will be randomized in a 1:1 ratio to:
- placebo (n=35) or to
- clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by uptitration to 0.150 mg twice a day for 6 months.
The primary outcome is the reversion of cardiac remodeling and hemodynamic parameters evaluated by magnetic resonance imaging (MRI) and echocardiography.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 60 and greater
- Gender: Both
- Patients with heart failure New York Heart Association (NYHA) II and ejection fraction over 45%
Key exclusion criteria (0 listed)
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 withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2007.
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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.
Pascal Bousquet, MD principal investigator
Hopitaux Universitaires de Strasbourg
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Dysfunction, run by University Hospital, Strasbourg, France.
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 3 inclusion and 0 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: withdrawn, as of the sponsor's last update on 29 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 29 Nov 2007.