Chronic Heart FailurePhase 2NCT00032747
Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).
A Phase 2 study testing Vasopressin V2 Receptor Antagonist in people with Chronic Heart Failure, run by Sanofi at 9 sites in 3 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and <137 mmol/L). 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?
- Vasopressin V2 Receptor Antagonist
- How many people
- 338 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Aug 2001to Feb 2003
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Men or women with chronic heart failure (NYHA Class IIIB and IV).
- Women must be post-menopausal or surgically sterilized; they cannot be pregnant or nursing.
- Age 21 to 80 years.
- Chronic heart failure of at least 3 months duration. For 2 months prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 50% of the time. For 2 weeks prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 90% of the time.
- Patients must be receiving a diuretic and an ACE inhibitor (or an angiotensin II receptor antagonist) for the treatment of heart failure.
- Patients may be receiving digoxin, a beta-blocker or spironolactone
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites
Emory University
Atlanta, Georgia, 30322
University of Maryland School of Medicine
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294
MUSC/Division Cardiology
Charleston, South Carolina, 29425
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242-1081
Brian LGH Heart Institute
Lincoln, Nebraska, 68510
United Kingdom1 site
Sanofi-aventis Administrative Office
Guildford Surrey
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Effects of Vasopressin V2 Receptor Antagonist on Clinical Improvement in Patients With Severe Chronic Heart Failure
This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.
- Conditions
- Chronic Heart Failure
- Being tested
- Vasopressin V2 Receptor Antagonist
- Keywords
- Chronic Heart Failure, Heart Disease
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressin V2 Receptor AntagonistDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical status at day 120.
Secondary outcomes (1)
NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2002 (estimated)
- Study startAug 2001
- Study completionFeb 2003
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 SanofiThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032747
- Sponsor's protocol ID
- DFI4510
- Other IDs
- SR121463B
- Status last verified
- Jun 2008
- First submitted
- 29 Mar 2002
- Last updated
- 17 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Effects of Vasopressin V2 Receptor Antagonist on Clinical Improvement in Patients With Severe Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00032747
- Acronym / sponsor ID
- DFI4510
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic Heart Failure, Heart Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Study completion
- Feb 2003 (actual)
- First posted
- 1 Apr 2002 (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.
This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Vasopressin V2 Receptor Antagonist | Drug | – |
Primary outcome
Clinical status at day 120.
1 secondary outcome
NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.
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 17 Jun 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
ICD CSD study director
Sanofi
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vasopressin V2 Receptor Antagonist in people with Chronic Heart Failure, run by Sanofi at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, 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. 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 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?
Clinical status at day 120.. It is what the study was designed to measure, not a finding.
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 Jun 2008.