Back to resultsSafety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vasopressin V2 Receptor Antagonist
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Heart Disease
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham
- Emory University
- University of Iowa Hospital and Clinics
- University of Maryland School of Medicine
- Brian LGH Heart Institute
- The Lindner Clinical Trial Center
- MUSC/Division Cardiology
- Sanofi-aventis Administrative Office
- Sanofi-aventis Administrative Office
Outcomes
Primary Outcome Measures
Clinical status at day 120.
Secondary Outcome Measures
NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00032747
Brief Title
Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Chronic Heart Failure, Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vasopressin V2 Receptor Antagonist
Primary Outcome Measure Information:
Title
Clinical status at day 120.
Secondary Outcome Measure Information:
Title
NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1081
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brian LGH Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
MUSC/Division Cardiology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sanofi-aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-aventis Administrative Office
City
Guildford Surrey
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.centerwatch.com
Description
Related Info
URL
http://www.sanofi-aventis.com
Description
Related Info
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Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).
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