Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00032747
First received: March 29, 2002
Last updated: June 16, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Chronic Heart Failure
Drug: Vasopressin V2 Receptor Antagonist
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Clinical status at day 120.

Secondary Outcome Measures:
  • NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.

Enrollment: 338
Study Start Date: August 2001
Study Completion Date: February 2003
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032747

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242-1081
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Nebraska
Brian LGH Heart Institute
Lincoln, Nebraska, United States, 68510
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
United States, South Carolina
MUSC/Division Cardiology
Charleston, South Carolina, United States, 29425
Canada
Sanofi-aventis Administrative Office
Laval, Canada
United Kingdom
Sanofi-aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00032747     History of Changes
Other Study ID Numbers: DFI4510, SR121463B
Study First Received: March 29, 2002
Last Updated: June 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Chronic Heart Failure
Heart Disease

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014