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

Chronic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032747
• Other study ID #: DFI4510
• Secondary ID: SR121463B
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2002
• Last updated: June 16, 2008
• Start date: August 2001
• Est. completion date: February 2003

Study information

• Verified date: June 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Vasopressin V2 Receptor Antagonist

Locations

Country	Name	City	State
Canada	Sanofi-aventis Administrative Office	Laval
United Kingdom	Sanofi-aventis Administrative Office	Guildford Surrey
United States	Emory University	Atlanta	Georgia
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	MUSC/Division Cardiology	Charleston	South Carolina
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa
United States	Brian LGH Heart Institute	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical status at day 120.
Secondary	NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.

External Links

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