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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Chronic Heart Failure

Treatments

Drug: Vasopressin V2 Receptor Antagonist

Study type

Interventional

Funder types

Industry

Identifiers

NCT00032747

SR121463B

DFI4510

Details and patient eligibility

About

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.

Enrollment

338 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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