Chronic Heart Failure
Conditions
Keywords
Chronic Heart Failure, Heart Disease
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.
Interventions
DRUGVasopressin V2 Receptor Antagonist
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical status at day 120. | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration. | — |
Countries
Canada, United Kingdom, United States
Outcome results
None listed