Congestive Heart Failure Clinical Trial
Official title:
Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Efficacy and Safety Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure
The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients with congestive heart failure.
Diuretics are used extensively in the treatment of patients with CHF, and their efficacy is
well established. However, there is a tendency for currently used diuretics to increase
afterload and deplete electrolytes, and in many patients ventricular function continues to
deteriorate over time.
Loop diuretics, such as furosemide, also have known negative effects on renal function
reducing the glomerular filtration rate, and have been shown to activate the RAA system.
Lixivaptan is a potent, non-peptide selective antagonist of the vasopressin V2 receptor.
Lixivaptan treatment results in increased free water excretion, thus decreasing urine
osmolality, increasing urine flow, and increasing serum osmolality. Short-term treatment
with lixivaptan has demonstrated improved fluid management and electrolyte balance in HF
patients.
This study was designed to assess the effects of vasopressin blockade with lixivaptan in
patients with CHF with volume overload. A placebo-control arm will allow for assessment of
the effect of lixivaptan in addition to standard diuretic therapy as compared with standard
diuretic therapy alone.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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