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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
| Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
| Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
| Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
| Completed |
NCT04037436 -
Functional Exercise and Nutrition Education Program for Older Adults
|
N/A | |
| Recruiting |
NCT04703842 -
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
|
Phase 1/Phase 2 | |
| Terminated |
NCT05594940 -
Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
|
||
| Recruiting |
NCT04982081 -
Treating Congestive HF With hiPSC-CMs Through Endocardial Injection
|
Phase 1 | |
| Completed |
NCT04394754 -
Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure
|
N/A | |
| Active, not recruiting |
NCT01385176 -
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
|
N/A | |
| Not yet recruiting |
NCT05516290 -
Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
|
||
| Terminated |
NCT02788656 -
Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan)
|
Phase 4 | |
| Completed |
NCT02885636 -
Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial
|
Phase 3 | |
| Completed |
NCT02252757 -
Assess Measurements of Wireless Cardiac Output Device
|
N/A | |
| Terminated |
NCT02205411 -
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
|
N/A | |
| Completed |
NCT01362855 -
Advance Care Planning Evaluation in Hospitalized Elderly Patients
|
||
| Withdrawn |
NCT00346177 -
Stem Cell Study for Patients With Heart Failure
|
Phase 2 | |
| Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
| Active, not recruiting |
NCT01058837 -
SCD-HeFT 10 Year Follow-up
|
N/A | |
| Completed |
NCT00957541 -
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
|
Phase 2 |