A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure

Taiwan Otsuka Pharm. Co., Ltd1 site in 1 country85 target enrollmentJuly 2012

ConditionsCardiac-induced Edema

InterventionsPlacebo Tolvaptan

DrugsTolvaptan Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Cardiac-induced Edema
Sponsor: Taiwan Otsuka Pharm. Co., Ltd
Enrollment: 85
Locations: 1
Primary Endpoint: Change in body weight at 4-day of treatment.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients with Heart Failure

Detailed Description

Interventional, phase III, 2-arm parallel group, placebo-controlled, multicenter, randomized 1:1, double-blind study, comparing Tolvaptan and placebo in hospitalized HF patients with signs or symptoms of congestion at the time of randomization in spite of standard therapy.This study intends to demonstrate that a repeated 4-day treatment with Tolvaptan in addition to standard of care (SOC) is superior to SOC alone for the treatment of clinical relevant cardiac-induced volume retention parameters in patients hospitalized for worsening HF initially treated with conventional therapy including diuretics.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

December 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taiwan Otsuka Pharm. Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with history of chronic HF hospitalized primarily for worsening HF with signs or symptoms of volume congestion in spite of standard therapy
•Patient should have HF symptoms at rest or minimal exertion and signs of congestion (lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion) at time of randomization c. Anti-aldosterone drugs: Spironolactone, Triamterene
•Patients undergoing any of the following diuretic therapies:
•A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide
•Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses)
•Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses)
•Note: The allowable types and dosages of the concomitantly administered diuretics are specified as follows:
•Loop diuretics equivalent to 40 mg of furosemide:
•Bumetanide: 1 mg, Piretanide: 6 mg, Azosemide: 60 mg, Torasemide: 8 mg
•Thiazide diuretics: Hydrochlorothiazide, Trichloromethiazide, Benzyl hydrochlorothiazide, Chlortalidone, Mefruside

Exclusion Criteria

•Cardiac surgery within 60 days of enrollment
•Patients with an assisted cardiac mechanical device
•Patients receiving CRT (Cardiac Resynchronization Therapy) within 60 days of enrollment.
•Patients with active or significant complications or symptoms as follow:
•Suspected decrease in circulatory blood flow
•Refractory end-stage HF (patients considered to require mechanical circulatory support, continuous intravenous positive inotropic therapy, referral of cardiac transplantation, or hospice care)
•Cardiac valvular disease with significant heart valve stenosis
•Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to screening examination
•Acute myocardial infarction within 30 days prior to screening examination
•Cerebrovascular disorders within 6 months prior to screening examination (other than asymptomatic cerebral infarction)

Arms & Interventions

Placebo

Placebo once daily

Intervention: Placebo

Tolvaptan

Tolvaptan 15mg once daily

Intervention: Tolvaptan

Outcomes

Primary Outcomes

Change in body weight at 4-day of treatment.

Time Frame: baseline and 4-day of treatment

Secondary Outcomes

Change in Intake/Output Balance at 4-day of Treatment(baseline and 4-day of treatment)
Change in Serum Sodium and Potassium Concentration at 4-day of treatment(baseline and 4-day of treatment)
Treatment Failure at 4-day of Treatment(baseline and 4-day of treatment)
Changes in Physician-assessed Signs and Symptoms of Heart Failure at 4-day of Treatment(baseline and 4-day of treatment)
Changes in Patient Self-assessed Global Clinical Status at 4-day of Treatment(baseline and 4-day of treatment)
Changes in Patient Self-assessed Dyspnea Status at 4-day of Treatment(baseline and 4-day of treatment)
All-cause Mortality during the Study Period(Duration of hospital stay for 4 days, post-study follow up visit for 2 times)