Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure

NCT01618448 | Completed Phase 3

• 1 other identifier: 156-TWA-1101
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac-induced Edema

Outcome Measures

Primary Outcomes (1)

• Change in body weight at 4-day of treatment.

  baseline and 4-day of treatment

Secondary Outcomes (7)

• 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

Study Arms (2)

Placebo

EXPERIMENTAL

Placebo once daily

Drug: Placebo

Tolvaptan

EXPERIMENTAL

Tolvaptan 15mg once daily

Drug: Tolvaptan

Interventions

Tolvaptan DRUG

Tolvaptan 15mg once daily

Also known as: Samsca

Tolvaptan

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with history of chronic HF hospitalized primarily for worsening HF with signs or symptoms of volume congestion in spite of standard therapy 3. 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 4. 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 5. Patients who had been taking an orally administered diuretic without any change in dose or mode of administration during Observation period 6. Patients whose body weight variation was within 1.0 kg during the 2 days prior start of treatment 7. Patients able to accomplish with study procedures from Screening period to Post-study follow-up 8. Patients capable of giving informed consent to participate in the study of their own free will.

You may not qualify if:

• 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)
• Patients with a definite diagnosis of active myocarditis or amyloid cardiomyopathy
• Poorly controlled Diabetes Mellitus (HbAlc 10%)
• Anuria (urinary output less than 100 ml per day)
• History of Hyperthyroidism
• Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause

Sponsors & Collaborators

• Taiwan Otsuka Pharm. Co., Ltd: lead

Study Sites (1)

National Taiwan University Hospita

Taipei, Taiwan

Location

MeSH Terms

Conditions

Edema, Cardiac

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Edema; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chuen-Den Tseng

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 13, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 2, 2015

Record last verified: 2013-01

Locations

TW (1)