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Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management

A Phase 3 Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management

NCT01584557•Cardiovascular Clinical Sciences Inc

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8 and 16 hours.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects hospitalized for worsening heart failure and randomized within 36 hours of initial presentation.
•2. Males and females 18 years of age or older.
•3. NYHA Class III or IV on admission to the hospital.
•4. Able to understand content of and willing to provide written informed consent
•5. Dyspnea, measured by the 5-point current dyspnea scale (moderately short of breath or worse), within 2 hours of randomization and dosing.
•The following must be met within 12 hours of randomization.
•6. The subject must have signs of extracellular volume expansion, defined as two or more of the following five: Signs of RHF ( jugular venous distention, pitting edema (≥1+), ascites) and/or Signs of LHF (pulmonary congestion on chest x-ray, pulmonary rales)
•7. Have at least one of the following:
•* eGFR \< 60ml/min/1.73m2, OR
•* serum sodium ≤ 134 mEq/L, OR
+2 more criteria

Exclusion Criteria

•1. Positive urine pregnancy test for women of child bearing potential.
•2. Inability to provide written informed consent.
•3. Cardiac surgery within 60 days prior to study randomization.
•4. Acute Coronary Syndrome (ACS) or percutaneous coronary intervention within 30 days prior to study randomization.
•5. Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
•6. Planned electrophysiologic (EP) device implantation within 7 days following study randomization.
•7. Subjects who are on cardiac mechanical support.
•8. Co-morbid condition with an expected survival less than six months.
•9. History of a cerebrovascular accident within the last 30 days.
•10. Hemodynamically significant uncorrected primary cardiac valvular disease.
+15 more criteria

Locations (37)

University of Alabama at Birmingham

Birmingham, Alabama, United States

The Heart Center Research

Huntsville, Alabama, United States

Greater Los Angeles VA Medical Center

Los Angeles, California, United States

University of Florida Health Science Ctr. Jacksonville

Jacksonville, Florida, United States

MIMA Century Research Associates

Melbourne, Florida, United States

Jackson Memorial Hospital

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

University Cardiology Associates, LLC

Augusta, Georgia, United States

Mercer University School of Medicine

Macon, Georgia, United States

Advocate Medical Group - Oakbrook

Naperville, Illinois, United States

Key Dates

Start Date

June 1, 2012

Primary Completion Date

July 1, 2016

Completion Date

August 1, 2016

Last Updated

September 27, 2016

Enrollment

250

ACTUAL participants

Conditions

Heart Failure

Interventions

Tolvaptan or Samsca

DRUG

placebo or sugar pill

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management

Inclusion Criteria

Exclusion Criteria

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