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

Completed · Phase 3 · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01584557

Run by

Cardiovascular Clinical Sciences Inc

People needed

250

Starts

2012-06-01

Expected to finish

2016-08-01

Last updated by the study team

2016-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects hospitalized for worsening heart failure and randomized within 36 hours of initial presentation.
• Males and females 18 years of age or older.
• NYHA Class III or IV on admission to the hospital.
• Able to understand content of and willing to provide written informed consent
• 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.
• 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)
• Have at least one of the following:
• eGFR < 60ml/min/1.73m2, OR
• serum sodium ≤ 134 mEq/L, OR
• urine output ≤ 125 ml/hr over anytime frame of at least 2 hours, following administration of IV furosemide of at least 40mg. See table below.
• Time Period (hr) Cumulative UO (mL) 2 <250 3 <375 4 <500 5 <625 6 <750 7 <875 8 <1000

You may not qualify if…

• Positive urine pregnancy test for women of child bearing potential.
• Inability to provide written informed consent.
• Cardiac surgery within 60 days prior to study randomization.
• Acute Coronary Syndrome (ACS) or percutaneous coronary intervention within 30 days prior to study randomization.
• Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
• Planned electrophysiologic (EP) device implantation within 7 days following study randomization.
• Subjects who are on cardiac mechanical support.
• Co-morbid condition with an expected survival less than six months.
• History of a cerebrovascular accident within the last 30 days.
• Hemodynamically significant uncorrected primary cardiac valvular disease.
• Hypertrophic cardiomyopathy (obstructive or non-obstructive).
• Uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
• History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
• Chronic uncontrolled diabetes mellitus as determined by the investigator.
• Supine systolic arterial blood pressure < 90 mmHg.
• Serum creatinine > 3.5 mg/dL or undergoing dialysis.
• Hemoglobin < 9 g/dL
• History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazepril).
• Inability to take oral medications.
• Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted.
• Previous exposure to tolvaptan within 7 days prior to randomization.
• Subjects with refractory, end-stage, heart failure defined as subjects who are appropriate candidates for specialized treatment strategies, such as ventricular assist devices, continuous positive IV inotropic therapy, or hospice care.
• Ultrafiltration within 7 days prior to randomization or planned.
• Active gout
• Serum sodium >144 mEq/L

Where it is running

• 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
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• St. Vincent Medical Group — Indianapolis, Indiana, United States
• CardioSpecialists Group — Munster, Indiana, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Advanced Cardiovascular Specialists — Shreveport, Louisiana, United States
• Louisiana Heart Center and Research — Slidell, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• Crittenton Hospital Medical Center — Rochester, Michigan, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Bryan Heart Institute — Lincoln, Nebraska, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• Caromont Heart/Gaston Memorial Hospital — Gastonia, North Carolina, United States
• Duke Cardiology of Lumberton Research/Southeastern Regional Medical Cente — Lumberton, North Carolina, United States

Full record on ClinicalTrials.gov

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