Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure

Completed · Phase 3 · Has a placebo group

Conditions studied: Heart Failure, Dyspnea

In brief

The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be more effective at relieving dyspnea than fixed dose furosemide alone

Key facts

Study ID

NCT01644331

Run by

Duke University

People needed

257

Starts

2012-10-01

Expected to finish

2016-02-01

Last updated by the study team

2017-04-27

Who can join

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

You may qualify if…

• ≥ 18 years of age
• Daily oral dose of furosemide between ≥ 40 mg(or equivalent)
• Identified within 24 hours of presentation, defined for purposes of this study as the time of initial dose of intravenous loop diuretic
• Prior clinical HF diagnosis that was treated with oral loop diuretics for at least 1 month
• Admission for acute decompensated Heart Failure (HF) as determined by
• dyspnea at rest or with minimal exertion
• Brain Natriuretic Peptide (BNP) > 400 or NTproBNP > 2000 pg/mL
• AND at least one of the following additional signs and symptoms:
• Orthopnea
• Peripheral edema
• Elevated JVP (Jugular Venous Pressure)
• Pulmonary rales
• Congestion on Chest X-ray
• No plan for revascularization, cardiac transplant, of ventricular assist device implantation, or other cardiac surgery within 60 days of randomization
• Signed informed consent

You may not qualify if…

• Serum Na > 140 meq/L
• Received IV vasoactive treatment or ultra-filtration therapy for HF since initial presentation
• Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for HF
• Systolic Blood Pressure (SBP)<90mmHg
• Serum-Cr>3.5mg/dl or currently undergoing renal replacement therapy
• . Known underlying liver disease
• Hemodynamically significant arrhythmias
• ACS(Acute coronary syndrome) within 4 weeks prior to study entry
• Active myocarditis
• Hypertrophic obstructive, restrictive, constrictive cardiomyopathy
• Severe stenotic valvular disease
• Complex congenital heart disease
• Constrictive pericarditis
• Clinical evidence of digoxin toxicity
• Need for mechanical hemodynamic support
• Terminal illness (other than heart failure) with expected survival time of less than 1 year
• History of adverse reaction to Tolvaptan
• Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
• Pregnant or breast-feeding
• Inability to comply with planned study procedures

Where it is running

• University of Colorado at Denver and Health Sciences Center — Aurora, Colorado, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Northeast Georgia Heart Center — Gainesville, Georgia, United States
• Mercer University School of Medicine — Macon, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Novant Health Heart and Vascular — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Southeastern Regional Medical Center — Lumberton, North Carolina, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Allegheny Valley Hospital — Natrona Heights, Pennsylvania, United States
• Grand View - Lehigh Valley Health Services — Sellersville, Pennsylvania, United States
• UT Southwestern Medical center — Dallas, Texas, United States
• Inova Heart and Vascular Institute — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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