Heart Failure Clinical Trial

AiDing Diuresis wIth Tolvaptan (ADD-IT)

Summary

The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. The investigators are looking to see if there is improvement in the symptoms and outcomes of persons with acute heart failure.

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Full Description

This is a single-center, randomized trial to assess the effects of 30 mg daily of tolvaptan when given concomitantly with home dose of diuretic (Lasix equivalent) intravenously (IV) versus 5mg daily of metolazone given concomitantly with home dose of diuretic (Lasix equivalent) IV, versus 2.5 times home dose of diuretic (Lasix equivalent) IV in participants hospitalized for acutely decompensated heart failure (ADHF).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants hospitalized for worsening acute heart failure and randomized within 36 hours of initial presentation
New York Heart Association (NYHA) Class III or IV on admission to the hospital with at least 1 month history of treated heart failure
Able to understand content of and willing to provide written informed consent

The participant must have signs of extracellular volume expansion, defined as two or more of the following four signs or symptoms:

signs of RHF (right heart failure) (jugular venous distention, pitting edema, or (≥1+), ascites and/or signs of LHF (left heart failure) (pulmonary congestion on chest x-ray, pulmonary rales)
Brain Natriuretic Peptide (BNP) > 450
serum sodium < 140 mEq/L

Exclusion Criteria:

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, defined as 3x upper limit of normal (ULN)
Chronic uncontrolled diabetes mellitus with Hemoglobin A1C > 10%
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

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

14

Study ID:

NCT02646540

Recruitment Status:

Completed

Sponsor:

Emory University

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There are 2 Locations for this study

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Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Emory University Hospital
Atlanta Georgia, 30322, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

14

Study ID:

NCT02646540

Recruitment Status:

Completed

Sponsor:


Emory University

How clear is this clinincal trial information?

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