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Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure

NCT01863511 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-01-28

No results posted yet for this study

Summary

For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal, less neurohormonal stimulation and greater sodium removal.However it is associated with increased costs, line complications, and relative immobility during treatment. Tolvaptan in addition to diuretic therapy has been shown to improve the amount of volume removed compared to diuretic alone.

The study proposes to compare the strategy of adding tolvaptan to usual care with ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients.

Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in:

* greater volume and weight reduction compared with usual care
* similar efficacy outcomes compared with ultrafiltration, with less complications of therapy

Conditions

  • Acute Decompensated Heart Failure

Interventions

DRUG

loop diuretic

DRUG

tolvaptan

PROCEDURE

ultrafiltration

Sponsors & Collaborators

  • The Christ Hospital

    lead OTHER

Principal Investigators

  • Eugene S Chung, MD · The Christ Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01863511 on ClinicalTrials.gov