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Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure

NCT01644331 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2017-04-27

Study results available
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Summary

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

Conditions

Interventions

DRUG

Tolvaptan

IV furosemide plusTolvaptan (given at 0, 24 and 48 hours)

DRUG

Placebo

IV furosemide plus oral placebo (given at 0, 24 and 48 hours)

Sponsors & Collaborators

Principal Investigators

  • Michael Felker, MD · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01644331 on ClinicalTrials.gov