CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Anakinra (weeks 1-2) +2 moredrug
Likely dose
Anakinra (weeks 1-2) 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01936909
NCT01936909Phase 3Completed
CompareCT.gov

Interleukin-1 Blockade in Recently Decompensated Heart Failure: A Randomized Placebo-controlled Double-blinded Study

Virginia Commonwealth University·interventional·Posted Sep 6, 2013·Updated Dec 22, 2017

In Brief

A Phase 3 clinical trial evaluating Anakinra (weeks 1-2), Anakinra (weeks 3-12), and 1 other intervention for Heart Failure. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 6, 2013
Enrollment StartFeb 1, 2014
Primary CompletionSep 23, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.8 years ago

Interventions

Anakinra (weeks 1-2)drug

Anakinra 100 mg daily for weeks 1 and 2

Anakinra (weeks 3-12)drug

Placebodrug