MedTrace Logo

Interleukin-1 Blockade in Recently Decompensated Heart Failure

NCT01936909 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-12-22

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Anakinra (weeks 1-2)

Anakinra 100 mg daily for weeks 1 and 2

DRUG

Anakinra (weeks 3-12)

DRUG

Placebo

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Antonio Abbate, MD, PhD · Virginia Commonwealth University

  • Benjamin W Van Tassell, PharmD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-09-23
Completion
2016-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01936909 on ClinicalTrials.gov