Interleukin-1 Blockade in Recently Decompensated Heart Failure

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01936909

Run by

Virginia Commonwealth University

People needed

60

Starts

2014-02-01

Expected to finish

2016-09-23

Last updated by the study team

2017-12-22

Who can join

Age: 21 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All 6 criteria need to be met for enrollment of the patient in the study
• Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below:
• dyspnea or respiratory distress or tachypnea at rest or with minimal exertion;
• evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met);
• pulmonary congestion/edema at physical exam OR chest X-Ray;
• plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/ml;
• invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
• The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months).
• The patient is now clinically stable and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:
• absence of dyspnea or pulmonary congestion/distress at rest;
• absence of pitting edema in the lower extremities, or in any other region;
• stable hemodynamic parameters (blood pressure, heart rate).
• The patient is of age ≥21 years old, and is willing and able to provide written informed consent.
• The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).
• The patient has screening plasma C-reactive protein levels >2 mg/L.
• Exclusion Criteria Subjects will not be eligible if they meet any of the following 15 exclusion criteria.
• The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
• Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration.
• Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries.
• Previous or planned implantation of left ventricular assist devices or heart-transplant.
• Chronic use of intravenous inotropes.
• Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]).
• Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).
• Active infection (of any type);
• Chronic/recurrent infectious disease (including Hepatitis B virus [HBV], Hepatitis C virus [HCV], and HIV/AIDS).

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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