Interleukin-1 Blockade in Recently Decompensated Heart Failure

NCT01936909 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: RED-HART (HM15339)1R34HL117026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Interval Changes in Peak Oxygen Consumption (VO2)

  Interval changes in peak oxygen consumption (VO2) after 2 weeks of anakinra treatment.

  Baseline to 2 weeks

Secondary Outcomes (2)

• Quality of Life Improvement

  12 weeks

• Death or Hospital Admission for Heart Failure

  24 weeks

Study Arms (3)

Anakinra (short)

EXPERIMENTAL

Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks

Drug: Anakinra (weeks 1-2)

Anakinra (long)

EXPERIMENTAL

Anakinra 100 mg daily for 12 weeks

Drug: Anakinra (weeks 1-2); Drug: Anakinra (weeks 3-12)

Placebo

PLACEBO COMPARATOR

Placebo injections daily for 12 weeks

Drug: Placebo

Interventions

Anakinra (weeks 1-2) DRUG

Anakinra 100 mg daily for weeks 1 and 2

Anakinra (long); Anakinra (short)

Anakinra (weeks 3-12) DRUG

Also known as: Anakinra 100 mg daily for weeks 3 through 12

Anakinra (long)

Placebo DRUG

Also known as: Placebo daily for week 1 through 12

Placebo

Eligibility Criteria

• Age: 21 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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).
• Prior (within the past 10 years) or current malignancy.
• Any comorbidity limiting survival or ability to complete the study.
• End stage kidney disease requiring renal replacement therapy.
• Neutropenia (\<2,000/mm3) or Thrombocytopenia (\<50,000/mm3).
• Pregnancy.
• Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• Van Tassell BW, Canada J, Carbone S, Trankle C, Buckley L, Oddi Erdle C, Abouzaki NA, Dixon D, Kadariya D, Christopher S, Schatz A, Regan J, Viscusi M, Del Buono M, Melchior R, Mankad P, Lu J, Sculthorpe R, Biondi-Zoccai G, Lesnefsky E, Arena R, Abbate A. Interleukin-1 Blockade in Recently Decompensated Systolic Heart Failure: Results From REDHART (Recently Decompensated Heart Failure Anakinra Response Trial). Circ Heart Fail. 2017 Nov;10(11):e004373. doi: 10.1161/CIRCHEARTFAILURE.117.004373.

  PMID: 29141858 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Benjamin Van Tassell
• Organization: Virginia Commonwealth University

bvantassell@vcu.edu

8048284583

Study Officials

• Antonio Abbate, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Benjamin W Van Tassell, PharmD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: February 1, 2014
• Primary Completion: September 23, 2016
• Study Completion: September 23, 2016
• Last Updated: December 22, 2017
• Results First Posted: December 22, 2017

Record last verified: 2017-11

Locations

US (1)