Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease

Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03062176

Acronym

E-HART

Enrollment

Registered

2017-02-23

Start date

2017-04-03

Completion date

2019-05-15

Last updated

2019-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Heart Failure, Systolic, Renal Disease, End Stage

Keywords

Heart failure, End-stage renal disease, Interleukin-1, Interleukin-1 receptor antagonist, Metabolomics, Lipidomics, Chronic kidney disease

Brief summary

Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with advanced chronic kidney disease and heart failure.

Interventions

DRUGAnakinra

Anakinra (Kineret)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Written informed consent * 18 years or older * Chronic heart failure * Left ventricular ejection fraction less than 50% * C-reactive protein greater than or equal to 2 mg/L * Maintenance hemodialysis with a biocompatible membrane, acceptable dialysis adequacy (Kt/V \> 1.2), and receipt of a stable hemodialysis prescription for at least 4 weeks OR chronic kidney disease stage IV/V (estimated glomerular filtration rate \<30 mL/min/1.73m2)

Exclusion criteria

* Inability to complete maximal cardiopulmonary exercise testing * Need for urgent or emergent care * Recent use of immunosuppressant, anti-inflammatory therapies or active rheumatologic disease * Allergy to rubber, latex, Escherichia coli or anakinra

Design outcomes

Primary

Measure	Time frame	Description
Peak oxygen consumption (PVO2)	6 months	Peak oxygen consumption during cardiopulmonary exercise

Secondary

Measure	Time frame	Description
Heart Failure Hospitalization	6 months	Number of participants with a hospitalization for heart failure during the 6 months of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026