Back to resultsInterleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)
Primary Purpose
Heart Failure, Systolic, Renal Disease, End Stage, Chronic Kidney Diseases
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anakinra
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Heart failure, End-stage renal disease, Interleukin-1, Interleukin-1 receptor antagonist, Metabolomics, Lipidomics, Chronic kidney disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active Treatment
Arm Description
Anakinra (Kineret)
Outcomes
Primary Outcome Measures
Peak oxygen consumption (PVO2)
Peak oxygen consumption during cardiopulmonary exercise
Secondary Outcome Measures
Heart Failure Hospitalization
Number of participants with a hospitalization for heart failure during the 6 months of treatment
Full Information
NCT ID
NCT03062176
First Posted
January 25, 2017
Last Updated
May 15, 2019
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03062176
Brief Title
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease
Acronym
E-HART
Official Title
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
We screened over 200 patients but were ultimately unable to enroll anyone
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic, Renal Disease, End Stage, Chronic Kidney Diseases
Keywords
Heart failure, End-stage renal disease, Interleukin-1, Interleukin-1 receptor antagonist, Metabolomics, Lipidomics, Chronic kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Anakinra (Kineret)
Intervention Type
Drug
Intervention Name(s)
Anakinra
Other Intervention Name(s)
Kineret
Intervention Description
Anakinra (Kineret)
Primary Outcome Measure Information:
Title
Peak oxygen consumption (PVO2)
Description
Peak oxygen consumption during cardiopulmonary exercise
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Heart Failure Hospitalization
Description
Number of participants with a hospitalization for heart failure during the 6 months of treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin W Van Tassell, PharmD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease
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