Study Summary
This trial is testing whether the drug Anakinra can help improve the exercise capacity of patients with heart failure and inflammation.
Eligible Conditions
- Heart Failure
- Inflammation
- Systolic Heart Failure
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: baseline - 24 weeks
baseline - 24 weeks
Biomarker - N-terminal pro b-type Natriuretic Peptide (NT-proBNP)
Biomarker - high sensitivity C-reactive protein (CRP)
Clinical Outcome - cardiac death
Clinical Outcome - hospitalization for heart failure
Quality of Life Assessments
changes in peak oxygen consumption (VO2)
echocardiography assessments
hemodynamic assessments
Week 12
changes in peak VO2 at earlier endpoints
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
anakinra
1 of 2
placebo
1 of 2
Experimental Treatment
Non-Treatment Group
102 Total Participants · 2 Treatment Groups
Primary Treatment: Anakinra · Has Placebo Group · Phase 2
anakinra
Drug
Experimental Group · 1 Intervention: Anakinra · Intervention Types: Drugplacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline - 24 weeks
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
625 Previous Clinical Trials
365,670 Total Patients Enrolled
4 Trials studying Inflammation
46 Patients Enrolled for Inflammation
Antonio Abbate, MD, PhDPrincipal InvestigatorVirginia Commonwealth University
13 Previous Clinical Trials
408 Total Patients Enrolled
3 Trials studying Inflammation
27 Patients Enrolled for Inflammation
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a stable hemodynamic parameters.
References
- Sedhai, Yub Raj, Nimesh K. Patel, Virginia Mihalick, Azita Talasaz, Georgia Thomas, Bethany L. Denlinger, Juan I. Damonte, et al.. 2022. “Heart Failure Clinical Trial Enrollment at a Rural Satellite Hospital”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106731.
- Sedhai, Yub Raj, Nimesh K. Patel, Virginia Mihalick, Azita Talasaz, Georgia Thomas, Bethany L. Denlinger, Juan I. Damonte, et al.. 2022. “Heart Failure Clinical Trial Enrollment at a Rural Satellite Hospital”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106731.
- Van Tassell, Benjamin, Virginia Mihalick, Georgia Thomas, Amr Marawan, Azita H. Talasaz, Juan Lu, Le Kang, et al.. 2022. “Rationale and Design of Interleukin-1 Blockade in Recently Decompensated Heart Failure (REDHART2): A Randomized, Double Blind, Placebo Controlled, Single Center, Phase 2 Study”. Journal of Translational Medicine. Springer Science and Business Media LLC. doi:10.1186/s12967-022-03466-9.
- 2019. "Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03797001.
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Conditions
Cancer Related
Treatments