Brief Summary

Heart failure remains a major cause of morbidity and mortality. Many patients with heart failure receive support from a left ventricular assist device (LVAD) at some point in the course of their disease. Some of these LVAD patients experience a durable recovery after ventricular unloading with an LVAD, which may be associated with inhibition of inflammatory cytokines. This small pilot study aims to determine the biologic and clinical efficacy of an interleukin-1 receptor antagonist (Anakinra) at inducing myocardial recovery in patients supported with left ventricular assist devices.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1 heart-failure

Timeline

Completed

Started Apr 2015

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

April 1, 2015

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

3.2 years until next milestone

Results Posted

Study results publicly available

February 17, 2020

Completed

Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

September 9, 2015

Results QC Date

June 11, 2018

Last Update Submit

February 3, 2020

Conditions

Heart Failure

Keywords

Ventricular Assist DeviceRecovery of Function

Outcome Measures

Primary Outcomes (1)

Biologic Efficacy: Inflammation Marker - C-Reactive Protein
The primary endpoint was a reduction in inflammatory markers, specifically C-reactive protein (CRP).
6 months post treatment

Secondary Outcomes (3)

Biologic Efficacy: Inflammation Marker - Neutrophil Count
6 months post treatment
Clinical Efficacy: Ejection Fraction
6 months post treatment
Biologic Efficacy: Inflammation Marker - TNFalpha
6 months post treatment

Study Arms (1)

Anakinra Arm

EXPERIMENTAL

All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect.

Drug: Anakinra

Interventions

AnakinraDRUG

Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days.

Also known as: Kineret

Anakinra Arm

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

They must also be judged by the implanting surgeon to have an expected survival to trial completion (approximately 6 months after implantation), without regard to the likelihood of cardiac transplantation.

You may not qualify if:

Last, any patient with dependence on inflammatory modulating drugs will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Utahlead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (7)

Birks EJ, Tansley PD, Hardy J, George RS, Bowles CT, Burke M, Banner NR, Khaghani A, Yacoub MH. Left ventricular assist device and drug therapy for the reversal of heart failure. N Engl J Med. 2006 Nov 2;355(18):1873-84. doi: 10.1056/NEJMoa053063.
PMID: 17079761BACKGROUND
Abbate A, Van Tassell BW, Biondi-Zoccai G, Kontos MC, Grizzard JD, Spillman DW, Oddi C, Roberts CS, Melchior RD, Mueller GH, Abouzaki NA, Rengel LR, Varma A, Gambill ML, Falcao RA, Voelkel NF, Dinarello CA, Vetrovec GW. Effects of interleukin-1 blockade with anakinra on adverse cardiac remodeling and heart failure after acute myocardial infarction [from the Virginia Commonwealth University-Anakinra Remodeling Trial (2) (VCU-ART2) pilot study]. Am J Cardiol. 2013 May 15;111(10):1394-400. doi: 10.1016/j.amjcard.2013.01.287. Epub 2013 Feb 27.
PMID: 23453459BACKGROUND
Abbate A, Kontos MC, Grizzard JD, Biondi-Zoccai GG, Van Tassell BW, Robati R, Roach LM, Arena RA, Roberts CS, Varma A, Gelwix CC, Salloum FN, Hastillo A, Dinarello CA, Vetrovec GW; VCU-ART Investigators. Interleukin-1 blockade with anakinra to prevent adverse cardiac remodeling after acute myocardial infarction (Virginia Commonwealth University Anakinra Remodeling Trial [VCU-ART] Pilot study). Am J Cardiol. 2010 May 15;105(10):1371-1377.e1. doi: 10.1016/j.amjcard.2009.12.059. Epub 2010 Apr 2.
PMID: 20451681BACKGROUND
Drakos SG, Wever-Pinzon O, Selzman CH, Gilbert EM, Alharethi R, Reid BB, Saidi A, Diakos NA, Stoker S, Davis ES, Movsesian M, Li DY, Stehlik J, Kfoury AG; UCAR (Utah Cardiac Recovery Program) Investigators. Magnitude and time course of changes induced by continuous-flow left ventricular assist device unloading in chronic heart failure: insights into cardiac recovery. J Am Coll Cardiol. 2013 May 14;61(19):1985-94. doi: 10.1016/j.jacc.2013.01.072. Epub 2013 Mar 14.
PMID: 23500219BACKGROUND
Drakos SG, Kfoury AG, Selzman CH, Verma DR, Nanas JN, Li DY, Stehlik J. Left ventricular assist device unloading effects on myocardial structure and function: current status of the field and call for action. Curr Opin Cardiol. 2011 May;26(3):245-55. doi: 10.1097/HCO.0b013e328345af13.
PMID: 21451407BACKGROUND
Guglin M, Miller L. Myocardial recovery with left ventricular assist devices. Curr Treat Options Cardiovasc Med. 2012 Aug;14(4):370-83. doi: 10.1007/s11936-012-0190-9.
PMID: 22760582BACKGROUND
Healy AH, Bowen M, McKellar SH, Koliopoulou A, Drakos SG, Selzman CH. Interleukin-1 Receptor Antagonism as Adjunct Therapy for Heart Failure Patients with Left Ventricular Assist Devices. ASAIO J. 2021 Aug 1;67(8):e145-e147. doi: 10.1097/MAT.0000000000001347.
PMID: 33470637DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title: Associate Director of Clinical Trials
Organization: University of Utah

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: M.D.

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 11, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 17, 2020

Results First Posted

February 17, 2020

Record last verified: 2020-02

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Anakinra Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Study Design

Study Record Dates

Locations