Clinical trial NCT05258942: MyLeukoMAP™ Genomic Survival Prediction Assay Pivotal Clinical Study
Official title: MyLeukoMAP™ Genomic Survival Prediction Assay for Heart Failure Pivotal Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: LeukoLifeDx Inc
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Participants: All study participants will be referred to the AdHF Program at one of the study investigational sites, evaluated for the various therapeutic options outlined below, and scheduled for HF-surgical / interventional therapy. All patients will be optimized regarding HF therapy, consented, and prescribed one of 10 HF procedures according to established guidelines, based on the recommendations of the AdHF team of the participating study centers.

Brief summary: The MyLeukoMAP™ Pivotal Clinical Study will assess the accuracy of MyLeukoMAP™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for Heart Failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools.

Detailed description: The MyLeukoMAP™ Pivotal Clinical Study will assess the accuracy of MyLeukoMAP™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for Heart Failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools.

Patients scheduled for one of 10 different Heart Failure surgical / interventional therapies will be identified and consented. Four clinical parameters will be collected for each patient: age, white blood cell count, blood pressure, and respiratory rate. Blood samples will be collected concurrent with a routine preoperative blood draw, and peripheral blood mononuclear cells (PBMC's) will be isolated. The PBMC samples will be shipped to ResearchDx, Irvine, CA, for testing using the MyLeukoMAP™ genomic survival prediction assay. Patient 1-year postoperative survival/non-survival data will be reported for each patient.

The samples will be tested 1-year after the intervention of the last enrolled patient, and the data will be compared to actual patient 1-year survival to determine the survival prediction accuracy of the assay. The investigators anticipate that the assay will better identify those 20% of patients who currently do not achieve 1-year postoperative survival, and who would have better odds of survival by remaining on medical therapy, but who cannot be identified with current tools.

Eligibility criteria: Inclusion Criteria:

Criteria #1: AdHF with NYHA III/IV

Criteria #2: Left Ventricular Ejection Fraction (LVEF) \<35% or \>2+valvular disease severity \& \>low risk Society of Thoracic Surgeons (STS)-score

Criteria #3: Evaluation for interventions including CABG/PCI (Stratum #1, Ischemia), Surgical Valve Replacement/TAVR/Mitra-Clip (Stratum #2, Overload), VT-Ablation/Stellate Gangliectomy (Stratum #3, Arrhythmia), or MCS/HTx (Stratum #4, Contractility)

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Exclusion Criteria:

Criteria #1: No informed consent Criteria #2: \<18 years old

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Primary outcomes:
measure: Survival / Non-Survival
timeFrame: 1-year (365-455 Days) Post Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
Study officials:
affiliation: University California Los Angeles
name: Megan Kamath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bondar G, Togashi R, Cadeiras M, Schaenman J, Cheng RK, Masukawa L, Hai J, Bao TM, Chu D, Chang E, Bakir M, Kupiec-Weglinski S, Groysberg V, Grogan T, Meltzer J, Kwon M, Rossetti M, Elashoff D, Reed E, Ping PP, Deng MC. Association between preoperative peripheral blood mononuclear cell gene expression profiles, early postoperative organ function recovery potential and long-term survival in advanced heart failure patients undergoing mechanical circulatory support. PLoS One. 2017 Dec 13;12(12):e0189420. doi: 10.1371/journal.pone.0189420. eCollection 2017.
citation: Deng MC. A peripheral blood transcriptome biomarker test to diagnose functional recovery potential in advanced heart failure. Biomark Med. 2018 Jun;12(6):619-635. doi: 10.2217/bmm-2018-0097. Epub 2018 May 8.
citation: Bondar G, Cadeiras M, Wisniewski N, Maque J, Chittoor J, Chang E, Bakir M, Starling C, Shahzad K, Ping P, Reed E, Deng M. Comparison of whole blood and peripheral blood mononuclear cell gene expression for evaluation of the perioperative inflammatory response in patients with advanced heart failure. PLoS One. 2014 Dec 17;9(12):e115097. doi: 10.1371/journal.pone.0115097. eCollection 2014.