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Heart FailureNCT05258942

MyLeukoMAP™ Genomic Survival Prediction Assay Pivotal Clinical Study

An observational study of Heart Failure, run by LeukoLifeDx Inc at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Observational
How many people
300 participants
Where
3 sitesUnited States
Study dates
1 Jul 2022to Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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)
  • -

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Simran Prajapat, PhD contact

617.820.3725

sprajapat@researchdx.com

Gordon Vansant, PhD contact

760.473.4295

gvansant@researchdx.com

United States3 sites, 3 recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Andrew Kao, MD, 816-931-1883, akao@cc-pc.com

    Brenda Akers, BSN, 816.932.1627, bakers@saint-lukes.org

    Recruiting

  • Yale University

    New Haven, Connecticut, 06511

    Lavanya Bellumkonda, MD, 203-785-7191, lavanya.bellumkonda@yale.edu

    Jill Boria, RN, jill.boria@yale.edu

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32803

    Nirav Raval, MD, nirav.raval.md@flhosp.org

    Jennifer Lyden, BSN, 407.303.2988, jennifer.lyden@adventhealth.com

    Recruiting

Other trials in United States

About this study

Official title: MyLeukoMAP™ Genomic Survival Prediction Assay for Heart Failure Pivotal Clinical Study

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.

Read the 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.

Conditions
Heart Failure
Being tested
Observational
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

    Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.

Study groups in NCT05258942
Study groupRoleWhat they receive
Heart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) SurgeryHeart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) Surgery
Receives: Other: Observational
Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI)Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI)
Receives: Other: Observational
Heart Failure Patients Scheduled for Aortic Valve Replacement (AVR) SurgeryHeart Failure Patients Scheduled for Aortic Valve Replacement (AVR) Surgery
Receives: Other: Observational
Heart Failure Patients Scheduled for Mitral Valve Replacement (MVR) SurgeryHeart Failure Patients Scheduled for Mitral Valve Replacement (MVR) Surgery
Receives: Other: Observational
Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR)Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR)
Receives: Other: Observational
Heart Failure Patients Scheduled for Transcatheter Mitra ClipHeart Failure Patients Scheduled for Transcatheter Mitra Clip
Receives: Other: Observational
Heart Failure Patients Scheduled for Ventricular Tachycardia AblationHeart Failure Patients Scheduled for Ventricular Tachycardia Ablation
Receives: Other: Observational
Heart Failure Patients Scheduled for Stellate GangliectomyHeart Failure Patients Scheduled for Stellate Gangliectomy
Receives: Other: Observational
Heart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) SurgeryHeart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) Surgery
Receives: Other: Observational
Heart Failure Patients Scheduled for Heart Transplantation (HTx) SurgeryHeart Failure Patients Scheduled for Heart Transplantation (HTx) Surgery
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival / Non-Survival

    Patient Survival Status

    Measured: 1-year (365-455 Days) Post Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start1 Jul 2022
  3. Primary completionJun 2023 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05258942
Sponsor's protocol ID
LLDx1012021
Status last verified
Jul 2022
First submitted
17 Feb 2022
Last updated
27 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29236770

  • 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.

    PubMed 29737882

  • 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.

    PubMed 25517110

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by LeukoLifeDx Inc at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Simran Prajapat, PhD (617.820.3725, sprajapat@researchdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival / Non-Survival (time frame: 1-year (365-455 Days) Post Intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05258942, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.

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