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Cardiac FailureOPTIMALNCT06939751

OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

An observational study of Cardiac Failure and Graft Rejection, run by Northwestern University at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to develop and refine a microRNA (miR) biomarker panel that can be used to phenotype net immune state after heart transplantation using circulating miRs (associated with drug doses and levels). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Cardiac Failure, Graft Rejection
How many people
250 participants
Where
6 sitesUnited States
Study dates
28 Oct 2025to 1 Jan 2032
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients ≥ 18 years of age from geographically and socioeconomically diverse regions of the U.S who have undergone orthotopic heart transplant (OHT) Patients will be screened for eligibility and enrolled within ~ 1 month after heart transplant

Who may be able to join

  • Age ≥ 18 years at enrollment
  • Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks
  • Planned follow-up at the transplant center for a minimum of one-year.
  • Patient able and willing to comply with the study visit schedule, study procedures, and study requirements.

Who cannot join

  • Recipient of a multi-organ transplant
  • History of prior solid organ transplant before the index heart transplant
  • Ongoing mechanical circulatory support or hemodynamic instability (e.g., inotrope or vasopressor therapy)
  • Ongoing need for renal replacement therapy and/or dialysis
  • Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression
  • Active rejection being treated with intravenous medications or plasmapheresis

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Palak Shah, MD contact

312-694-7805

optimal@northwestern.edu

6 sites in 1 country

United States6 sites, 6 recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Abena Adwetewa-Badu, 617-636-9458, Abena.Adwetewa-Badu@tuftsmedicine.org

    Jeong Hwan Kim, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Melissa Amitrano, amitrano@musc.edu

    Ryan Tedford, MD

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Jasha Harvey, jasha.harvey@BSWHealth.org

    Shelley Hall, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Lucilla Garcia, lucilla.garcia@csmns.org

    Jon Kobashigawa, MD

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, 37232

    Lisa Slinger, Lisa.slinger@vumc.org

    Kelly Schlendorf, MD

    Recruiting

  • Stanford University

    Palo Alto, California, 94304

    James Pak, jamespak@stanford.edu

    Kiran Khush, MD

    Recruiting

Other trials in United States

About this study

This study aims to develop and refine a microRNA (miR) biomarker panel that can be used to phenotype net immune state after heart transplantation using circulating miRs (associated with drug doses and levels). These miRs will be used to characterize the overall immune state in adult heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.

Read the detailed description

The study objectives will be accomplished in a prospective, multicenter observational, longitudinal cohort study that includes ~250 Heart Transplant patients from the United States. Patients will be screened for eligibility and enrolled ~1 month (± 2 weeks) after transplant. Study participation will last 36 months.

All patients will follow the center's standard of care surveillance schedule after transplant. Blood samples will be collected for miR evaluation at:

  1. specified time intervals after transplant and
  2. when a clinical event of interest occurs, including treated rejection, or infection.

Research samples will be collected and used to evaluate miR expression as well as other biomarkers related to heart transplantation and immunosuppression medications. Additional data collection will include demographics, medical history, medications, human leukocyte (HLA)/donor specific antibody (DSA) evaluations, endomyocardial biopsy (EMB) echocardiography, donor-derived cell-free DNA (dd-cfDNA), and other post-transplant events and testing.

This work will form the basis for a non-invasive, genomic blood test that can be used to monitor patients after heart transplant to mitigate complications of over-immunosuppression, such as infection, without increasing the risks of under-immunosuppression, such as rejection.

Medical subject headings
Heart Failure

What is being measured

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

  1. Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients

    A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of infection in heart transplant recipients. Infections are defined as any bacterial, viral, fungal, or opportunistic infection leading to: 1) hospitalization, 2) prescription of antimicrobial therapy, or 3) reduction in immunosuppression

    Measured: up to 3 years post - transplant

  2. Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients

    A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of rejection in heart transplant recipients. Rejection is defined as treated rejection based on 1) endomyocardial biopsy (EMB) pathology, 2) unexplained graft dysfunction, or 3) molecular testing; leading to treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and/or intravenous immunoglobulin (IVIg).

    EMB Pathology: Acute Cellular Rejection (ACR) Grade ≥ 2R and/or Antibody-mediated Rejection (AMR) Grade ≥ pAMR1, per International Society for Heart and Lung Transplantation (ISHLT) grading systems.

    Graft Dysfunction: Left Ventricular Ejection Fraction (LVEF) decline ≥ 10% from baseline and < 50% absolute LVEF by echocardiography.

    Molecular Testing: Presence of 2 of the following 3 criteria-presence of HLA-DSA, elevated donor-derived cell-free DNA (dd-cfDNA), or gene expression results from blood or EMB testing.

    Measured: up to 3 years post - transplant

Timeline

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

  1. First posted23 Apr 2025
  2. Study start28 Oct 2025
  3. Primary completion1 Jan 2031 (estimated)
  4. Study completion1 Jan 2032 (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
250 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06939751
Sponsor's protocol ID
Northwestern-2024-372
Other IDs
1R01HL173248-01A1
Acronym
OPTIMAL
Status last verified
Aug 2026
First submitted
15 Apr 2025
Last updated
11 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shah P, Bristow MR, Port JD. MicroRNAs in Heart Failure, Cardiac Transplantation, and Myocardial Recovery: Biomarkers with Therapeutic Potential. Curr Heart Fail Rep. 2017 Dec;14(6):454-464. doi: 10.1007/s11897-017-0362-8.

    PubMed 28940102

  • Shah P, Agbor-Enoh S, Bagchi P, deFilippi CR, Mercado A, Diao G, Morales DJ, Shah KB, Najjar SS, Feller E, Hsu S, Rodrigo ME, Lewsey SC, Jang MK, Marboe C, Berry GJ, Khush KK, Valantine HA; GRAfT Investigators. Circulating microRNAs in cellular and antibody-mediated heart transplant rejection. J Heart Lung Transplant. 2022 Oct;41(10):1401-1413. doi: 10.1016/j.healun.2022.06.019. Epub 2022 Jun 28.

    PubMed 35872109

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Failure and Graft Rejection, run by Northwestern University at 6 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 6 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Palak Shah, MD (312-694-7805, optimal@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients (time frame: up to 3 years post - transplant). The study lists 2 primary outcomes in all. 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 NCT06939751, which also lists 2 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 11 Aug 2026.

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