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OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults who recently had a heart transplant. It will study microRNAs, tiny molecules in the blood that help control how genes work, to learn how active the immune system is. The goal is to predict who may get an infection or have rejection, when the immune system attacks the new heart.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older when you join.
  • You had a heart transplant about 1 month ago, within a range of 2 to 6 weeks.
  • You plan to get follow-up care at the transplant center for at least 1 year.
  • You are able and willing to follow the study visit schedule, procedures, and requirements.

Who can't join

  • You received more than one organ in the transplant.
  • You had another solid organ transplant before this heart transplant.
  • You still need a machine to help your heart pump blood, or your blood flow or blood pressure is not stable, such as needing drugs to support them.
  • You still need dialysis or another treatment to do the work of your kidneys.
  • You have an active infection that needs a hospital stay, medicine to fight the infection, or lower doses of drugs that weaken your immune system.
  • You have active rejection being treated with medicine through a vein or a treatment that removes and replaces the liquid part of your blood.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Study sites (6)

CA

MA

SC

TN

TX