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RecruitingPhase 4

Allograft Dysfunction in Heart Transplant

Defining Mechanisms for Cardiac Allograft Dysfunction to Improve Allograft Longevity and Survival in Heart-Transplant Patients

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 and older
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: MRI scans, 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
  • "The investigators will evaluate for early evidence of cardiac allograft dysfunction by cardiac MRI and single cell sequencing to determine underlying molecular and macroscopic causes."
  • "Brief protocol: Cardiac MRI is performed."
  • "Peripheral blood and endomyocardial biopsies will also be collected, timing as per usual clinical care as well as for-cause, for single cell RNAseq analyses."
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 looks for early signs that a transplanted heart is not working well. It uses heart MRI scans and tests of individual cells to learn why this happens. It is for adults who had a heart transplant at least 3 months ago.

The investigators will evaluate for early evidence of cardiac allograft dysfunction by cardiac MRI and single cell sequencing to determine underlying molecular and macroscopic causes.

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 18 or older.
  • You had a heart transplant at least 3 months ago.

Who can't join

  • A tissue test showed sudden rejection of your transplanted heart in the past 3 months.
  • You have signs or symptoms of low blood flow to the heart, or had a sudden heart problem from low blood flow in the past 3 months.
  • You have uncontrolled asthma or COPD, lung diseases that make breathing hard, or a history of seizures with whole-body stiffening and shaking.
  • You have second- or third-degree heart block (blocked electrical signals), or a problem with the heart's natural pacemaker.
  • You cannot safely have an MRI, including because of an implanted electronic heart device, or you have a severe fear of tight spaces.
  • Your kidney filtering rate, called eGFR, is below 30.
  • You had a bad reaction to regadenoson or gadolinium MRI dye. Past reactions to adenosine or dipyridamole will be reviewed case by case.
  • Your top blood pressure number is above 180 or below 85, your bottom number is above 120 or below 40, or your resting heart rate is above 120 or below 45 beats per minute.

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

Official eligibility criteria

Inclusion Criteria: * Age greater than or equal to 18 years old. * At least three months status post heart transplantation. Exclusion Criteria: * Biopsy proven acute rejection episode in the past 3 months. * Patients with symptoms or signs of acute myocardial ischemia or recent acute coronary syndrome in the past 3 months. * Uncontrolled obstructive ventilatory disease including asthma and COPD. * History of generalized tonic-clonic seizures. * Second or third degree AV nodal block. * Sinus node dysfunction. * Contraindications to MRI including cardiovascular implantable electronic devices. * Renal dysfunction with an estimated GFR less than 30 mL/min/1.73m2. * Prior adverse reaction to either regadenoson or gadolinium contrast. Prior adverse reaction to adenosine or dipyridamole will be assessed on a case-by-case basis. * Systolic blood pressure greater than 180 or less than 85 mmHg. * Diastolic blood pressure greater than 120 or less than 40 mmHg. * Resting heart rate greater than 120 or less than 45 beats per minute. - Severe claustrophobia.

Study sites (1)

CA