Cardiac Allograft VasculopathyDEPICTNCT05756088
Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury by Donor Derived Cell Free DNA
An observational study of Cardiac Allograft Vasculopathy and Endothelial Dysfunction, run by Yale University at 1 site in United States.
Trial summary
The goal of this research study is to understand if a blood test in people who have had heart transplants can detect and predict the following: Blockages in the small blood vessels of the heart. Whether small blockages can turn into more severe blockages in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Allograft Vasculopathy, Endothelial Dysfunction, Microvascular Coronary Artery Disease
- What is being tested?
- Blood draw to measure the levels of dd-cf DNA
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Jun 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: An anticipated total of 88 adults who are undergoing routine stress PET scans as part of post-transplant surveillance will be included. Patients who are at least 3 years from heart transplantation and who meet all eligibility criteria will be enrolled.
Who may be able to join
None listed.
Who cannot join
- Evidence of moderate to large area of ischemia on the PET.
- Multiorgan transplantation.
- Life expectancy <1 year due to non-cardiac conditions.
- Less than 3 years from transplantation.
- Patient appears unlikely or unable to participate in the required study procedures, as assessed by the study PI, study coordinator, or designee (ex: clinically-significant psychiatric, addictive, or neurological disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The DEPICT Prospective Study: Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury as Assessed by Donor Derived Cell Free DNA Post Transplantation
The goal of this research study is to understand if a blood test in people who have had heart transplants can detect and predict the following:
- Blockages in the small blood vessels of the heart.
- Whether small blockages can turn into more severe blockages in the future.
Participants will undergo blood draws once every 3 months in the first year of the study (4 blood draws total, taking 15 minutes each) and their medical records will be reviewed for 3 years after the date they are enrolled in the study.
Read the detailed description
A prospective, single center, assessment of donor derived cell free DNA in subjects who are post-heart transplant to assess correlation with microvascular flow as assessed by myocardial flow reserve (MFR) on positron emission tomography (PET).
Study design: This prospective, single center registry will enroll up to 88 subjects at Yale New Haven Health System (YNHHS). Patients who get PET scans for routine post-transplant surveillance will be included in the study. Up to an anticipated 44 subjects with low MFR and up to an anticipated 44 subjects with normal MFR will have dd-cf DNA drawn every 3 months for a year.
Patient population: A total of 88 adults referred to have an annual PET stress test as part of routine post-transplant surveillance for cardiac allograft vasculopathy and who are at least 3 years from heart transplantation and meet all eligibility criteria will be enrolled.
Diagnostic assessment: All subjects will have quarterly blood draws during the first year of enrollment to assess the levels of dd- cf DNA. All subjects will also undergo standard of care annual PET scans.
Subject follow up: All subjects will have routine follow-up as clinically necessary based on standard of care. Screening and follow-up data collection will occur through the electronic medical record.
Follow up duration: 3 years after enrollment.
Primary endpoint: Elevated dd-cf DNA levels in subjects with low MFR compared to normal MFR at up to one year follow-up post-enrollment.
Secondary Endpoints: The following secondary endpoints will be reported at 3 years post-enrollment based on the routine post-transplant standard of care:
- Combined clinical events of rejection, reduction in ejection fraction, need for revascularization, myocardial infarction, heart failure admissions and death or need for retransplantation.
- All-cause, cardiovascular, and non-cardiovascular mortality
- Myocardial infarction (Fourth Universal Definition)
- Revascularization (PCI or CABG)
- Hospitalization for heart failure
- Rejection
- Decrease in ejection fraction from baseline echo to 3 years follow up.
- Retransplantation
Procedure summary: Patients will undergo routine post-transplant surveillance and management per the discretion of the treating physician and per YNHHS post-heart transplant protocols. Quarterly study blood draws will be conducted in the first year of the study and will include dd-cf DNA measurements. These results will not be available to study team or the patients. All study participants will be blinded to these results.
- Conditions
- Cardiac Allograft Vasculopathy, Endothelial Dysfunction, Microvascular Coronary Artery Disease
- Being tested
- Blood draw to measure the levels of dd-cf DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw to measure the levels of dd-cf DNADiagnostic test
Blood draw to measure the levels of dd-cf DNA.
| Study group | Role | What they receive |
|---|---|---|
| Low MFR (less than or equal to 1.5) | Subjects who are found to have a low MFR of less than or equal to 1.5. Receives: Diagnostic Test: Blood draw to measure the levels of dd-cf DNA | |
| Normal MFR (greater than 1.5) | Subjects who are found to have normal MFR of greater than 1.5. Receives: Diagnostic Test: Blood draw to measure the levels of dd-cf DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
dd-cf DNA and myocardial flow reserve (MFR) on positron emission tomography (PET) scan.
Changes in dd-cf DNA levels in subjects with low MFR compared to normal MFR.
Measured: Baseline up to 1 year
Secondary outcomes (7)
Impact of low MFR on rejection
Changes in rates of rejection in participants with low MFR compared with normal MFR.
Measured: 3 years
Impact of low MFR on left ventricular ejection fraction
Changes in left ventricular ejection fraction in participants with low MFR compared with normal MFR.
Measured: Baseline up to 3 years
Impact of low MFR on need for revascularization
Changes in rates of need for revascularization in participants with low MFR compared with normal MFR.
Measured: 3 years
Impact of low MFR on myocardial infarction (MI)
Changes in rates of MI in participants with low MFR compared with normal MFR.
Measured: 3 years
Impact of low MFR on admissions for heart failure
Changes in number of admissions for heart failure in participants with low MFR compared with normal MFR.
Measured: 3 years
Impact of low MFR on retransplantation
Changes in rates of retransplantation in participants with low MFR compared with normal MFR.
Measured: 3 years
Impact of low MFR on death
Changes in rate of death in participants with low MFR compared with normal MFR.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study startDec 2025 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Why it stopped: Protocol was not approved by the sponsor; therefore PI not moving forward with this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Allograft VasculopathyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale Cardiovascular Research Group, Natera, Inc.
- Responsible party
- Sponsor
- Investigators
- Lavanya Bellumkonda, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756088
- Sponsor's protocol ID
- 2000034497
- Other IDs
- YSI-004
- Acronym
- DEPICT
- Status last verified
- Nov 2025
- First submitted
- 22 Feb 2023
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DEPICT Prospective Study: Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury as Assessed by Donor Derived Cell Free DNA Post Transplantation
- ClinicalTrials.gov ID
- NCT05756088
- Acronym / sponsor ID
- DEPICT / 2000034497
- Conditions
- Cardiac Allograft Vasculopathy, Endothelial Dysfunction, Microvascular Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Protocol was not approved by the sponsor; therefore PI not moving forward with this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Yale Cardiovascular Research Group, Natera, Inc.
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to understand if a blood test in people who have had heart transplants can detect and predict the following:
- Blockages in the small blood vessels of the heart.
- Whether small blockages can turn into more severe blockages in the future.
Participants will undergo blood draws once every 3 months in the first year of the study (4 blood draws total, taking 15 minutes each) and their medical records will be reviewed for 3 years after the date they are enrolled in the study.
Detailed description
A prospective, single center, assessment of donor derived cell free DNA in subjects who are post-heart transplant to assess correlation with microvascular flow as assessed by myocardial flow reserve (MFR) on positron emission tomography (PET).
Study design: This prospective, single center registry will enroll up to 88 subjects at Yale New Haven Health System (YNHHS). Patients who get PET scans for routine post-transplant surveillance will be included in the study. Up to an anticipated 44 subjects with low MFR and up to an anticipated 44 subjects with normal MFR will have dd-cf DNA drawn every 3 months for a year.
Patient population: A total of 88 adults referred to have an annual PET stress test as part of routine post-transplant surveillance for cardiac allograft vasculopathy and who are at least 3 years from heart transplantation and meet all eligibility criteria will be enrolled.
Diagnostic assessment: All subjects will have quarterly blood draws during the first year of enrollment to assess the levels of dd- cf DNA. All subjects will also undergo standard of care annual PET scans.
Subject follow up: All subjects will have routine follow-up as clinically necessary based on standard of care. Screening and follow-up data collection will occur through the electronic medical record.
Follow up duration: 3 years after enrollment.
Primary endpoint: Elevated dd-cf DNA levels in subjects with low MFR compared to normal MFR at up to one year follow-up post-enrollment.
Secondary Endpoints: The following secondary endpoints will be reported at 3 years post-enrollment based on the routine post-transplant standard of care:
- Combined clinical events of rejection, reduction in ejection fraction, need for revascularization, myocardial infarction, heart failure admissions and death or need for retransplantation.
- All-cause, cardiovascular, and non-cardiovascular mortality
- Myocardial infarction (Fourth Universal Definition)
- Revascularization (PCI or CABG)
- Hospitalization for heart failure
- Rejection
- Decrease in ejection fraction from baseline echo to 3 years follow up.
- Retransplantation
Procedure summary: Patients will undergo routine post-transplant surveillance and management per the discretion of the treating physician and per YNHHS post-heart transplant protocols. Quarterly study blood draws will be conducted in the first year of the study and will include dd-cf DNA measurements. These results will not be available to study team or the patients. All study participants will be blinded to these results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low MFR (less than or equal to 1.5) | – | Diagnostic Test: Blood draw to measure the levels of dd-cf DNASubjects who are found to have a low MFR of less than or equal to 1.5. |
| Normal MFR (greater than 1.5) | – | Diagnostic Test: Blood draw to measure the levels of dd-cf DNASubjects who are found to have normal MFR of greater than 1.5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An anticipated total of 88 adults who are undergoing routine stress PET scans as part of post-transplant surveillance will be included. Patients who are at least 3 years from heart transplantation and who meet all eligibility criteria will be enrolled.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Evidence of moderate to large area of ischemia on the PET.
- Multiorgan transplantation.
- Life expectancy <1 year due to non-cardiac conditions.
- Less than 3 years from transplantation.
- Patient appears unlikely or unable to participate in the required study procedures, as assessed by the study PI, study coordinator, or designee (ex: clinically-significant psychiatric, addictive, or neurological disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw to measure the levels of dd-cf DNABlood draw to measure the levels of dd-cf DNA. | Diagnostic test | Low MFR (less than or equal to 1.5), Normal MFR (greater than 1.5) |
Primary outcome
dd-cf DNA and myocardial flow reserve (MFR) on positron emission tomography (PET) scan.
Time frame: Baseline up to 1 year
Changes in dd-cf DNA levels in subjects with low MFR compared to normal MFR.
7 secondary outcomes
Impact of low MFR on rejection
Time frame: 3 years
Impact of low MFR on left ventricular ejection fraction
Time frame: Baseline up to 3 years
Impact of low MFR on need for revascularization
Time frame: 3 years
Impact of low MFR on myocardial infarction (MI)
Time frame: 3 years
Impact of low MFR on admissions for heart failure
Time frame: 3 years
Impact of low MFR on retransplantation
Time frame: 3 years
Impact of low MFR on death
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lavanya Bellumkonda, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Allograft Vasculopathy and Endothelial Dysfunction, run by Yale University at 1 site 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 0 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dd-cf DNA and myocardial flow reserve (MFR) on positron emission tomography (PET) scan. (time frame: Baseline up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2025.