Perinatal HIV InfectionNCT05328713
Immune Correlates of Cardiac Structure and Function
An observational study of Perinatal HIV Infection and Cardiac Fibrosis, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the occurrence of scarring of the heart (cardiac fibrosis) and inflammation in those with perinatally acquired Human Immunodeficiency Virus (HIV) infection compared to people not infected with HIV. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Perinatal HIV Infection, Cardiac Fibrosis, Cardiac Inflammation
- What is being tested?
- Cardiac MRI
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 21 Sep 2022
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Recruitment will be from Adult or Pediatric Infectious Disease (ID) Clinics at DUHS and other clinic sites where Duke providers deliver care for HIV.
Who may be able to join
- Individuals 20-45 years of age
- Willingness and ability to provide signed and dated written informed consent, prior to any study-related procedures
- Diagnosed with HIV <10 years of age or physician confirmation of perinatal HIV infection
- On antiretroviral treatment (ART) for at least the last greater than or equal to 6 months
- Willingness to undergo Cardiovascular magnetic resonance imaging (CMR)
- Willingness to undergo echocardiogram (ECHO) (may be included if ECHO has been done at Duke in the previous 24 months).
- Willingness to have research blood draw
Who cannot join
- Contraindication to CMR (metal fragments in eyes or face, implanted electronic devices such as pacemakers, defibrillators, cochlear implants, or nerve stimulators, aneurysm clips)
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
- History of anaphylactic reaction to gadolinium contrast
- Inability to complete an MRI scan in the past due to anxiety
- Recent acute medical illness resulting in recent hospitalization (in past 90 days)
- History of: Coronary artery disease (CAD), Myocardial infarction (MI), moderate-severe valvular disease, congenital heart disease, heart failure, non-ischemic CM, Atrial fibrillation/flutter, implantable cardioverter defibrillator (ICD)/pacemaker, myocarditis prior
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- Current Symptoms of Shortness of breath, severe chest pain, palpations, difficulty breathing on exertion, swelling of legs
- Known to be pregnant or current breastfeeding
- Known to be on hemodialysis
- Inability to breath hold for 5-10 seconds
- Known to have an ejection fraction <45% in the past 24 months
- Active cancer or cancer chemotherapy or radiation treatment in the prior year.
- Comorbid inflammatory disease, specifically treated for rheumatoid arthritis (RA) or lupus (SLE)
- Chronic use of steroids or anti-inflammatory therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine the occurrence of scarring of the heart (cardiac fibrosis) and inflammation in those with perinatally acquired Human Immunodeficiency Virus (HIV) infection compared to people not infected with HIV. The information learned from this research may help the investigator to better understand the link between cardiac fibrosis and cardiac dysfunction and inflammation in those with perinatally acquired HIV infection compared to the uninfected.
Participants will have a blood sample, complete a patient questionnaire, and have a Magnetic resonance imaging (MRI) and ultrasound of the heart.
Read more
Researchers will review the medical record and past medical history, for information about your heart function and overall health. Research samples and data from this study will be stored indefinitely and used for other research.
There are risks to participate in this study and those risks include side effects from the contrast agent used for the MRI scan, (such as headache and injection site pain), and risks from blood sampling.
- Being tested
- Cardiac MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
This study will use Cardiac MRI to identify subclinical cardiac dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Prospective group with perinatally acquired HIV infection from Duke University Health System clinics | Not described Receives: Diagnostic Test: Cardiac MRI | |
| Control retrospective group | A retrospective age- and sex-matched HIV-uninfected comparator group from Duke University Health System (DUHS) electronic health record (EHR) and imaging database systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging
Compare myocardial fibrosis for HIV+ and control subjects (unit = percentage)
Measured: Baseline Visit
Secondary outcomes (4)
Cardiac function evaluated using cine cardiac magnetic resonance imaging
Compare Left ventricular ejection fraction (LVEF) for HIV+ and control subjects (unit = percentage) Compare left ventricle (LV) mass for HIV+ and control subjects (unit = grams)
Measured: Baseline Visit
Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imaging
Compare native T2 mapping values for HIV+ and control subjects (unit = ms)
Measured: Baseline Visit
Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imaging
Compare native T1 mapping values for HIV+ and control subjects (unit = ms)
Measured: Baseline Visit
Extra-cellular volume (ECV) cardiac magnetic resonance imaging
Compare ECV for HIV+ and control subjects (unit=percentage)
Measured: Baseline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start9 May 2022
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal HIV InfectionStudies of the same condition, open and under way.
- More trials run by Duke 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
- Case-control
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gerald Bloomfield, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328713
- Sponsor's protocol ID
- Pro00109701
- Other IDs
- 1R56HL152803-01
- Status last verified
- Oct 2022
- First submitted
- 28 Mar 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams JL, Hung F, Jenista E, Barker P, Chakraborty H, Kim R, McCrary AW, Shah SH, Thielman N, Bloomfield GS. Diffuse myocardial fibrosis is uncommon in people with perinatally acquired human immunodeficiency virus infection. AIDS Res Ther. 2024 Mar 4;21(1):13. doi: 10.1186/s12981-024-00598-4.
PubMed 38439093
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Correlates of Cardiac Structure and Function
- ClinicalTrials.gov ID
- NCT05328713
- Acronym / sponsor ID
- Pro00109701
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 14 Apr 2022 (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 purpose of this study is to determine the occurrence of scarring of the heart (cardiac fibrosis) and inflammation in those with perinatally acquired Human Immunodeficiency Virus (HIV) infection compared to people not infected with HIV. The information learned from this research may help the investigator to better understand the link between cardiac fibrosis and cardiac dysfunction and inflammation in those with perinatally acquired HIV infection compared to the uninfected.
Participants will have a blood sample, complete a patient questionnaire, and have a Magnetic resonance imaging (MRI) and ultrasound of the heart.
Researchers will review the medical record and past medical history, for information about your heart function and overall health. Research samples and data from this study will be stored indefinitely and used for other research.
There are risks to participate in this study and those risks include side effects from the contrast agent used for the MRI scan, (such as headache and injection site pain), and risks from blood sampling.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective group with perinatally acquired HIV infection from Duke University Health System clinics | – | Diagnostic Test: Cardiac MRI |
| Control retrospective group | – | –A retrospective age- and sex-matched HIV-uninfected comparator group from Duke University Health System (DUHS) electronic health record (EHR) and imaging database systems |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Recruitment will be from Adult or Pediatric Infectious Disease (ID) Clinics at DUHS and other clinic sites where Duke providers deliver care for HIV.
Key inclusion criteria (7 listed)
- Individuals 20-45 years of age
- Willingness and ability to provide signed and dated written informed consent, prior to any study-related procedures
- Diagnosed with HIV <10 years of age or physician confirmation of perinatal HIV infection
- On antiretroviral treatment (ART) for at least the last greater than or equal to 6 months
- Willingness to undergo Cardiovascular magnetic resonance imaging (CMR)
Key exclusion criteria (14 listed)
- Contraindication to CMR (metal fragments in eyes or face, implanted electronic devices such as pacemakers, defibrillators, cochlear implants, or nerve stimulators, aneurysm clips)
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
- History of anaphylactic reaction to gadolinium contrast
- Inability to complete an MRI scan in the past due to anxiety
- Recent acute medical illness resulting in recent hospitalization (in past 90 days)
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 |
|---|---|---|
| Cardiac MRIThis study will use Cardiac MRI to identify subclinical cardiac dysfunction. | Diagnostic test | Prospective group with perinatally acquired HIV infection from Duke University Health System clinics |
Primary outcome
Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging
Time frame: Baseline Visit
Compare myocardial fibrosis for HIV+ and control subjects (unit = percentage)
4 secondary outcomes
Cardiac function evaluated using cine cardiac magnetic resonance imaging
Time frame: Baseline Visit
Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imaging
Time frame: Baseline Visit
Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imaging
Time frame: Baseline Visit
Extra-cellular volume (ECV) cardiac magnetic resonance imaging
Time frame: Baseline Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 38439093Williams JL, Hung F, Jenista E, Barker P, Chakraborty H, Kim R, McCrary AW, Shah SH, Thielman N, Bloomfield GS. Diffuse myocardial fibrosis is uncommon in people with perinatally acquired human immunodeficiency virus infection. AIDS Res Ther. 2024 Mar 4;21(1):13. doi: 10.1186/s12981-024-00598-4.
- Individual participant dataSharing planned: No
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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.
Gerald Bloomfield, MD principal investigator
Duke 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 Perinatal HIV Infection and Cardiac Fibrosis, run by Duke 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 21 Mar 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging (time frame: Baseline Visit). 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 NCT05328713, which also lists 1 linked publication.
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 21 Mar 2024.