Immune Correlates of Cardiac Structure and Function

Cardiac Fibrosis Clinical Trial

Official title:

Immune Correlates of Cardiac Structure and Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05328713
• Other study ID #: Pro00109701
• Secondary ID: 1R56HL152803-01
• Status: Completed
• Start date: May 9, 2022
• Est. completion date: September 21, 2022

Study information

• Verified date: October 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 21, 2022
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Individuals 20-45 years of age

2. Willingness and ability to provide signed and dated written informed consent, prior to any study-related procedures

3. Diagnosed with HIV <10 years of age or physician confirmation of perinatal HIV infection

4. On antiretroviral treatment (ART) for at least the last greater than or equal to 6 months

5. Willingness to undergo Cardiovascular magnetic resonance imaging (CMR)

6. Willingness to undergo echocardiogram (ECHO) (may be included if ECHO has been done at Duke in the previous 24 months).

7. Willingness to have research blood draw

Exclusion Criteria:

1. Contraindication to CMR (metal fragments in eyes or face, implanted electronic devices such as pacemakers, defibrillators, cochlear implants, or nerve stimulators, aneurysm clips)

2. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2

3. History of anaphylactic reaction to gadolinium contrast

4. Inability to complete an MRI scan in the past due to anxiety

5. Recent acute medical illness resulting in recent hospitalization (in past 90 days)

6. 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

7. Current Symptoms of Shortness of breath, severe chest pain, palpations, difficulty breathing on exertion, swelling of legs

8. Known to be pregnant or current breastfeeding

9. Known to be on hemodialysis

10. Inability to breath hold for 5-10 seconds

11. Known to have an ejection fraction <45% in the past 24 months

12. Active cancer or cancer chemotherapy or radiation treatment in the prior year.

13. Comorbid inflammatory disease, specifically treated for rheumatoid arthritis (RA) or lupus (SLE)

14. Chronic use of steroids or anti-inflammatory therapy

Related Conditions & MeSH terms

• Cardiac Fibrosis
• Cardiac Inflammation
• Inflammation
• Perinatal HIV Infection

Intervention

Diagnostic Test:
• Cardiac MRI
This study will use Cardiac MRI to identify subclinical cardiac dysfunction.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging	Compare myocardial fibrosis for HIV+ and control subjects (unit = percentage)	Baseline Visit
Secondary	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)	Baseline Visit
Secondary	Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imaging	Compare native T2 mapping values for HIV+ and control subjects (unit = ms)	Baseline Visit
Secondary	Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imaging	Compare native T1 mapping values for HIV+ and control subjects (unit = ms)	Baseline Visit
Secondary	Extra-cellular volume (ECV) cardiac magnetic resonance imaging	Compare ECV for HIV+ and control subjects (unit=percentage)	Baseline Visit