The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Individuals

• Conditions: HIV/AIDS; Cardiovascular Diseases

• Registration Number: NCT04463810
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The present study aims to evaluate the cardiovascular changes in long-term virologically controlled HIV patients. All the participants have been treated and have been undetected for at least five years. Vascular ultrasound and echo will be carried out at 0, 24, 48 and 96 weeks of follow-up.

Detailed Description

Previous studies have indicated that chronic HIV infection has resulted the diastolic cardiac dysfunction. In this study, 500 long-term virologically controlled HIV-infected individuals will be followed for two years, and evaluated at 0, 24, 48 and 96 weeks of follow-up. At each visiting point, ultrasound evaluation of carotid and vertebral arteries and the heart function will be carried out and compared.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-07-15
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-03
• Last Update Submitted: 2020-07-03
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09
• Primary Completion: 2020-12
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Provision of signed and dated informed consent form
• Willingness and availability to engage in study activities for the duration of the study
• Age between 18-65
• Documented HIV-1 infection (confirmed by Western blot)
• regular ART treated for over 240 weeks
• HIV-RNA < 200 cp/ml

Exclusion Criteria

• Pregnancy or breastfeeding or anticipated pregnancy in two years
• History of AIDS-defining illness
• Virological failure during the ART ( Definition of virolgocial failure: plasma HIV-RNA > 200 cp/ml upon continuous HARRT)
• Hemoglobin < 9g/dl；or peripheral white blood cell counts < 2000/μl；or neutrophil counts < 1000 /μl；or platelet count < 75,000/μl；
• Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
• Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
• Patients with a history of injection drug usage
• Patients with a history of mental disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 48 weeks	48 weeks	The ankle-brachial index (ABI) and pulse wave velocity (PWV) including right and left brachial-ankle are aceessed through ultrasound. The measured value will be documented and evaluated for abnormality.
Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 96 weeks	96 weeks	The ankle-brachial index (ABI) and pulse wave velocity (PWV) including right and left brachial-ankle are aceessed through ultrasound. The measured value will be documented and evaluated for abnormality.
Number of Participants with abnormal echocardiogram results at 48 weeks	48 weeks	Echocardiogram indicators include left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular fractional shortening (LVFS), ejection fraction (EF), E/A ratio, E-wave deceleration time (EDT), isovolumetric relaxation time (IVRT), tricuspid regurgitation velocity (TRV), Pulmonary artery systolic pressure, Interventricular septal (IVS ) thickness, left ventricular posterior wall thickness, the present of valve abnormalities/ myocardial ischemia/ pericardial effusion. The measured value will be documented and evaluated for abnormality.
Number of Participants with abnormal echocardiogram results at 96 weeks	96 weeks	Echocardiogram indicators include left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular fractional shortening (LVFS), ejection fraction (EF), E/A ratio, E-wave deceleration time (EDT), isovolumetric relaxation time (IVRT), tricuspid regurgitation velocity (TRV), Pulmonary artery systolic pressure, Interventricular septal (IVS ) thickness, left ventricular posterior wall thickness, the present of valve abnormalities/ myocardial ischemia/ pericardial effusion. The measured value will be documented and evaluated for abnormality.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline T cellular activation markers	0,24,48 and 96weeks	Changes from baseline T cellular activation markers (CD8CD38+ T percentage and CD8DR+ T percentage).
Changes from baseline serum inflammatory markers	0,24,48 and 96weeks	Changes from baseline serum inflammatory markers (sCD14, D-dimer, IL-6, IP-10)

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China