HIV-HEART Aging Study

Recruiting

• Conditions: HIV Infections; Myocardial Infarction; Aging; Heart Failure; Coronary Disease; HIV Encephalopathy; Weight Gain

• Registration Number: NCT04330287
• Lead Sponsor: University Hospital, Essen

Brief Summary

The HIV/HEART Aging study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to October 2022 (15 year Follow-up) 1858 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

Detailed Description

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Comprehensive non invasive cardiovascular examination

* Anamnesis

* File recherche,Physical examination

* Documentation of the cardiovascular and antiretroviral medical therapy

* Electrocardiogram

* Transthoracic echocardiography (optional)

* Exercise electrocardiogram (optional)

* Exercise Montreal Cognitive Assessment test (optional)

* Exercise the Grooved Pegboard test (optional)

* Blood and stool sample collection (optional)

* Questionnaire to quality of life and health economics

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-04-01
• Study Start: 2020-05-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Age > 18 years
• Known HIV-infection
• Signed informed consent

Exclusion Criteria

• Acute cardiovascular disease
• Unstable hemodynamic status in the three weeks before inclusion
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection	Baseline up to 15 year follow up	Calculation of the Framingham Risk Score. It was assumed, that in the next 10 years the individual cardiovascular risk varies between maximal 20% and minimal 0%.
Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection	Baseline up to 15 year follow up	Calculation of Odds Ratio

Secondary Outcome Measures

Name	Time	Method
Impact on cardiovascular risk on amount of atherosclerosis	Baseline up to 15 year follow up	in relation to age, gender and classic cardiovascular rsik factors inter alia smoking, diabetes, hypercholesterinaemia and arterial hypertension by calculating the relative risk
Impact on life quality	Baseline up to 15 year follow up	in relation to HIV-specfic cardiovascular rsik factors including inter alia duration of HIV-Infection (in years) in combination with virus load and CD4-count by calculating the standard deviation
Impact on cardiovascular risk, amount of atherosclerosis and life quality	Baseline up to 15 year follow up	in relation to cardiovascular and antiretroviral medication by calculating the 95%-Confidence interval

Trial Locations

Locations (5)

University Hospital of Bochum, Department of Dermatology; 🇩🇪 Bochum, Germany

Institut für Medizinische Informatik, Biometrie und Epidemiologie; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Universitätsklinikum Essen, Klinik für Dermatologie; 🇩🇪 Essen, Nordrheinwestfalen, Germany

HIV physician pratice; 🇩🇪 Duisburg, NRW, Germany

HIV Outpatient Department; 🇩🇪 Dortmund, Germany