Clinical trial NCT04330287: HIV-HEART Aging Study
Official title: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 15 Year Follow up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Coronary Disease
Myocardial Infarction
HIV Encephalopathy
Aging
Heart Failure
Weight Gain
Keywords: HIV
AIDS
Antiretroviral therapy
Aging
Heart Failure
coronary heart desease
myocardial infarction
HIV-associated neurocognitive disorders
weight gain
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: population affected by HIV

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

Eligibility criteria: 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

Primary outcomes:
measure: Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection
timeFrame: Baseline up to 15 year follow up
measure: Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection
timeFrame: Baseline up to 15 year follow up
Secondary outcomes:
measure: Impact on cardiovascular risk on amount of atherosclerosis
timeFrame: Baseline up to 15 year follow up
measure: Impact on life quality
timeFrame: Baseline up to 15 year follow up
measure: Impact on life quality
timeFrame: Baseline up to 15 year follow up
measure: Impact on life quality
timeFrame: Baseline up to 15 year follow up
measure: Impact on cardiovascular risk, amount of atherosclerosis and life quality
timeFrame: Baseline up to 15 year follow up
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Institut für Medizinische Informatik, Biometrie und Epidemiologie
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Klinik für Dermatologie
state: Nordrheinwestfalen
city: Duisburg
country: Germany
facility: HIV physician pratice
state: NRW
city: Bochum
country: Germany
facility: University Hospital of Bochum, Department of Dermatology
city: Dortmund
country: Germany
facility: HIV Outpatient Department
Study officials:
References:
citation: Kehrmann J, Menzel J, Saeedghalati M, Obeid R, Schulze C, Holzendorf V, Farahpour F, Reinsch N, Klein-Hitpass L, Streeck H, Hoffmann D, Buer J, Esser S; HIV-HEART Study Group. Gut Microbiota in Human Immunodeficiency Virus-Infected Individuals Linked to Coronary Heart Disease. J Infect Dis. 2019 Jan 9;219(3):497-508. doi: 10.1093/infdis/jiy524.
citation: Reinsch N, Streeck H, Holzendorf V, Schulze C, Neumann T, Brockmeyer NH, Kehrmann J, Schadendorf D, Esser S; HIV HEART Study Group. B-type natriuretic peptides for the prediction of cardiovascular events and mortality in patients living with HIV: Results from the HIV-HEART study. Int J Cardiol. 2019 Apr 15;281:127-132. doi: 10.1016/j.ijcard.2019.01.066. Epub 2019 Jan 23.
citation: Schulz CA, Mavarani L, Reinsch N, Albayrak-Rena S, Potthoff A, Brockmeyer N, Hower M, Erbel R, Jockel KH, Schmidt B, Esser S; HIV HEART Aging Study Group and Heinz Nixdorf Recall Investigative Group. Prediction of future cardiovascular events by Framingham, SCORE and asCVD risk scores is less accurate in HIV-positive individuals from the HIV-HEART Study compared with the general population. HIV Med. 2021 Sep;22(8):732-741. doi: 10.1111/hiv.13124. Epub 2021 May 24.
citation: Mavarani L, Albayrak-Rena S, Potthoff A, Hower M, Dolff S, Sammet S, Maischack F, Schadendorf D, Schmidt B, Esser S; HIV HEART AGING Study. Changes in body mass index, weight, and waist-to-hip ratio over five years in HIV-positive individuals in the HIV Heart Aging Study compared to the general population. Infection. 2023 Aug;51(4):1081-1091. doi: 10.1007/s15010-023-02009-8. Epub 2023 Mar 17.