RecruitingNCT04330287

HIV-HEART Aging Study

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


Sponsor

University Hospital, Essen

Enrollment

2,000 participants

Start Date

May 11, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria3

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

Locations(5)

Universitätsklinikum Essen, Klinik für Dermatologie

Essen, Nordrheinwestfalen, Germany

HIV physician pratice

Duisburg, North Rhine-Westphalia, Germany

Institut für Medizinische Informatik, Biometrie und Epidemiologie

Essen, North Rhine-Westphalia, Germany

University Hospital of Bochum, Department of Dermatology

Bochum, Germany

HIV Outpatient Department

Dortmund, Germany

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NCT04330287


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