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

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Age > 18 years

• Known HIV-infection

• Signed informed consent

Locations
Other Locations
Germany
University Hospital of Bochum, Department of Dermatology
Not yet recruiting
Bochum
HIV Outpatient Department
Not yet recruiting
Dortmund
HIV physician pratice
Not yet recruiting
Duisburg
Institut für Medizinische Informatik, Biometrie und Epidemiologie
Active, not recruiting
Essen
Universitätsklinikum Essen, Klinik für Dermatologie
Recruiting
Essen
Contact Information
Primary
Stefan Esser, PD MD
stefan.esser@uk-essen.de
00492017233878
Backup
Sarah Albayrak-Rena
sarah.albayrak-rena@uk-essen.de
004920172383721
Time Frame
Start Date: May 11, 2020
Estimated Completion Date: December 31, 2025
Participants
Target number of participants: 2000
Sponsors
Leads: University Hospital, Essen

This content was sourced from clinicaltrials.gov

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