HIV-HEART Aging Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Known HIV-infection

Signed informed consent

Disqualifiers

Acute cardiovascular disease

Unstable hemodynamic status in the three weeks before inclusion

Pregnancy

Trial population

population affected by HIV

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection

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%.

Time frame
Baseline up to 15 year follow up
2

Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection

Calculation of Odds Ratio

Time frame
Baseline up to 15 year follow up

Secondary outcomes

1

Impact on cardiovascular risk on amount of atherosclerosis

in relation to age, gender and classic cardiovascular rsik factors inter alia smoking, diabetes, hypercholesterinaemia and arterial hypertension by calculating the relative risk

Time frame
Baseline up to 15 year follow up
2

Impact on life quality

in relation to HIV-specfic cardiovascular rsik factors including inter alia virus load (copies/ml) in combination with CD4-count and duration of HV-Infection by calculating the standard deviation

Time frame
Baseline up to 15 year follow up
3

Impact on life quality

in relation to HIV-specfic cardiovascular rsik factors including inter alia CD4-count (cells/mm3) in combination with virus load and duration of HIV-infection by calculating the standard deviation

Time frame
Baseline up to 15 year follow up
4

Impact on life quality

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

Time frame
Baseline up to 15 year follow up

Other outcomes

Sponsors and contacts

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