HIV-HEART Aging Study (15 Year Follow up)

Sponsor
University Hospital, Essen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04330287
Collaborator
(none)
2,000
5
31.7
400
12.6

Study Details

Study Description

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) 1806 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

  • Exercise electrocardiogram

  • Exercise Montreal Cognitive Assessment test

  • Exercise the Grooved Pegboard test

  • Blood and stool sample collection

  • Questionnaire to quality of life and health economics

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
May 11, 2020
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. 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%.

  2. 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

  1. 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

  2. Impact on life quality [Baseline up to 15 year follow up]

    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

  3. Impact on life quality [Baseline up to 15 year follow up]

    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

  4. 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

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut für Medizinische Informatik, Biometrie und Epidemiologie Essen Nordrhein-Westfalen Germany 45147
2 Universitätsklinikum Essen, Klinik für Dermatologie Essen Nordrheinwestfalen Germany 45147
3 HIV physician pratice Duisburg NRW Germany 47259
4 University Hospital of Bochum, Department of Dermatology Bochum Germany 44791
5 HIV Outpatient Department Dortmund Germany 44137

Sponsors and Collaborators

  • University Hospital, Essen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stefan Esser M.D., PD M.D. Head of HPSTD Ambulance, University Hospital, Essen, Principal Investigator, University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT04330287
Other Study ID Numbers:
  • 14-5874-BO
First Posted:
Apr 1, 2020
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stefan Esser M.D., PD M.D. Head of HPSTD Ambulance, University Hospital, Essen, Principal Investigator, University Hospital, Essen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2021