HIV-HEART Aging Study (HIVH)

May 11, 2023 updated by: Stefan Esser M.D., University Hospital, Essen

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

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.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bochum, Germany, 44791
        • Not yet recruiting
        • University Hospital of Bochum, Department of Dermatology
        • Contact:
      • Dortmund, Germany, 44137
    • NRW
      • Duisburg, NRW, Germany, 47259
        • Not yet recruiting
        • HIV physician pratice
        • Contact:
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Active, not recruiting
        • Institut für Medizinische Informatik, Biometrie und Epidemiologie
    • Nordrheinwestfalen
      • Essen, Nordrheinwestfalen, Germany, 45147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

population affected by HIV

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection
Time Frame: 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%.
Baseline up to 15 year follow up
Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection
Time Frame: Baseline up to 15 year follow up
Calculation of Odds Ratio
Baseline up to 15 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on cardiovascular risk on amount of atherosclerosis
Time Frame: 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
Baseline up to 15 year follow up
Impact on life quality
Time Frame: 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
Baseline up to 15 year follow up
Impact on life quality
Time Frame: 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
Baseline up to 15 year follow up
Impact on life quality
Time Frame: 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
Baseline up to 15 year follow up
Impact on cardiovascular risk, amount of atherosclerosis and life quality
Time Frame: Baseline up to 15 year follow up
in relation to cardiovascular and antiretroviral medication by calculating the 95%-Confidence interval
Baseline up to 15 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2020

Primary Completion (Anticipated)

October 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-5874-BO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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