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HIV-HEART Aging Study

HIV-HEART Aging Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Eligibility

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 details
    HIV Infections
    Coronary Disease
    Myocardial Infarction
    HIV Encephalopathy
    Aging
    Heart Failure
    Weight Gain

NCT04330287

University Hospital, Essen

26 January 2024

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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