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NCT04156048: HIV&HEART

HIV&HEART Aging Study (12,5 Year Follow up)

Completed Last updated 5 February 2020
What this trial tests

trial in HIV Infections in 1,809 participants. Completed in 6 November 2019.

Timeline
3 July 2017
Primary endpoint
31 October 2019
6 November 2019

Quick facts

Lead sponsorUniversity Hospital, Essen
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,809
Start date3 July 2017
Primary completion31 October 2019
Estimated completion6 November 2019
Sites6 locations across Germany

Conditions studied

Sponsor

University Hospital, Essen

Who can join

18 and older, any sex, with HIV Infections or Coronary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 2019 (12,5 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Current insights into transcriptional role(s) for the nutraceutical <i>Withania somnifera</i> in inflammation and aging.
    Saha P, Ajgaonkar S, Maniar D, Sahare S, et al · · 2024 · cited 13× · PMID 38765810 · DOI 10.3389/fnut.2024.1370951

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Other recruiting trials for HIV Infections

Currently open trials in the same condition.

Other University Hospital, Essen trials

Trials by the same sponsor.

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Data sources for this page

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