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HIV InfectionsHIVHNCT04330287

HIV-HEART Aging Study

An observational study of HIV Infections and Coronary Disease, run by University Hospital, Essen at 5 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,000 participants
Where
5 sitesGermany
Study dates
11 May 2020to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: population affected by HIV

Who may be able to join

  • Age > 18 years
  • Known HIV-infection
  • Signed informed consent

Who cannot join

  • Acute cardiovascular disease
  • Unstable hemodynamic status in the three weeks before inclusion
  • Pregnancy

Trial locations and contacts

5 sites in 1 country.

Stefan Esser, PD MD contact

00492017233878 ext. -3845

stefan.esser@uk-essen.de

Sarah Albayrak-Rena contact

004920172383721 ext. 3631

sarah.albayrak-rena@uk-essen.de

5 sites in 1 country

Germany5 sites, 4 recruiting

  • University Hospital of Bochum, Department of Dermatology

    Bochum, 44791

    Anja Potthoff, MD, ++49 0234/509-1, a.potthoff@klinikum-bochum.de

    Not yet recruiting

  • HIV Outpatient Department

    Dortmund, 44137

    Martin Hower, MD, ++49 95320700, ID.ambulanz@klinikumdo.de

    Julia Neumann, Study nurse, ++49 95320700, ID.ambulanz@klinikumdo.de

    Not yet recruiting

  • HIV physician pratice

    Duisburg, North Rhine-Westphalia, 47259

    Friedhelm Kwirant, MD, 0049203782173, FKwirant@t-online.de

    Not yet recruiting

  • Universitätsklinikum Essen, Klinik für Dermatologie

    Essen, Nordrheinwestfalen, 45147

    Stefan Esser, MD, 0201/723-3878, stefan.esser@uk-essen.de

    Sarah Albayrak-Rena, 0201/723-83721, sarah.albayrak-rena@uk-essen.de

    Recruiting

  • Institut für Medizinische Informatik, Biometrie und Epidemiologie

    Essen, North Rhine-Westphalia, 45147

    Active, not recruiting

Other trials in Germany

About this study

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

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.

Read the 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
Keywords
HIV, AIDS, Antiretroviral therapy, Aging, Heart Failure, coronary heart desease, myocardial infarction, HIV-associated neurocognitive disorders, weight gain
Medical subject headings
HIV Infections, Coronary Disease, Myocardial Infarction, AIDS Dementia Complex, Heart Failure, Weight Gain, Acquired Immunodeficiency Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: 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

    Measured: Baseline up to 15 year follow up

Secondary outcomes (5)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline up to 15 year follow up

  5. Impact on cardiovascular risk, amount of atherosclerosis and life quality

    in relation to cardiovascular and antiretroviral medication by calculating the 95%-Confidence interval

    Measured: Baseline up to 15 year follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2020
  2. Study start11 May 2020
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04330287
Sponsor's protocol ID
14-5874-BO
Acronym
HIVH
Status last verified
Jul 2024
First submitted
30 Mar 2020
Last updated
30 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kehrmann J, Menzel J, Saeedghalati M, Obeid R, Schulze C, Holzendorf V, Farahpour F, Reinsch N, Klein-Hitpass L, Streeck H, Hoffmann D, Buer J, Esser S; HIV-HEART Study Group. Gut Microbiota in Human Immunodeficiency Virus-Infected Individuals Linked to Coronary Heart Disease. J Infect Dis. 2019 Jan 9;219(3):497-508. doi: 10.1093/infdis/jiy524.

    PubMed 30202890

  • Reinsch N, Streeck H, Holzendorf V, Schulze C, Neumann T, Brockmeyer NH, Kehrmann J, Schadendorf D, Esser S; HIV HEART Study Group. B-type natriuretic peptides for the prediction of cardiovascular events and mortality in patients living with HIV: Results from the HIV-HEART study. Int J Cardiol. 2019 Apr 15;281:127-132. doi: 10.1016/j.ijcard.2019.01.066. Epub 2019 Jan 23.

    PubMed 30711264

  • Schulz CA, Mavarani L, Reinsch N, Albayrak-Rena S, Potthoff A, Brockmeyer N, Hower M, Erbel R, Jockel KH, Schmidt B, Esser S; HIV HEART Aging Study Group and Heinz Nixdorf Recall Investigative Group. Prediction of future cardiovascular events by Framingham, SCORE and asCVD risk scores is less accurate in HIV-positive individuals from the HIV-HEART Study compared with the general population. HIV Med. 2021 Sep;22(8):732-741. doi: 10.1111/hiv.13124. Epub 2021 May 24.

    PubMed 34028959

  • Mavarani L, Albayrak-Rena S, Potthoff A, Hower M, Dolff S, Sammet S, Maischack F, Schadendorf D, Schmidt B, Esser S; HIV HEART AGING Study. Changes in body mass index, weight, and waist-to-hip ratio over five years in HIV-positive individuals in the HIV Heart Aging Study compared to the general population. Infection. 2023 Aug;51(4):1081-1091. doi: 10.1007/s15010-023-02009-8. Epub 2023 Mar 17.

    PubMed 36930373

  • Mavarani L, Reinsch N, Albayrak-Rena S, Potthoff A, Hower M, Dolff S, Schadendorf D, Jockel KH, Schmidt B, Esser S. The Association of HIV-Specific Risk Factors with Cardiovascular Events in Addition to Traditional Risk Factors in People Living with HIV. AIDS Res Hum Retroviruses. 2024 Apr;40(4):235-245. doi: 10.1089/AID.2023.0055. Epub 2023 Oct 9.

    PubMed 37675901

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Coronary Disease, run by University Hospital, Essen at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stefan Esser, PD MD (00492017233878 ext. -3845, stefan.esser@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04330287, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

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