HIV-HEART Aging Study

NCT ID: NCT04330287

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-11

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Stefan Esser M.D.

Prof. M.D. Head of HPSTD Ambulance, University Hospital, Essen, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsklinikum Essen, Klinik für Dermatologie

Essen, Nordrheinwestfalen, Germany

Site Status RECRUITING

HIV physician pratice

Duisburg, North Rhine-Westphalia, Germany

Site Status NOT_YET_RECRUITING

Institut für Medizinische Informatik, Biometrie und Epidemiologie

Essen, North Rhine-Westphalia, Germany

Site Status ACTIVE_NOT_RECRUITING

University Hospital of Bochum, Department of Dermatology

Bochum, , Germany

Site Status NOT_YET_RECRUITING

HIV Outpatient Department

Dortmund, , Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Stefan Esser, PD MD

Role: CONTACT

00492017233878 ext. -3845

Sarah Albayrak-Rena

Role: CONTACT

004920172383721 ext. 3631

Facility Contacts

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Stefan Esser, MD

Role: primary

0201/723-3878

Sarah Albayrak-Rena

Role: backup

0201/723-83721

Friedhelm Kwirant, MD

Role: primary

0049203782173

Anja Potthoff, MD

Role: primary

++49 0234/509-1

Martin Hower, MD

Role: primary

++49 95320700

Julia Neumann, Study nurse

Role: backup

++49 95320700

References

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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.

Reference Type RESULT
PMID: 30202890 (View on PubMed)

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.

Reference Type RESULT
PMID: 30711264 (View on PubMed)

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.

Reference Type RESULT
PMID: 34028959 (View on PubMed)

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.

Reference Type RESULT
PMID: 36930373 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37675901 (View on PubMed)

Other Identifiers

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14-5874-BO

Identifier Type: -

Identifier Source: org_study_id

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