HIV-HEART Aging Study

NCT04330287 | Recruiting

• 1 other identifier: 14-5874-BO
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

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

Keywords

HIV; AIDS; Antiretroviral therapy; Aging; Heart Failure; coronary heart desease; myocardial infarction; HIV-associated neurocognitive disorders; weight gain

Outcome Measures

Primary Outcomes (2)

• 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%.

  Baseline up to 15 year follow up

• Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection

  Calculation of Odds Ratio

  Baseline up to 15 year follow up

Secondary Outcomes (5)

• Impact on cardiovascular risk on amount of atherosclerosis

  Baseline up to 15 year follow up

• Impact on life quality

  Baseline up to 15 year follow up

• Impact on life quality

  Baseline up to 15 year follow up

• Impact on life quality

  Baseline up to 15 year follow up

• Impact on cardiovascular risk, amount of atherosclerosis and life quality

  Baseline up to 15 year follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

population affected by HIV

You may qualify if:

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

You may not qualify if:

• Acute cardiovascular disease
• Pregnancy

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (5)

Universitätsklinikum Essen, Klinik für Dermatologie

Essen, Nordrheinwestfalen, 45147, Germany

RECRUITING

HIV physician pratice

Duisburg, North Rhine-Westphalia, 47259, Germany

NOT YET RECRUITING

Institut für Medizinische Informatik, Biometrie und Epidemiologie

Essen, North Rhine-Westphalia, 45147, Germany

ACTIVE NOT RECRUITING

University Hospital of Bochum, Department of Dermatology

Bochum, 44791, Germany

NOT YET RECRUITING

HIV Outpatient Department

Dortmund, 44137, Germany

NOT YET RECRUITING

Related Publications (5)

• 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.

  PMID: 30202890 RESULT

• 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.

  PMID: 30711264 RESULT

• 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.

  PMID: 34028959 RESULT

• 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.

  PMID: 36930373 RESULT

• 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.

  PMID: 37675901 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

stored blood and stool samples

MeSH Terms

Conditions

HIV Infections; Coronary Disease; Myocardial Infarction; AIDS Dementia Complex; Heart Failure; Weight Gain; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Slow Virus Diseases

Central Study Contacts

Stefan Esser, PD MD

CONTACT

00492017233878; stefan.esser@uk-essen.de

Sarah Albayrak-Rena

CONTACT

004920172383721; sarah.albayrak-rena@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. M.D. Head of HPSTD Ambulance, University Hospital, Essen, Principal Investigator

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: May 11, 2020
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

DE (5)