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HIV-HEART Aging Study (HIVH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330287
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : May 15, 2023
Sponsor:
Information provided by (Responsible Party):
Stefan Esser M.D., University Hospital, Essen

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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%.

  2. Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection [ Time Frame: Baseline up to 15 year follow up ]
    Calculation of Odds Ratio


Secondary Outcome Measures :
  1. Impact on cardiovascular risk on amount of atherosclerosis [ Time Frame: Baseline up to 15 year follow up ]
    in relation to age, gender and classic cardiovascular rsik factors inter alia smoking, diabetes, hypercholesterinaemia and arterial hypertension by calculating the relative risk

  2. Impact on life quality [ Time Frame: Baseline up to 15 year follow up ]
    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

  3. Impact on life quality [ Time Frame: Baseline up to 15 year follow up ]
    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

  4. Impact on life quality [ Time Frame: Baseline up to 15 year follow up ]
    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

  5. Impact on cardiovascular risk, amount of atherosclerosis and life quality [ Time Frame: Baseline up to 15 year follow up ]
    in relation to cardiovascular and antiretroviral medication by calculating the 95%-Confidence interval


Biospecimen Retention:   Samples With DNA
stored blood and stool samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
population affected by HIV
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330287


Contacts
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Contact: Stefan Esser, PD MD 00492017233878 ext -3845 stefan.esser@uk-essen.de
Contact: Sarah Albayrak-Rena 004920172383721 ext 3631 sarah.albayrak-rena@uk-essen.de

Locations
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Germany
Institut für Medizinische Informatik, Biometrie und Epidemiologie Active, not recruiting
Essen, Nordrhein-Westfalen, Germany, 45147
Universitätsklinikum Essen, Klinik für Dermatologie Recruiting
Essen, Nordrheinwestfalen, Germany, 45147
Contact: Stefan Esser, MD    0201/723-3878    stefan.esser@uk-essen.de   
Contact: Sarah Albayrak-Rena    0201/723-83721    sarah.albayrak-rena@uk-essen.de   
HIV physician pratice Not yet recruiting
Duisburg, NRW, Germany, 47259
Contact: Friedhelm Kwirant, MD    0049203782173    FKwirant@t-online.de   
University Hospital of Bochum, Department of Dermatology Not yet recruiting
Bochum, Germany, 44791
Contact: Anja Potthoff, MD    ++49 0234/509-1    a.potthoff@klinikum-bochum.de   
HIV Outpatient Department Not yet recruiting
Dortmund, Germany, 44137
Contact: Martin Hower, MD    ++49 95320700    ID.ambulanz@klinikumdo.de   
Contact: Julia Neumann, Study nurse    ++49 95320700    ID.ambulanz@klinikumdo.de   
Sponsors and Collaborators
University Hospital, Essen
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

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Responsible Party: Stefan Esser M.D., Prof. M.D. Head of HPSTD Ambulance, University Hospital, Essen, Principal Investigator, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04330287    
Other Study ID Numbers: 14-5874-BO
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefan Esser M.D., University Hospital, Essen:
HIV
AIDS
Antiretroviral therapy
Aging
Heart Failure
 coronary heart desease
myocardial infarction
HIV-associated neurocognitive disorders
weight gain
Additional relevant MeSH terms:
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Heart Failure
Coronary Disease
Heart Diseases
HIV Infections
AIDS Dementia Complex
Brain Diseases
Myocardial Infarction
Infarction
Weight Gain
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
 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
Central Nervous System Diseases
Nervous System Diseases