Clinical trial NCT04156048: HIV&HEART Aging Study (12,5 Year Follow up)
Official title: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 12,5 Year Follow up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Coronary Disease
Myocardial Infarction
HIV Encephalopathy
Aging
Heart Failure
Keywords: HIV
AIDS
Antiretroviral therapy
Aging
Heart failure
coronary heart disease
myocardial infarction
HIV-associated neurocognitive disorders
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 1809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: population affected by HIV

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 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.

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
* Exercise electrocardiogram
* Exercise Montreal Cognitive Assessment test
* Exercise the Grooved Pegboard test
* Blood collection
* Questionnaire to quality of life and health economics

Eligibility 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

Primary outcomes:
measure: Cardiovascular Diseases in HIV-infected Patients
timeFrame: Baseline up to 12,5 year follow up
Secondary outcomes:
measure: Impact of classic cardiovascular risk factors of coronary artery disease, comorbidities and antiretroviral therapy
timeFrame: Baseline up to 12,5 year follow up
measure: Impact of new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy
timeFrame: Baseline up to 12,5 year follow up
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Institut für Medizinische Informatik, Biometrie und Epidemiologie
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Klinik für Dermatologie
state: Nordrheinwestfalen
city: Bochum
country: Germany
facility: University Hospital of Bochum, Department of Dermatology
state: NRW
city: Duisburg
country: Germany
facility: HIV physician pratice
state: NRW
city: Leipzig
country: Germany
facility: Clinical Coordinating Center Leipzig
state: Sachsen
city: Dortmund
country: Germany
facility: HIV Outpatient Department
Study officials:
affiliation: Departement of dermatology and venerology
name: Stefan Esser, PD, MD
role: PRINCIPAL_INVESTIGATOR
References: