Recruiting

NCT Number: NCT04330287

HIV-HEART Aging Study

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.

Recruiting

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Key information

Conditions

HIV Infections AIDS Dementia Complex Acquired Immunodeficiency Syndrome Aging Blood-Borne Infections Body Weight Body Weight Changes Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Communicable Diseases Coronary Disease Dementia Genital Diseases HIV Encephalopathy Heart Diseases Heart Failure Immune System Diseases Immunologic Deficiency Syndromes Infarction Infections Ischemia Lentivirus Infections Mental Disorders Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases Weight Gain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Essen, Klinik für Dermatologie, Essen, Nordrheinwestfalen, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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%.
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 outcomes

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
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
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
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
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

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Albayrak-Rena

CONTACT

[email protected]

004920172383721 ext. 3631

Stefan Esser, PD MD

CONTACT

[email protected]

00492017233878 ext. -3845

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study 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

Acronym: HIVH

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Apr 1, 2020
Registry last updated: Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed