HIV&HEART Aging Study (12,5 Year Follow up)

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.

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Key information

Conditions

HIV Infections AIDS Dementia Complex Acquired Immunodeficiency Syndrome Aging Blood-Borne Infections 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 Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

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
Exercise electrocardiogram
Exercise Montreal Cognitive Assessment test
Exercise the Grooved Pegboard test
Blood collection
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

Cardiovascular Diseases in HIV-infected Patients

Time frame: Baseline up to 12,5 year follow up

Secondary outcomes

Impact of classic cardiovascular risk factors of coronary artery disease, comorbidities and antiretroviral therapy

Time frame: Baseline up to 12,5 year follow up
Impact of new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy

Time frame: Baseline up to 12,5 year follow up

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: 12,5 Year Follow up

Acronym: HIV&HEART

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Nov 7, 2019
Registry last updated: Feb 5, 2020

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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