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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04156048

Acronym

HIV&HEART

Enrollment

1809

Registered

2019-11-07

Start date

2017-07-03

Completion date

2019-11-06

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Coronary Disease, Heart Failure, HIV Encephalopathy, HIV Infections, Myocardial Infarction

Keywords

HIV, AIDS, Antiretroviral therapy, Aging, Heart failure, coronary heart disease, myocardial infarction, HIV-associated neurocognitive disorders

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cardiovascular Diseases in HIV-infected Patients	Baseline up to 12,5 year follow up

Secondary

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

Countries

Germany

Outcome results