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

Completed

• Conditions: HIV Infections; Aging; Myocardial Infarction; Heart Failure; Coronary Disease; HIV Encephalopathy

• Registration Number: NCT04156048
• Lead Sponsor: University Hospital, Essen

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

Study Timeline

• Study Start: 2017-07-03
• Study First Submitted: 2019-10-21
• Primary Completion: 2019-10-31
• Study First Submitted QC: 2019-11-05
• Study Completion: 2019-11-06
• Study First Posted: 2019-11-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1809

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Institut für Medizinische Informatik, Biometrie und Epidemiologie; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

University Hospital of Bochum, Department of Dermatology; 🇩🇪 Bochum, NRW, Germany

HIV Outpatient Department; 🇩🇪 Dortmund, Germany

HIV physician pratice; 🇩🇪 Duisburg, NRW, Germany

Clinical Coordinating Center Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Universitätsklinikum Essen, Klinik für Dermatologie; 🇩🇪 Essen, Nordrheinwestfalen, Germany