NCT02291081

A Prospective Observational Trial to Determine Cardiovascular Diseases in HIV-infected Patients

A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 10 Year Follow-up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,519 (actual)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The HIV/HEART 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 May 2014 (7,5 year Follow-up) 1481 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

Conditions

• HIV-infection
• Coronary Heart Disease
• Myocardial Infarction
• HIV-encephalopathy
• Heart Failure
• Aging

Interventions

Type	Name	Description
OTHER	Comprehensive non invasive cardiovascular examination	Comprehensive non invasive cardiovascular examination * Anamnesis with the participants * 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

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-11-01
• Completion: 2017-01-01
• First posted: 2014-11-14
• Last updated: 2019-10-01

Locations

7 sites across 1 country: Germany