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

Completed

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

• Registration Number: NCT02291081
• Lead Sponsor: University Hospital, Essen

Brief 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

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1519

Inclusion Criteria

• Age > 18 years
• Known HIV-infection
• Written 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 an deaths in HIV-infected Patients	Baseline up to 10 year follow-up

Secondary Outcome Measures

Name	Time	Method
Impact of classic cardiovascular risk factors and new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy	Baseline up to 10 year follow-up	Patients included in the pilot-baseline trial and additionally in the 5 and 7.5 year follow-up will be recruited again for the 10 year follow-up after giving informed consent. After including a total of 1481 patients in the previous phases, now both therapy-naive patients as well as patients being treated with new agents should be included.

Trial Locations

Locations (6)

HIV physician pratice; 🇩🇪 Duisburg, NRW, Germany

City Hospital Dortmund; 🇩🇪 Dortmund, NRW, Germany

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

University Hospital, Department of Dermatology and Venerology; 🇩🇪 Essen, NRW, Germany

HIV physician practice; 🇩🇪 Krefeld, NRW, Germany

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