Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up

Completed

• Conditions: AIDS; Metabolic Syndrome; Coronary Heart Disease; Heart Failure; HIV
• Interventions: Other: Comprehensive non invasive cardiovascular examination

• Registration Number: NCT01667068
• Lead Sponsor: University Hospital, Essen

Brief Summary

Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is rising. Different cohorts are observing an increased risk for cardiovascular diseases in this aging HIV-infected population. Traditional cardiovascular risk factors like smoking are more frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection and metabolic disorders also caused by some antiretroviral substances as special non-traditional risk factors in HIV-infected persons can influence the development of cardiovascular diseases additionally. Therefore new research focus in special risk profile associated with HIV-infection or antiretroviral treatment and prevention for HIV-infected patients is developing.

This present study is an ongoing prospective regional multicenter trial that was conducted to analyse the incidence, prevalence and clinical course of cardiovacular disorders in HIV-infected out-patients.

Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion, pulmonary hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial endocarditis and heart valve disorders. In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians.

Detailed Description

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-17
• Primary Completion: 2014-04
• Status Verified: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1481

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

Arm && Interventions

Group	Intervention	Description
Regional Ruhrgebiets Cohort	Comprehensive non invasive cardiovascular examination	HIV-positive patients in the German Ruhr-Region from out-patient clinics of hospitals and HIV-physicians pratices

Primary Outcome Measures

Name	Time	Method
Cardiovascular Diseases in HIV-infected Patients	Baseline up to 7.5 follow-up to	The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease in HIV-infected patients.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular Disorders in HIV-infected Patients HIV-HEART	Baseline up to 5 years follow-up	Complementary the study also investigates the impact of classic cardiovascular risk factors like gender, age, blood fat and also new HIV-specific risk factors of coronary artery disease like viral-load, CD4-cell count and stage of the infection. The HIV-HEART study will focus the impact of medication including cardiovascular and antiretroviral medication. Further secondary objectives will be examined, including economic costs and the subjectively quality of life of subjects with and without cardiovascular diseases in this patient population.

Trial Locations

Locations (6)

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

University Hospital, West German Heart Center Essen; 🇩🇪 Essen, Germany

HIV Outpatient Department; 🇩🇪 Dortmund, Germany

Health Center; 🇩🇪 Duisburg, Germany

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

Clinical Coordinating Center Leipzig; 🇩🇪 Leipzig, Germany