Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up
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|ClinicalTrials.gov Identifier: NCT01667068|
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : October 28, 2014
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.
|Condition or disease||Intervention/treatment|
|Coronary Heart Disease Heart Failure HIV AIDS Metabolic Syndrome||Other: Comprehensive non invasive cardiovascular examination|
|Study Type :||Observational|
|Actual Enrollment :||1481 participants|
|Official Title:||HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients|
|Study Start Date :||April 2012|
|Primary Completion Date :||April 2014|
|Study Completion Date :||October 2014|
Regional Ruhrgebiets Cohort
HIV-positive patients in the German Ruhr-Region from out-patient clinics of hospitals and HIV-physicians pratices
Other: Comprehensive non invasive cardiovascular examination
- Cardiovascular Diseases in HIV-infected Patients [ Time Frame: 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.
- Cardiovascular Disorders in HIV-infected Patients HIV-HEART [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667068
|University Hospital of Bochum, Department of Dermatology|
|Bochum, Germany, 44791|
|HIV Outpatient Department|
|Dortmund, Germany, 44137|
|Duisburg, Germany, 47249|
|University Hospital, Department of Dermatology and Venerology|
|Essen, Germany, 45147|
|University Hospital, West German Heart Center Essen|
|Essen, Germany, 45147|
|Clinical Coordinating Center Leipzig|
|Leipzig, Germany, 04107|
|Principal Investigator:||Stefan Esser, MD||University Hospital, Essen|
|Principal Investigator:||Till Neumann Neumann, MD||University Hospital, Essen|