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

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

Official Title
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HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients

Conditions
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Coronary Heart Disease, Heart Failure, HIV, AIDS, Metabolic Syndrome

Intervention / Treatment
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* Other: Comprehensive non invasive cardiovascular examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regional Ruhrgebiets Cohort<br>HIV-positive patients in the German Ruhr-Region from out-patient clinics of hospitals and HIV-physicians pratices | Other: Comprehensive non invasive cardiovascular examination<br>* Anamnesis with the participian File recherche,Physical examination Documentation of the carciovascular and antiretroviral medical therapy Electrocardiogram Transthoracic echocardiography Exercise electrocardiogram Measuring of the arterial media thickness Exercise Montreal Cognitive Assesment test Exercise the Grooved Pegboard test Blood collection Questionnaire to quality of life and health economics<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Disorders in HIV-infected Patients HIV-HEART | 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. | Baseline up to 5 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Diseases, HIV-Infection, AIDS, Antiretroviral Therapy, Cardiovascular Medication, Risk Factors, coronary heart disease, heart failure, metabolic syndrome