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

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
HIV-infection, Coronary Heart Disease, Myocardial Infarction, HIV-encephalopathy, Heart Failure, Aging

Intervention / Treatment
-----------------
* Other: Comprehensive non invasive cardiovascular examination


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Diseases an deaths in HIV-infected Patients |  | Baseline up to 10 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of classic cardiovascular risk factors and new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy | 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. | Baseline up to 10 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, AIDS, antiretroviral therapy, aging, heart failure, coronary heart disease, myocardial infarction, HIV-associated neurocognitive disorders