A Prospective Observational Trial to Determine Cardiovascular Diseases in

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02291081
Study type	Observational
Source	University Hospital, Essen
Contact
Status	Completed
Phase
Start date	October 2014
Completion date	January 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Prospective Observational Trial to Determine Cardiovascular Diseases in HIV-infected Patients — HIV-HEART10

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms