Register of Cardiovascular Complications Among People Living With HIV (RECOVIH)
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|ClinicalTrials.gov Identifier: NCT02453919|
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : April 18, 2018
|Condition or disease|
This hospital-based cardiac registry maintains data from all non-opposing adults living with HIV, with one or more other cardiac risk factor, who undergo complete cardiac examination at the Cardiac Center at the Saint Antoine Hospital.
RECOVIH registry -
The focus of this hospital-based cardiac registry is on clinical care, particularly on risk stratification, of adults living with HIV.
The register was designed to evaluate echocardiographic, coronarographic, and blood pressure abnormalities among people living with HIV (PLWH).
The primary goal of this single hospital registry is the improvement of patient care, especially risk stratification, by medical audit-type evaluation of cardiac tests and outcomes.
RECOVIH data and research -
Cardiac, biochemical, and associated data collected by this single hospital registry are also used as a source of data for some types of research. This research is particularly timely and relevant as currently little scientific evidence exists describing optimal cardiac care, and risk stratification, for adults living with HIV.
The primary goal of research using RECOVIH data is the quantification of morphologic and functional cardiac abnormalities and blood pressure abnormalities.
The secondary research goal is the identification and description of key aspects of the relationship between HIV, cardiovascular diseases (CVD), and CVD risk factors. Exploration of this complex relationship may help identify and describe the impact of chronic HIV related infection and inflammation, antiretroviral use (ARV), and individual health risks on the development and course of morphologic and functional cardiac abnormalities and blood pressure levels.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Register of Cardiovascular Complications Among People Living With HIV|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||March 30, 2018|
Complete cardiac examination including echocardiography, ischemia tests, and ambulatory blood pressure monitoring.
Collection of clinical information and biochemical laboratory results.
- Cardiovascular mortality [ Time Frame: 10 years ]Cardiovascular mortality as classified using the 10th revision of the International Classification of Diseases (cardiovascular diagnosis codes I 00-I 99).
- Echocardiographic profile (composite) [ Time Frame: 10 years ]Parameters concerning - left ventricular dysfunction both systolic and diastolic, valvulopathies, pulmonary pressure, pericardial involvement under cross-sectional echocardiography and tissue Doppler imaging.
- Ischemia profile (composite) [ Time Frame: 10 years ]Parameters of ischemia tests including - exercise tolerance test, and stress-echocardiography under dobutamine or exercise.
- Blood pressure profile (composite) [ Time Frame: 10 years ]Parameters from - ambulatory blood pressure monitoring over 24 hours using a Pressure Holter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453919
|Division of Cardiology, Saint Antoine University Hospital|
|Paris, France, 75012|
|Study Chair:||Ariel Cohen, MD, PhD||Saint Antoine University Hospital|