Clinical trial NCT02453919: Register of Cardiovascular Complications Among People Living With HIV
Official title: Register of Cardiovascular Complications Among People Living With HIV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Cardiovascular Diseases
Keywords: functional cardiac abnormality
morphologic cardiac abnormality
blood pressure abnormality
Lead sponsor: Saint Antoine University Hospital
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults living with HIV in Paris, France who have a minimum of one additional cardiovascular risk factor and underwent complete cardiac examination at the Cardiac Center of the Saint Antoine University Hospital.

Brief summary: The REgister of cardiovascular COmplications among people living with HIV (RECOVIH) is a single hospital registry of adults living with HIV, with one or more other cardiovascular risk factor, who undergo cardiac examination at the Cardiac Center of the Saint Antoine Hospital.

RECOVIH is an observational and prospective, monocentric (institutional) registry, with anonymized cardiac, biochemical and associated data collection.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Known HIV-1 seropositivity for minimum of six months (confirmed by Elisa and Western Blot)
* Underwent complete cardiac examination (echocardiography, ischemia test, ambulatory blood pressure monitoring) between 2005 and 2010 at the Cardiac Center in the Saint Antoine University Hospital in Paris, France
* Presenting a minimum of two cardiovascular risk factors (HIV and a minimum of one other) according to the AFFSSAPS 2005 and Morlat Report 2013.
* Willing and able to give informed consent to participate in the study

Exclusion Criteria :

* Refusal to give or sign informed consent
* Not associated with a social security regime (no health insurance)

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: 20 years
Secondary outcomes:
measure: Echocardiographic profile (composite)
timeFrame: 20 years
measure: Ischemia profile (composite)
timeFrame: 20 years
measure: Blood pressure profile (composite)
timeFrame: 20 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Division of Cardiology, Saint Antoine University Hospital
Study officials:
affiliation: Saint Antoine University Hospital
name: Ariel Cohen, MD, PhD
role: STUDY_CHAIR
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