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Register of Cardiovascular Complications Among People Living With HIV (RECOVIH)

S

Saint Antoine University Hospital

Status

Enrolling

Conditions

HIV
Cardiovascular Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT02453919
RECOVIH

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

800 participants in 1 patient group

RECOVIH
Description:
Complete cardiac examination including echocardiography, ischemia tests, and ambulatory blood pressure monitoring. Collection of clinical information and biochemical laboratory results.

Trial contacts and locations

1

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Central trial contact

Franck Boccara, MD, PhD; Mabel Nuernberg, MPH

Data sourced from clinicaltrials.gov

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