Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02453919

Register of Cardiovascular Complications Among People Living With HIV

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Cardiovascular mortality

    Time frame: 20 years

    Cardiovascular mortality as classified using the 10th revision of the International Classification of Diseases (cardiovascular diagnosis codes I 00-I 99).

Secondary outcomes

  1. Echocardiographic profile (composite)

    Time frame: 20 years

    Parameters concerning - left ventricular dysfunction both systolic and diastolic, valvulopathies, pulmonary pressure, pericardial involvement under cross-sectional echocardiography and tissue Doppler imaging.

  2. Ischemia profile (composite)

    Time frame: 20 years

    Parameters of ischemia tests including - exercise tolerance test, and stress-echocardiography under dobutamine or exercise.

  3. Blood pressure profile (composite)

    Time frame: 20 years

    Parameters from - ambulatory blood pressure monitoring over 24 hours using a Pressure Holter.

Study contacts

Contact information is provided by the study sponsor or research team.

Franck Boccara, MD, PhD

CONTACT

[email protected]

+0033 (0) 1 49 28 20 00

Mabel Nuernberg, MPH

CONTACT

+0033 (0) 1 49 28 20 00

Sponsors and collaborators

Lead sponsor

Saint Antoine University Hospital

Other

Registry information

Acronym: RECOVIH

Important dates

Study start
2010
Primary completion
2030
Study completion
2030
First posted
May 27, 2015
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.