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

January 28, 2024 updated by: Franck Boccara, Saint Antoine University Hospital

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.

Study Overview

Status

Recruiting

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.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mabel Nuernberg, MPH
  • Phone Number: +0033 (0) 1 49 28 20 00

Study Locations

      • Paris, France, 75012
        • Recruiting
        • Division of Cardiology, Saint Antoine University Hospital
        • Contact:
        • Contact:
          • Mabel Nuernberg, MPH, MA
          • Phone Number: +0033 (0) 1 49 28 20 00

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
RECOVIH

Complete cardiac examination including echocardiography, ischemia tests, and ambulatory blood pressure monitoring.

Collection of clinical information and biochemical laboratory results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 years
Ischemia profile (composite)
Time Frame: 20 years
Parameters of ischemia tests including - exercise tolerance test, and stress-echocardiography under dobutamine or exercise.
20 years
Blood pressure profile (composite)
Time Frame: 20 years
Parameters from - ambulatory blood pressure monitoring over 24 hours using a Pressure Holter.
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Ariel Cohen, MD, PhD, Saint Antoine University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimated)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECOVIH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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