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Trial record 3 of 3 for:    16878047 [PUBMED-IDS]

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
Sponsor:
Information provided by (Responsible Party):
Franck Boccara, 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.

Condition or disease
HIV

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 [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
RECOVIH

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

Collection of clinical information and biochemical laboratory results.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Ischemia profile (composite) [ Time Frame: 10 years ]
    Parameters of ischemia tests including - exercise tolerance test, and stress-echocardiography under dobutamine or exercise.

  3. Blood pressure profile (composite) [ Time Frame: 10 years ]
    Parameters from - ambulatory blood pressure monitoring over 24 hours using a Pressure Holter.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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)

Information from the National Library of Medicine

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


Locations
France
Division of Cardiology, Saint Antoine University Hospital
Paris, France, 75012
Sponsors and Collaborators
Saint Antoine University Hospital
Investigators
Study Chair: Ariel Cohen, MD, PhD Saint Antoine University Hospital

Publications:
Prise en charge médical des personnes vivants avec le VIH. Recommandations du groupe d'experts. Sous la direction du Pr Philippe Morlat et sous l'égide du CNS et de l'ANRS. www.cns.sante.fr. 2013.
Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Physicians; American Association for Thoracic Surgery; Preventive Cardiovascular Nurses Association; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012 Dec 18;60(24):e44-e164. doi: 10.1016/j.jacc.2012.07.013. Epub 2012 Nov 19.

Responsible Party: Franck Boccara, Professor, Senior Cardiologist, Deputy Director of the Division of Cardiology, Saint Antoine University Hospital
ClinicalTrials.gov Identifier: NCT02453919     History of Changes
Other Study ID Numbers: RECOVIH
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Franck Boccara, Saint Antoine University Hospital:
functional cardiac abnormality
morphologic cardiac abnormality
blood pressure abnormality