Register of Cardiovascular Complications Among People Living With HIV

Cardiovascular Diseases Clinical Trial

— RECOVIH  

Official title:

Register of Cardiovascular Complications Among People Living With HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02453919
• Other study ID #: RECOVIH
• Status: Recruiting
• Start date: February 2010
• Est. completion date: December 31, 2030

Study information

• Verified date: January 2024
• Source: Saint Antoine University Hospital
• Contact: Franck Boccara, MD, PhD
• Phone: +0033 (0) 1 49 28 20 00
• Email: franck.boccara[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• HIV

Locations

Country	Name	City	State
France	Division of Cardiology, Saint Antoine University Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Saint Antoine University Hospital

Country where clinical trial is conducted

France, 

References & Publications (26)

Aberg JA, Gallant JE, Ghanem KG, Emmanuel P, Zingman BS, Horberg MA; Infectious Diseases Society of America. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV medicine association of the Infectious Diseases Society of America. Clin Infect Dis. 2014 Jan;58(1):e1-34. doi: 10.1093/cid/cit665. Epub 2013 Nov 13. — View Citation

Arbab-Zadeh A. Stress testing and non-invasive coronary angiography in patients with suspected coronary artery disease: time for a new paradigm. Heart Int. 2012 Feb 3;7(1):e2. doi: 10.4081/hi.2012.e2. Epub 2012 Feb 8. — View Citation

Catzin-Kuhlmann A, Orea-Tejeda A, Castillo-Martinez L, Colin-Ramirez E, Asz D, Aguirre VH, Herrera LE, Valles V, Aguilar-Salinas CA, Sierra J, Calva JJ. Human immunodeficiency virus-infected subjects have no altered myocardial perfusion. Int J Cardiol. 2007 Oct 31;122(1):90-2. doi: 10.1016/j.ijcard.2006.11.040. Epub 2007 Jan 26. — View Citation

Dube MP, Stein JH, Aberg JA, Fichtenbaum CJ, Gerber JG, Tashima KT, Henry WK, Currier JS, Sprecher D, Glesby MJ; Adult AIDS Clinical Trials Group Cardiovascular Subcommittee; HIV Medical Association of the Infectious Disease Society of America. Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medical Association of the Infectious Disease Society of America and the Adult AIDS Clinical Trials Group. Clin Infect Dis. 2003 Sep 1;37(5):613-27. doi: 10.1086/378131. Epub 2003 Aug 15. No abstract available. — View Citation

Duong M, Cottin Y, Piroth L, Fargeot A, Lhuiller I, Bobillier M, Grappin M, Buisson M, Zeller M, Chavanet P, Wolf JE, Portier H. Exercise stress testing for detection of silent myocardial ischemia in human immunodeficiency virus-infected patients receiving antiretroviral therapy. Clin Infect Dis. 2002 Feb 15;34(4):523-8. doi: 10.1086/338398. Epub 2002 Jan 2. — View Citation

El Hattaoui M, Charei N, Boumzebra D, Aajly L, Fadouach S. [Prevalence of cardiomyopathy in HIV infection: prospective study on 158 HIV patients]. Med Mal Infect. 2008 Jul;38(7):387-91. doi: 10.1016/j.medmal.2008.03.006. Epub 2008 Jun 25. French. — View Citation

European Association for Cardiovascular Prevention & Rehabilitation; Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28. — View Citation

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. No abstract available. — View Citation

Hsue PY, Hunt PW, Ho JE, Farah HH, Schnell A, Hoh R, Martin JN, Deeks SG, Bolger AF. Impact of HIV infection on diastolic function and left ventricular mass. Circ Heart Fail. 2010 Jan;3(1):132-9. doi: 10.1161/CIRCHEARTFAILURE.109.854943. Epub 2009 Nov 20. — View Citation

Karavidas A, Foukarakis M, Lazaros G, Chini M, Fotiadis I, Arapi S, Gialernios T, Potamitis N, Gargalianos P, Matsakas E, Stefanadis C. Assessment of cardiac function with Doppler tissue imaging in asymptomatic HIV-infected patients. Int J STD AIDS. 2008 Apr;19(4):227-31. doi: 10.1258/ijsa.2007.007225. — View Citation

Lang S, Mary-Krause M, Cotte L, Gilquin J, Partisani M, Simon A, Boccara F, Costagliola D; Clinical Epidemiology Group of the French Hospital Database on HIV. Impact of individual antiretroviral drugs on the risk of myocardial infarction in human immunodeficiency virus-infected patients: a case-control study nested within the French Hospital Database on HIV ANRS cohort CO4. Arch Intern Med. 2010 Jul 26;170(14):1228-38. doi: 10.1001/archinternmed.2010.197. — View Citation

Lewden C, May T, Rosenthal E, Burty C, Bonnet F, Costagliola D, Jougla E, Semaille C, Morlat P, Salmon D, Cacoub P, Chene G, Group AEMS, Mortavic. Changes in causes of death among adults infected by hiv between 2000 and 2005: The

Lundgren JD, Battegay M, Behrens G, De Wit S, Guaraldi G, Katlama C, Martinez E, Nair D, Powderly WG, Reiss P, Sutinen J, Vigano A; EACS Executive Committee. European AIDS Clinical Society (EACS) guidelines on the prevention and management of metabolic diseases in HIV. HIV Med. 2008 Feb;9(2):72-81. doi: 10.1111/j.1468-1293.2007.00534.x. — View Citation

Mansoor A, Golub ET, Dehovitz J, Anastos K, Kaplan RC, Lazar JM. The association of HIV infection with left ventricular mass/hypertrophy. AIDS Res Hum Retroviruses. 2009 May;25(5):475-81. doi: 10.1089/aid.2008.0170. — View Citation

Mariano-Goulart D, Jacquet JM, Molinari N, Bourdon A, Benkiran M, Sainmont M, Cornillet L, Macia JC, Reynes J, Ben Bouallegue F. Should HIV-infected patients be screened for silent myocardial ischaemia using gated myocardial perfusion SPECT? Eur J Nucl Med Mol Imaging. 2013 Jan;40(2):271-9. doi: 10.1007/s00259-012-2262-1. Epub 2012 Nov 14. — View Citation

Martinez-Garcia T, Sobrino JM, Pujol E, Galvez J, Benitez E, Giron-Gonzalez JA. Ventricular mass and diastolic function in patients infected by the human immunodeficiency virus. Heart. 2000 Dec;84(6):620-4. doi: 10.1136/heart.84.6.620. — View Citation

Mondy KE, Gottdiener J, Overton ET, Henry K, Bush T, Conley L, Hammer J, Carpenter CC, Kojic E, Patel P, Brooks JT; SUN Study Investigators. High Prevalence of Echocardiographic Abnormalities among HIV-infected Persons in the Era of Highly Active Antiretroviral Therapy. Clin Infect Dis. 2011 Feb 1;52(3):378-86. doi: 10.1093/cid/ciq066. Epub 2010 Dec 9. — View Citation

Nayak G, Ferguson M, Tribble DR, Porter CK, Rapena R, Marchicelli M, Decker CF. Cardiac diastolic dysfunction is prevalent in HIV-infected patients. AIDS Patient Care STDS. 2009 Apr;23(4):231-8. doi: 10.1089/apc.2008.0142. — View Citation

Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Muller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Loffler M, Maisch B, Mugge A, Wasem J, Gerken G, Brockmeyer NH, Erbel R; HIV-HEART Study Investigative Group. Prevalence and natural history of heart failure in outpatient HIV-infected subjects: rationale and design of the HIV-HEART study. Eur J Med Res. 2007 Jun 27;12(6):243-8. — View Citation

Oliviero U, Bonadies G, Bosso G, Foggia M, Apuzzi V, Cotugno M, Valvano A, Leonardi E, Borgia G, Castello G, Napoli R, Sacca L. Impaired diastolic function in naive untreated human immunodeficiency virus infected patients. World J Cardiol. 2010 Apr 26;2(4):98-103. doi: 10.4330/wjc.v2.i4.98. — View Citation

Palella FJ Jr, Baker RK, Moorman AC, Chmiel JS, Wood KC, Brooks JT, Holmberg SD; HIV Outpatient Study Investigators. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006 Sep;43(1):27-34. doi: 10.1097/01.qai.0000233310.90484.16. — View Citation

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.

Reinsch N, Buhr C, Krings P, Kaelsch H, Kahlert P, Konorza T, Neumann T, Erbel R; Competence Network of Heart Failure. Effect of gender and highly active antiretroviral therapy on HIV-related pulmonary arterial hypertension: results of the HIV-HEART Study. HIV Med. 2008 Aug;9(7):550-6. doi: 10.1111/j.1468-1293.2008.00602.x. Epub 2008 Jun 28. — View Citation

Reinsch N, Neuhaus K, Esser S, Potthoff A, Hower M, Brockmeyer NH, Erbel R, Neumann T; German Competence Network for Heart Failure; German Competence Network for HIV AIDS. Prevalence of cardiac diastolic dysfunction in HIV-infected patients: results of the HIV-HEART study. HIV Clin Trials. 2010 May-Jun;11(3):156-62. doi: 10.1310/hct1103-156. — View Citation

Thoni GJ, Schuster I, Walther G, Nottin S, Vinet A, Boccara F, Mauboussin JM, Rouanet I, Ederhy S, Dauzat M, Messner-Pellenc P, Obert P. Silent cardiac dysfunction and exercise intolerance in HIV+ men receiving combined antiretroviral therapies. AIDS. 2008 Nov 30;22(18):2537-40. doi: 10.1097/QAD.0b013e328319806d. — View Citation

Wever Pinzon O, Silva Enciso J, Romero J, Makani H, Fefer J, Gandhi V, Bangalore S, Chaudhry FA. Risk stratification and prognosis of human immunodeficiency virus-infected patients with known or suspected coronary artery disease referred for stress echocardiography. Circ Cardiovasc Imaging. 2011 Jul;4(4):363-70. doi: 10.1161/CIRCIMAGING.110.961060. Epub 2011 Jul 12. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality	Cardiovascular mortality as classified using the 10th revision of the International Classification of Diseases (cardiovascular diagnosis codes I 00-I 99).	20 years
Secondary	Echocardiographic profile (composite)	Parameters concerning - left ventricular dysfunction both systolic and diastolic, valvulopathies, pulmonary pressure, pericardial involvement under cross-sectional echocardiography and tissue Doppler imaging.	20 years
Secondary	Ischemia profile (composite)	Parameters of ischemia tests including - exercise tolerance test, and stress-echocardiography under dobutamine or exercise.	20 years
Secondary	Blood pressure profile (composite)	Parameters from - ambulatory blood pressure monitoring over 24 hours using a Pressure Holter.	20 years