HIVRECOVIHNCT02453919
Register of Cardiovascular Complications Among People Living With HIV
An observational study of HIV and Cardiovascular Diseases, run by Saint Antoine University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Cardiovascular Diseases
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to 31 Dec 2030
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Refusal to give or sign informed consent
- Not associated with a social security regime (no health insurance)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mabel Nuernberg, MPH contact
France1 site, 1 recruiting
- Recruiting
Division of Cardiology, Saint Antoine University Hospital
Paris, 75012
Franck Boccara, MD, PhD, +0033 (0) 1 49 28 20 00, franck.boccara@sat.aphp.fr
Mabel Nuernberg, MPH, MA, +0033 (0) 1 49 28 20 00
About this study
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.
Read the 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.
- Conditions
- HIV, Cardiovascular Diseases
- Keywords
- functional cardiac abnormality, morphologic cardiac abnormality, blood pressure abnormality
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RECOVIH | Complete cardiac examination including echocardiography, ischemia tests, and ambulatory blood pressure monitoring. Collection of clinical information and biochemical laboratory results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Cardiovascular mortality as classified using the 10th revision of the International Classification of Diseases (cardiovascular diagnosis codes I 00-I 99).
Measured: 20 years
Secondary outcomes (3)
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.
Measured: 20 years
Ischemia profile (composite)
Parameters of ischemia tests including - exercise tolerance test, and stress-echocardiography under dobutamine or exercise.
Measured: 20 years
Blood pressure profile (composite)
Parameters from - ambulatory blood pressure monitoring over 24 hours using a Pressure Holter.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startFeb 2010
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Saint Antoine University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franck Boccara, Saint Antoine University Hospital
- Investigators
- Ariel Cohen, MD, PhD, Study chair, Saint Antoine University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453919
- Sponsor's protocol ID
- RECOVIH
- Acronym
- RECOVIH
- Status last verified
- Jan 2024
- First submitted
- 19 May 2015
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21750273Mariano-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.
PubMed 23149821Duong 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.
PubMed 11797181Catzin-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.
PubMed 17258826Mansoor 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.
PubMed 19397399Mondy 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.
PubMed 21217185Reinsch 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.
PubMed 20739268Neumann 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.
PubMed 17666313Reinsch 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.
PubMed 18557952Martinez-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.
PubMed 11083740Hsue 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.
PubMed 19933410Oliviero 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.
PubMed 21160704Lewden 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
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.
PubMed 16878047Dube 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.
PubMed 12942391
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register of Cardiovascular Complications Among People Living With HIV
- ClinicalTrials.gov ID
- NCT02453919
- Acronym / sponsor ID
- RECOVIH / RECOVIH
- Conditions
- HIV, Cardiovascular Diseases
- Keywords
- functional cardiac abnormality, morphologic cardiac abnormality, blood pressure abnormality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Saint Antoine University HospitalUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RECOVIH | – | –Complete cardiac examination including echocardiography, ischemia tests, and ambulatory blood pressure monitoring. Collection of clinical information and biochemical laboratory results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to give or sign informed consent
- Not associated with a social security regime (no health insurance)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
Echocardiographic profile (composite)
Time frame: 20 years
Ischemia profile (composite)
Time frame: 20 years
Blood pressure profile (composite)
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 21750273Wever 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.
- Background: PubMed 23149821Mariano-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.
- Background: PubMed 11797181Duong 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.
- Background: PubMed 17258826Catzin-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.
- Background: PubMed 19397399Mansoor 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.
- Background: PubMed 21217185Mondy 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.
- Background: PubMed 20739268Reinsch 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.
- Background: PubMed 17666313Neumann 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.
- Background: PubMed 18557952Reinsch 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.
- Background: PubMed 11083740Martinez-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.
- Background: PubMed 19933410Hsue 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.
- Background: PubMed 21160704Oliviero 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.
- Individual participant dataSharing planned: Undecided
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mabel Nuernberg, MPH contact
Ariel Cohen, MD, PhD study chair
Saint Antoine University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Cardiovascular Diseases, run by Saint Antoine University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franck Boccara, MD, PhD (+0033 (0) 1 49 28 20 00, franck.boccara@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453919, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.