Mitral Valve InsufficiencyPROGRAMNCT01835054
Determinants of the Progression and Outcome of Mitral Regurgitation
An observational study of Mitral Valve Insufficiency, run by Laval University at 4 sites in 3 countries.
Trial summary
Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America and in Europe, and its prevalence is increasing with the aging of the population. Organic Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation are the 2 main categories of MR. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- Blood biomarkers, DNA collection and Echocardiography
- How many people
- 440 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Dec 2008to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort will be selected at primary care clinic
Who may be able to join
- Age > 18 or 21 years (Legal age according to the countries involved in this study)
- Presence of at least mild chronic OMR defined as an ERO ≥10mm2 and/or a regurgitant volume ≥20mL
Who cannot join
- MR due to ischemic heart disease or cardiomyopathy
- > mild mitral stenosis, aortic regurgitation, aortic stenosis or pulmonary stenosis
- previous valve operation
- history of myocardial infarction or angiographycally documented coronary stenosis
- congenital or pericardial heart disease
- endocarditis
Show all 10Show fewer
- contra-indication or inability to exercise
- pregnancy
- Class I or IIa indication for mitral valve operation according to the 2014 ACC/AHA/ESC guidelines
- Typical contraindications to contrast-enhanced MRI (surgery in the last 3 months, defibrillator, pericardial electrodes, brain surgery, aneurysm clipping, neurostimulator, electric stimulation device or magnetically activated, cochlear implant, insulin pump or medication delivery device, Swan-Ganz catheter)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites, 1 recruiting
- Recruiting
University Hospital (CHU) of Brest, Hôpital La Cavale Blanche
Brest, 29609
Florent Le Ven, MD, 33298347391, florent.leven@chu-brest.fr
Florent Le Ven, MD
- Active, not recruiting
University Hospital of Rennes
Rennes, 35033
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Sart Tilman
Liège, 4000
Patrizio Lancellotti, MD, PhD, 32(0)4/366 7194, plancellotti@chu.ulg.ac.be
Patrizio Lancellotti, MD, PhD
Canada1 site, 1 recruiting
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, G1V4G5
Philippe Pibarot, PhD, DVM, 418-656-8711 ext. 5938, Philippe.Pibarot@med.ulaval.ca
Oumhani Toubal, MD, Fellow, 418-656-5711 ext. 2647, oumhani.toubal@criucpq.ulaval.ca
About this study
Official title: Determinants of the Progression and Outcome of Mitral Regurgitation-PROGRAM STUDY
Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America and in Europe, and its prevalence is increasing with the aging of the population. Organic Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation are the 2 main categories of MR. Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the most frequent cause of severe MR leading to surgery in the western world. However, the best current treatment for OMR remains uncertain and controversial. We have obtained preliminary data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at rest, as generally performed during routine clinical exam, does not necessarily reflect the status of MR during patient's daily activities and thereby does not adequately assess the risk of rapid progression and poor outcome in these patients. The objective of this study is to identify the independent predictors of disease progression and outcome in patients with asymptomatic chronic OMR and to develop and validate novel imaging and circulating biomarkers to improve risk stratification and therapeutic decision-making process in patients with chronic asymptomatic primary OMR.
Read the detailed description
Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America and in Europe, and its prevalence is increasing owing to the aging of the population. There are 2 main categories of MR: Organic Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation. Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the most frequent cause of severe MR leading to surgery in the western world. However, the best current treatment for OMR remains uncertain and controversial. This is, in large part, due to the lack of prospective data on the determinants of OMR progression and outcome. Furthermore, we have obtained preliminary data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at rest, as generally performed during routine clinical exam, does not necessarily reflect the status of MR during patient's daily activities and thereby does not adequately assess the risk of rapid progression and poor outcome in these patients.
The general objective of this study is thus: to identify the independent predictors of disease progression and outcome in patients with asymptomatic chronic OMR and to develop and validate novel imaging and circulating biomarkers to improve risk stratification and therapeutic decision-making process in patients with chronic asymptomatic primary OMR.
The specific aims of the study are: (1) To obtain and analyze: a) the dynamic changes in MR severity, pulmonary arterial pressure, and LV function during exercise; b) the maximum exercise capacity; c) the metabolic profile; d) the plasma natriuretic peptides, e) the degree and localization of myocardial fibrosis measured by cardiac magnetic resonance Imaging (MRI); f) the blood markers of myocardial extracellular matrix (ECM) turnover; g) the progression of MR severity and LV dysfunction during follow-up; and h) the occurrence of adverse clinical outcomes (i.e. symptoms, LV dysfunction, atrial fibrillation (Holter ECG), pulmonary hypertension, heart failure, cardiovascular death) during follow-up in a series of 440 patients with at least moderate OMR and no symptoms at baseline. (2) To analyze the valve tissue samples explanted from the patients who will undergo mitral valve repair with quadrangular resection during follow-up in order to document the presence of lipids, inflammation, and expression of metalloproteinases (MMPs). (3) To obtain and analyze the postoperative changes in LV geometry and function, pulmonary arterial pressure, symptoms, and exercise capacity in the subset of patients who will undergo mitral valve surgery during follow-up. (4) To evaluate the usefulness of the exercise induced changes in MR severity, pulmonary arterial pressure, and LV function (i.e. contractile reserve), and of the blood levels of natriuretic peptides and ECM biomarkers for the prediction of rapid progression to LV dysfunction and adverse events. (5) To examine the relationship between the metabolic abnormalities linked to visceral obesity and the progression and outcome of OMR. (6) To determine, among the baseline clinical, echocardiographic, MRI, metabolic, and biomarkers variables, those which are independently associated with the progression of MR severity and LV dysfunction, and the occurrence of adverse clinical outcomes in patients with OMR.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- Blood biomarkers, DNA collection, Echocardiography, Cardiopulmonary exercise testing, Magnetic resonance imaging (MRI)
- Keywords
- Mitral regurgitation, Mitral valve prolapse, Echocardiography, Doppler, Stress echocardiography, Cardiopulmonary exercice testing, Magnetic Resonance Imaging, Cardiac neurohormones, Visceral obesity, Cardiometabolic risk, Risk stratification
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood biomarkersOther
Observational Study using Imaging and Biomarkers
DNA collectionGenetic
Observational Study using Imaging and Biomarkers
EchocardiographyOther
Observational Study using Imaging and Biomarkers
Cardiopulmonary exercise testingOther
Observational Study using Imaging and Biomarkers
Magnetic resonance imaging (MRI)Other
Observational Study using Imaging and Biomarkers
Exercise stress doppler echocardiographyOther
Observational Study using Imaging and Biomarkers
Holter ECGOther
Observational Study using Imaging and Biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Patients with mitral regurgitation | At study entry, patients have 1) a clinical assessment including metabolic risk profile; 2) a blood sample for analysis of metabolic, cardiac neurohormonal blood biomarkers and DNA collection; 3) a complete rest doppler echocardiography; 4) an exercise stress doppler echocardiography; 5) a cardiopulmonary exercise testing; 6) a magnetic resonance Imaging (MRI); 7) a 24-hour Holter ECG.
At follow-up, patients have 1) a clinical events assessment; 2) a blood sample analysis; 3) a resting echocardiography every year; 4) MRI (at preop. evaluation in the subset of patients undergoing surgery); 5) a 24-hour Holter ECG (at 2-year and postop.). Receives: Other: Blood biomarkers; Genetic: DNA collection; Other: Echocardiography; Other: Cardiopulmonary exercise testing; Other: Magnetic resonance imaging (MRI); Other: Exercise stress doppler echocardiography; Other: Holter ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined clinical and echocardiographic endpoint
The primary outcome is the time to occurrence of the first composite end-point: development of symptoms, left ventricular (LV) dysfunction (LV Ejection Fraction<60% and/or LV end diastolic diameter >40mm), ventricular arrhytmia requiring hospitalization, mediaction and/or implantation of defibrillator, atrial fibrillation or flutter, pulmonary arterial hypertension (resting systolic pressure >50mmHg), occurence of pulmonary oedema, congestive heart failure or cardiovascular death.
Measured: Patients will be followed for 10 years
Secondary outcomes (8)
Progression of MR severity
The annualized progression rate of MR severity will be calculated as the difference between effective regurgitant orifice, regurgitant volume, and vena contracta width measured at baseline and those measured at the last follow-up divided by the time between the first and last examinations.
Measured: Patients will be followed for 10 years
Progression of pulmonary arterial hypertension
The annualized progression rate of resting systolic pulmonary arterial pressure will be calculated.
Measured: Patients will be folowed for 10 years
Progression of LV dysfuntion prior to surgery
The annualized progression rate of LVEF, LV end-systolic dimension, and LV myocardial global peak systolic velocities and global longitudinal strain will be calculated.
Measured: Patients will be followed for 10 years
Maximum exercise capacity at baselin and following mitral valve surgery
Maximum exercise capacity at baseline as measured by the percentage of age and gender predicted VO2max. We will determine which are, among the clinical and Doppler-echocardiographic variables, the independent determinants of maximum exercise capacity at baseline. The baseline exercise capacity will also be used as an independent variable, i.e. we will determine if it is an independent predictor of the primary end-point and of the other secondary end-points
Measured: Patients will be followed for 10 years
Composite end-point prior to mitral valve surgery
i.e. follow-up censored at surgery
Measured: Patients will be followed for 10 years
Composite primary end-point after mitral vale surgery
i.e. time zero set at surgery
Measured: Patients will be followed for 10 years
Mitral valve surgery
Motivated by the occurrence of symptoms, LV systolic dysfunction, atrial fibrillation, and/or resting pulmonary pressure > 50 mmHg.
Measured: Patients will be followed for 10 years
Arrhythmic burden
Number and percentage of ventricular ectopic per 24 h, percent time in atrial fibrillation, or flutter per 24 h.
Measured: Patients will be followed for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startDec 2008
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, University Hospital, Brest
- Responsible party
- Principal investigator, Philippe Pibarot, Laval University
- Investigators
- Philippe Pibarot, PhD, DVM, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835054
- Sponsor's protocol ID
- MOP#102737
- Acronym
- PROGRAM
- Status last verified
- Oct 2021
- First submitted
- 16 Apr 2013
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Magne J, Mahjoub H, Pibarot P, Pirlet C, Pierard LA, Lancellotti P. Prognostic importance of exercise brain natriuretic peptide in asymptomatic degenerative mitral regurgitation. Eur J Heart Fail. 2012 Nov;14(11):1293-302. doi: 10.1093/eurjhf/hfs114. Epub 2012 Jul 10.
PubMed 22782970Magne J, Mahjoub H, Pierard LA, O'Connor K, Pirlet C, Pibarot P, Lancellotti P. Prognostic importance of brain natriuretic peptide and left ventricular longitudinal function in asymptomatic degenerative mitral regurgitation. Heart. 2012 Apr;98(7):584-91. doi: 10.1136/heartjnl-2011-301128. Epub 2012 Feb 18.
PubMed 22342982Lancellotti P, Magne J. Stress testing for the evaluation of patients with mitral regurgitation. Curr Opin Cardiol. 2012 Sep;27(5):492-8. doi: 10.1097/HCO.0b013e3283565c3b.
PubMed 22872130Senechal M, Michaud N, Machaalany J, Bernier M, Dubois M, Magne J, Couture C, Mathieu P, Bertrand OF, Voisine P. Relation of mitral valve morphology and motion to mitral regurgitation severity in patients with mitral valve prolapse. Cardiovasc Ultrasound. 2012 Jan 27;10:3. doi: 10.1186/1476-7120-10-3.
PubMed 22284298Van de Heyning CM, Magne J, Vrints CJ, Pierard L, Lancellotti P. The role of multi-imaging modality in primary mitral regurgitation. Eur Heart J Cardiovasc Imaging. 2012 Feb;13(2):139-51. doi: 10.1093/ejechocard/jer257. Epub 2011 Nov 29.
PubMed 22127625Magne J, Lancellotti P, O'Connor K, Van de Heyning CM, Szymanski C, Pierard LA. Prediction of exercise pulmonary hypertension in asymptomatic degenerative mitral regurgitation. J Am Soc Echocardiogr. 2011 Sep;24(9):1004-12. doi: 10.1016/j.echo.2011.04.003. Epub 2011 May 17.
PubMed 21592726Magne J, Lancellotti P, Pierard LA. Exercise-induced changes in degenerative mitral regurgitation. J Am Coll Cardiol. 2010 Jul 20;56(4):300-9. doi: 10.1016/j.jacc.2009.12.073.
PubMed 20633822Magne J, Lancellotti P, Pierard LA. Exercise pulmonary hypertension in asymptomatic degenerative mitral regurgitation. Circulation. 2010 Jul 6;122(1):33-41. doi: 10.1161/CIRCULATIONAHA.110.938241. Epub 2010 Jun 21.
PubMed 20566950Magne J, Mathieu P, Dumesnil JG, Tanne D, Dagenais F, Doyle D, Pibarot P. Impact of prosthesis-patient mismatch on survival after mitral valve replacement. Circulation. 2007 Mar 20;115(11):1417-25. doi: 10.1161/CIRCULATIONAHA.106.631549. Epub 2007 Mar 5.
PubMed 17339554Mascle S, Schnell F, Thebault C, Corbineau H, Laurent M, Hamonic S, Veillard D, Mabo P, Leguerrier A, Donal E. Predictive value of global longitudinal strain in a surgical population of organic mitral regurgitation. J Am Soc Echocardiogr. 2012 Jul;25(7):766-72. doi: 10.1016/j.echo.2012.04.009. Epub 2012 May 19.
PubMed 22609096Donal E, Mascle S, Brunet A, Thebault C, Corbineau H, Laurent M, Leguerrier A, Mabo P. Prediction of left ventricular ejection fraction 6 months after surgical correction of organic mitral regurgitation: the value of exercise echocardiography and deformation imaging. Eur Heart J Cardiovasc Imaging. 2012 Nov;13(11):922-30. doi: 10.1093/ehjci/jes068. Epub 2012 Apr 14.
PubMed 22504944Magne J, Mahjoub H, Dulgheru R, Pibarot P, Pierard LA, Lancellotti P. Left ventricular contractile reserve in asymptomatic primary mitral regurgitation. Eur Heart J. 2014 Jun 21;35(24):1608-16. doi: 10.1093/eurheartj/eht345. Epub 2013 Sep 7.
PubMed 24014387Toubal O, Mahjoub H, Thebault C, Clavel MA, Dahou A, Magne J, O'Connor K, Beaudoin J, Bernier M, Le Ven F, Pibarot P. Increasing Pulmonary Arterial Pressure at Low Level of Exercise in Asymptomatic, Organic Mitral Regurgitation. J Am Coll Cardiol. 2018 Feb 13;71(6):700-701. doi: 10.1016/j.jacc.2017.11.062. No abstract available.
PubMed 29420967Clemenceau A, Berube JC, Belanger P, Gaudreault N, Lamontagne M, Toubal O, Clavel MA, Capoulade R, Mathieu P, Pibarot P, Bosse Y. Deleterious variants in DCHS1 are prevalent in sporadic cases of mitral valve prolapse. Mol Genet Genomic Med. 2018 Jan;6(1):114-120. doi: 10.1002/mgg3.347. Epub 2017 Dec 10.
PubMed 29224215Dupuis M, Mahjoub H, Clavel MA, Cote N, Toubal O, Tastet L, Dumesnil JG, O'Connor K, Dahou A, Thebault C, Belanger C, Beaudoin J, Arsenault M, Bernier M, Pibarot P. Forward Left Ventricular Ejection Fraction: A Simple Risk Marker in Patients With Primary Mitral Regurgitation. J Am Heart Assoc. 2017 Oct 27;6(11):e006309. doi: 10.1161/JAHA.117.006309.
PubMed 29079561
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of the Progression and Outcome of Mitral Regurgitation-PROGRAM STUDY
- ClinicalTrials.gov ID
- NCT01835054
- Acronym / sponsor ID
- PROGRAM / MOP#102737
- Conditions
- Mitral Valve Insufficiency
- Keywords
- Mitral regurgitation, Mitral valve prolapse, Echocardiography, Doppler, Stress echocardiography, Cardiopulmonary exercice testing, Magnetic Resonance Imaging, Cardiac neurohormones, Visceral obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, University Hospital, Brest
- Study start
- Dec 2008
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 18 Apr 2013 (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.
Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America and in Europe, and its prevalence is increasing with the aging of the population. Organic Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation are the 2 main categories of MR. Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the most frequent cause of severe MR leading to surgery in the western world. However, the best current treatment for OMR remains uncertain and controversial. We have obtained preliminary data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at rest, as generally performed during routine clinical exam, does not necessarily reflect the status of MR during patient's daily activities and thereby does not adequately assess the risk of rapid progression and poor outcome in these patients. The objective of this study is to identify the independent predictors of disease progression and outcome in patients with asymptomatic chronic OMR and to develop and validate novel imaging and circulating biomarkers to improve risk stratification and therapeutic decision-making process in patients with chronic asymptomatic primary OMR.
Detailed description
Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America and in Europe, and its prevalence is increasing owing to the aging of the population. There are 2 main categories of MR: Organic Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation. Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the most frequent cause of severe MR leading to surgery in the western world. However, the best current treatment for OMR remains uncertain and controversial. This is, in large part, due to the lack of prospective data on the determinants of OMR progression and outcome. Furthermore, we have obtained preliminary data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at rest, as generally performed during routine clinical exam, does not necessarily reflect the status of MR during patient's daily activities and thereby does not adequately assess the risk of rapid progression and poor outcome in these patients.
The general objective of this study is thus: to identify the independent predictors of disease progression and outcome in patients with asymptomatic chronic OMR and to develop and validate novel imaging and circulating biomarkers to improve risk stratification and therapeutic decision-making process in patients with chronic asymptomatic primary OMR.
The specific aims of the study are: (1) To obtain and analyze: a) the dynamic changes in MR severity, pulmonary arterial pressure, and LV function during exercise; b) the maximum exercise capacity; c) the metabolic profile; d) the plasma natriuretic peptides, e) the degree and localization of myocardial fibrosis measured by cardiac magnetic resonance Imaging (MRI); f) the blood markers of myocardial extracellular matrix (ECM) turnover; g) the progression of MR severity and LV dysfunction during follow-up; and h) the occurrence of adverse clinical outcomes (i.e. symptoms, LV dysfunction, atrial fibrillation (Holter ECG), pulmonary hypertension, heart failure, cardiovascular death) during follow-up in a series of 440 patients with at least moderate OMR and no symptoms at baseline. (2) To analyze the valve tissue samples explanted from the patients who will undergo mitral valve repair with quadrangular resection during follow-up in order to document the presence of lipids, inflammation, and expression of metalloproteinases (MMPs). (3) To obtain and analyze the postoperative changes in LV geometry and function, pulmonary arterial pressure, symptoms, and exercise capacity in the subset of patients who will undergo mitral valve surgery during follow-up. (4) To evaluate the usefulness of the exercise induced changes in MR severity, pulmonary arterial pressure, and LV function (i.e. contractile reserve), and of the blood levels of natriuretic peptides and ECM biomarkers for the prediction of rapid progression to LV dysfunction and adverse events. (5) To examine the relationship between the metabolic abnormalities linked to visceral obesity and the progression and outcome of OMR. (6) To determine, among the baseline clinical, echocardiographic, MRI, metabolic, and biomarkers variables, those which are independently associated with the progression of MR severity and LV dysfunction, and the occurrence of adverse clinical outcomes in patients with OMR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mitral regurgitation | – | Other: Blood biomarkers, Genetic: DNA collection, Other: Echocardiography, Other: Cardiopulmonary exercise testing, Other: Magnetic resonance imaging (MRI), Other: Exercise stress doppler echocardiography, Other: Holter ECGAt study entry, patients have 1) a clinical assessment including metabolic risk profile; 2) a blood sample for analysis of metabolic, cardiac neurohormonal blood biomarkers and DNA collection; 3) a complete rest doppler echocardiography; 4) an exercise stress doppler echocardiography; 5) a cardiopulmonary exercise testing; 6) a magnetic resonance Imaging (MRI); 7) a 24-hour Holter ECG. At follow-up, patients have 1) a clinical events assessment; 2) a blood sample analysis; 3) a resting echocardiography every year; 4) MRI (at preop. evaluation in the subset of patients undergoing surgery); 5) a 24-hour Holter ECG (at 2-year and postop.). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort will be selected at primary care clinic
Key inclusion criteria (2 listed)
- Age > 18 or 21 years (Legal age according to the countries involved in this study)
- Presence of at least mild chronic OMR defined as an ERO ≥10mm2 and/or a regurgitant volume ≥20mL
Key exclusion criteria (10 listed)
- MR due to ischemic heart disease or cardiomyopathy
- > mild mitral stenosis, aortic regurgitation, aortic stenosis or pulmonary stenosis
- previous valve operation
- history of myocardial infarction or angiographycally documented coronary stenosis
- congenital or pericardial heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood biomarkersObservational Study using Imaging and Biomarkers | Other | Patients with mitral regurgitation |
| DNA collectionObservational Study using Imaging and Biomarkers | Genetic | Patients with mitral regurgitation |
| EchocardiographyObservational Study using Imaging and Biomarkers | Other | Patients with mitral regurgitation |
| Cardiopulmonary exercise testingObservational Study using Imaging and Biomarkers | Other | Patients with mitral regurgitation |
| Magnetic resonance imaging (MRI)Observational Study using Imaging and Biomarkers | Other | Patients with mitral regurgitation |
| Exercise stress doppler echocardiographyObservational Study using Imaging and Biomarkers | Other | Patients with mitral regurgitation |
| Holter ECGObservational Study using Imaging and Biomarkers | Other | Patients with mitral regurgitation |
Primary outcome
Combined clinical and echocardiographic endpoint
Time frame: Patients will be followed for 10 years
The primary outcome is the time to occurrence of the first composite end-point: development of symptoms, left ventricular (LV) dysfunction (LV Ejection Fraction<60% and/or LV end diastolic diameter >40mm), ventricular arrhytmia requiring hospitalization, mediaction and/or implantation of defibrillator, atrial fibrillation or flutter, pulmonary arterial hypertension (resting systolic pressure >50mmHg), occurence of pulmonary oedema, congestive heart failure or cardiovascular death.
8 secondary outcomes
Progression of MR severity
Time frame: Patients will be followed for 10 years
Progression of pulmonary arterial hypertension
Time frame: Patients will be folowed for 10 years
Progression of LV dysfuntion prior to surgery
Time frame: Patients will be followed for 10 years
Maximum exercise capacity at baselin and following mitral valve surgery
Time frame: Patients will be followed for 10 years
Composite end-point prior to mitral valve surgery
Time frame: Patients will be followed for 10 years
Composite primary end-point after mitral vale surgery
Time frame: Patients will be followed for 10 years
Mitral valve surgery
Time frame: Patients will be followed for 10 years
Arrhythmic burden
Time frame: Patients will be followed for 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Background: PubMed 22782970Magne J, Mahjoub H, Pibarot P, Pirlet C, Pierard LA, Lancellotti P. Prognostic importance of exercise brain natriuretic peptide in asymptomatic degenerative mitral regurgitation. Eur J Heart Fail. 2012 Nov;14(11):1293-302. doi: 10.1093/eurjhf/hfs114. Epub 2012 Jul 10.
- Background: PubMed 22342982Magne J, Mahjoub H, Pierard LA, O'Connor K, Pirlet C, Pibarot P, Lancellotti P. Prognostic importance of brain natriuretic peptide and left ventricular longitudinal function in asymptomatic degenerative mitral regurgitation. Heart. 2012 Apr;98(7):584-91. doi: 10.1136/heartjnl-2011-301128. Epub 2012 Feb 18.
- Background: PubMed 22872130Lancellotti P, Magne J. Stress testing for the evaluation of patients with mitral regurgitation. Curr Opin Cardiol. 2012 Sep;27(5):492-8. doi: 10.1097/HCO.0b013e3283565c3b.
- Background: PubMed 22284298Senechal M, Michaud N, Machaalany J, Bernier M, Dubois M, Magne J, Couture C, Mathieu P, Bertrand OF, Voisine P. Relation of mitral valve morphology and motion to mitral regurgitation severity in patients with mitral valve prolapse. Cardiovasc Ultrasound. 2012 Jan 27;10:3. doi: 10.1186/1476-7120-10-3.
- Background: PubMed 22127625Van de Heyning CM, Magne J, Vrints CJ, Pierard L, Lancellotti P. The role of multi-imaging modality in primary mitral regurgitation. Eur Heart J Cardiovasc Imaging. 2012 Feb;13(2):139-51. doi: 10.1093/ejechocard/jer257. Epub 2011 Nov 29.
- Background: PubMed 21592726Magne J, Lancellotti P, O'Connor K, Van de Heyning CM, Szymanski C, Pierard LA. Prediction of exercise pulmonary hypertension in asymptomatic degenerative mitral regurgitation. J Am Soc Echocardiogr. 2011 Sep;24(9):1004-12. doi: 10.1016/j.echo.2011.04.003. Epub 2011 May 17.
- Background: PubMed 20633822Magne J, Lancellotti P, Pierard LA. Exercise-induced changes in degenerative mitral regurgitation. J Am Coll Cardiol. 2010 Jul 20;56(4):300-9. doi: 10.1016/j.jacc.2009.12.073.
- Background: PubMed 20566950Magne J, Lancellotti P, Pierard LA. Exercise pulmonary hypertension in asymptomatic degenerative mitral regurgitation. Circulation. 2010 Jul 6;122(1):33-41. doi: 10.1161/CIRCULATIONAHA.110.938241. Epub 2010 Jun 21.
- Background: PubMed 17339554Magne J, Mathieu P, Dumesnil JG, Tanne D, Dagenais F, Doyle D, Pibarot P. Impact of prosthesis-patient mismatch on survival after mitral valve replacement. Circulation. 2007 Mar 20;115(11):1417-25. doi: 10.1161/CIRCULATIONAHA.106.631549. Epub 2007 Mar 5.
- Background: PubMed 22609096Mascle S, Schnell F, Thebault C, Corbineau H, Laurent M, Hamonic S, Veillard D, Mabo P, Leguerrier A, Donal E. Predictive value of global longitudinal strain in a surgical population of organic mitral regurgitation. J Am Soc Echocardiogr. 2012 Jul;25(7):766-72. doi: 10.1016/j.echo.2012.04.009. Epub 2012 May 19.
- Background: PubMed 22504944Donal E, Mascle S, Brunet A, Thebault C, Corbineau H, Laurent M, Leguerrier A, Mabo P. Prediction of left ventricular ejection fraction 6 months after surgical correction of organic mitral regurgitation: the value of exercise echocardiography and deformation imaging. Eur Heart J Cardiovasc Imaging. 2012 Nov;13(11):922-30. doi: 10.1093/ehjci/jes068. Epub 2012 Apr 14.
- Background: PubMed 24014387Magne J, Mahjoub H, Dulgheru R, Pibarot P, Pierard LA, Lancellotti P. Left ventricular contractile reserve in asymptomatic primary mitral regurgitation. Eur Heart J. 2014 Jun 21;35(24):1608-16. doi: 10.1093/eurheartj/eht345. Epub 2013 Sep 7.
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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. This study is not recruiting at the moment.
Philippe Pibarot, PhD, DVM principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Insufficiency, run by Laval University at 4 sites in 3 countries.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Belgium, Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Pibarot, PhD, DVM (418-656-8711 ext. 5938, Philippe.Pibarot@med.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined clinical and echocardiographic endpoint (time frame: Patients will be followed for 10 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 NCT01835054, which also lists 15 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 28 Oct 2021.