Mitral Valve RegurgitationHEMINCT02961647
Hemodynamic Stress Test in Severe Mitral Regurgitation (HEMI)
An observational study of Mitral Valve Regurgitation, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The preferred treatment of organic mitral regurgitation (MR) is mitral valve repair. Optimally this should be timed so late that it commensurate with the risk of surgery and before irreversibly damage of the heart and pulmonary vessels. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Mitral valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to Sep 2017
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the research project the investigators will examine 80 patients with severe MR, of which 40 do not experience symptoms.
Who may be able to join
- Organic mitral valve regurgitation with effective regurgitation orifice (ERO)>0.3 cm2
- Age > 18 years
- Left ventricular ejection fraction (LVEF) > 60% assessed by echocardiography
- Signed informed consent
Who cannot join
- Poor echocardiographic window
- Inability to perform bicycle exercise testing
- Ischemic or functional (secondary) mitral valve regurgitation
- Chronic atrial fibrillation/flutter
- Hemodynamic significant aortic valve disease assessed by echocardiography.
- Treatment with oral anticoagulants
Trial locations and contacts
1 site in 1 country.
Jacob Møller, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiology, Odense University Hospital
Odense, Odense C, 5000
Rine Bakkestrøm, MD, 0045 31164004, rine.bakkestroem@rsyd.dk
About this study
Official title: Invasive Hemodynamic Stress Test in Symptomatic and Asymptomatic Mitral Regurgitation
The preferred treatment of organic mitral regurgitation (MR) is mitral valve repair. Optimally this should be timed so late that it commensurate with the risk of surgery and before irreversibly damage of the heart and pulmonary vessels. The aim is to obtain an understanding of the differences between the symptomatic and asymptomatic patient.
The study will test
Read more
A: Symptomatic organic MR is characterized by higher filling pressure, and higher stroke work during physical strain compared with asymptomatic MR.
B: The extent of myocardial fibrosis is associated with filling pressure and cardiac index 1 year after mitral valve repair.
C: Filling pressure can be estimated non-invasively by echocardiography. To test this 40 patients with asymptomatic MR and 40 symptomatic will undergo a stress echocardiography with simultaneous echocardiography and invasive measurement of central hemodynamics. In addition a pulmonary function test and cardiac MRI will be performed.
Read the detailed description
Background
Degenerative mitral valve disease is the most common cause of organic mitral regurgitation in the Western World. The preferred treatment of organic mitral regurgitation is mitral valve repair. Optimally this should be timed so late that it commensurate with the risk of surgery and before irreversibly damage of the heart and pulmonary vessels. According to the current guidelines mitral valve surgery is indicated in symptomatic patients with severe MR or in presence of known risk factors. The optimal timing of surgery is still controversial in the asymptomatic patients without risk factors.
The overall aim of the present study is to obtain a better understanding of the central hemodynamics at rest and during physical exercise in both symptomatic and asymptomatic patients with organic mitral regurgitation, the relation to neurohormonal activation and myocardial fibrosis, and to identify noninvasive echocardiographic measures suitable for estimation of this.
A epidemiologic sub-study aims to asses whether MR is associated with inherence, as familial clustering of mitral regurgitation earlier has been suggested based only mainly on small observational studies, and case reports.
Methods
The study will test
A: Symptomatic organic MR is characterized by higher filling pressure, and higher stroke work during physical strain compared with asymptomatic MR.
B: The extent of myocardial fibrosis is associated with filling pressure and cardiac index 1 year after mitral valve repair.
C: Filling pressure can be estimated non-invasively by echocardiography.
To test this 40 patients with asymptomatic MR and 40 patients with symptomatic MR will undergo a stress echocardiography with simultaneous echocardiography and invasive measurement of central hemodynamics. In symptomatic patients that undergo surgery, the examination will be repeated 1 year after the surgical mitral valve repair.
In addition pulmonary function test, maximal oxygen consumption test and cardiac MRI will be performed.
The Danish Twin Registry and The Danish National Patient Registry will be used to identify twins with MR. The hypothesis is that the concordance rate is higher in monozygotic twins compared to dizygotic twins.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Mitral valve repair
- Keywords
- Hemodynamic stress test, Surgical intervention
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve repairProcedure or surgery
The intervention is NOT related to the study design. It is a description of patients undergoing surgery vs. not undergoing surgery and this decision is made according to current guidelines (patients are not randomized).
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic patients | Patients with asymptomatic severe mitral valve regurgitation not undergoing surgical repair of the valve. | |
| Symptomatic patients | Patients with symptomatic severe mitral valve regurgitation undergoing surgical repair of the valve. Receives: Procedure: Mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary artery wedge pressure
Measured: One year after mitral valve replacement
Secondary outcomes (2)
Extent of myocardial fibrosis
Measured: One year after mitral valve replacement
Maximal oxygen consumption
Measured: One year after mitral valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startOct 2014
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation, University of Southern Denmark
- Responsible party
- Principal investigator, Rine Bakkestrøm, Odense University Hospital
- Investigators
- Jacob Møller, Professor, Principal investigator, Department of Cardiology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961647
- Sponsor's protocol ID
- A5130
- Acronym
- HEMI
- Status last verified
- May 2017
- First submitted
- 6 Oct 2016
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS); Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012 Oct;33(19):2451-96. doi: 10.1093/eurheartj/ehs109. Epub 2012 Aug 24. No abstract available.
PubMed 22922415Bonow RO. Chronic mitral regurgitation and aortic regurgitation: have indications for surgery changed? J Am Coll Cardiol. 2013 Feb 19;61(7):693-701. doi: 10.1016/j.jacc.2012.08.1025. Epub 2012 Dec 19.
PubMed 23265342Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.
PubMed 15745978Suri RM, Vanoverschelde JL, Grigioni F, Schaff HV, Tribouilloy C, Avierinos JF, Barbieri A, Pasquet A, Huebner M, Rusinaru D, Russo A, Michelena HI, Enriquez-Sarano M. Association between early surgical intervention vs watchful waiting and outcomes for mitral regurgitation due to flail mitral valve leaflets. JAMA. 2013 Aug 14;310(6):609-16. doi: 10.1001/jama.2013.8643.
PubMed 23942679Naji P, Griffin BP, Asfahan F, Barr T, Rodriguez LL, Grimm R, Agarwal S, Stewart WJ, Mihaljevic T, Gillinov AM, Desai MY. Predictors of long-term outcomes in patients with significant myxomatous mitral regurgitation undergoing exercise echocardiography. Circulation. 2014 Mar 25;129(12):1310-9. doi: 10.1161/CIRCULATIONAHA.113.005287. Epub 2014 Jan 6.
PubMed 24396041Magne 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 22782970Ersboll M, Valeur N, Mogensen UM, Andersen MJ, Moller JE, Velazquez EJ, Hassager C, Sogaard P, Kober L. Prediction of all-cause mortality and heart failure admissions from global left ventricular longitudinal strain in patients with acute myocardial infarction and preserved left ventricular ejection fraction. J Am Coll Cardiol. 2013 Jun 11;61(23):2365-73. doi: 10.1016/j.jacc.2013.02.061. Epub 2013 Apr 3.
PubMed 23563128Witkowski TG, Thomas JD, Debonnaire PJ, Delgado V, Hoke U, Ewe SH, Versteegh MI, Holman ER, Schalij MJ, Bax JJ, Klautz RJ, Marsan NA. Global longitudinal strain predicts left ventricular dysfunction after mitral valve repair. Eur Heart J Cardiovasc Imaging. 2013 Jan;14(1):69-76. doi: 10.1093/ehjci/jes155. Epub 2012 Jul 29.
PubMed 22848021Dalsgaard M, Kjaergaard J, Pecini R, Iversen KK, Kober L, Moller JE, Grande P, Clemmensen P, Hassager C. Left ventricular filling pressure estimation at rest and during exercise in patients with severe aortic valve stenosis: comparison of echocardiographic and invasive measurements. J Am Soc Echocardiogr. 2009 Apr;22(4):343-9. doi: 10.1016/j.echo.2009.01.007. Epub 2009 Mar 9.
PubMed 19269785Andersen MJ, Ersboll M, Axelsson A, Gustafsson F, Hassager C, Kober L, Borlaug BA, Boesgaard S, Skovgaard LT, Moller JE. Sildenafil and diastolic dysfunction after acute myocardial infarction in patients with preserved ejection fraction: the Sildenafil and Diastolic Dysfunction After Acute Myocardial Infarction (SIDAMI) trial. Circulation. 2013 Mar 19;127(11):1200-8. doi: 10.1161/CIRCULATIONAHA.112.000056. Epub 2013 Feb 13.
PubMed 23406672Andersen MJ, Wolsk E, Bakkestrom R, Christensen N, Carter-Storch R, Omar M, Dahl JS, Frederiksen PH, Borlaug B, Gustafsson F, Hassager C, Moller JE. Pressure-flow responses to exercise in aortic stenosis, mitral regurgitation and diastolic dysfunction. Heart. 2022 Nov 10;108(23):1895-1903. doi: 10.1136/heartjnl-2022-321204.
PubMed 36356959Bakkestrom R, Banke A, Pecini R, Irmukhamedov A, Nielsen SK, Andersen MJ, Borlaug BA, Moller JE. Cardiac remodelling and haemodynamic characteristics in primary mitral valve regurgitation. Open Heart. 2018 Dec 16;5(2):e000919. doi: 10.1136/openhrt-2018-000919. eCollection 2018.
PubMed 30613416Bakkestrom R, Banke A, Christensen NL, Pecini R, Irmukhamedov A, Andersen M, Borlaug BA, Moller JE. Hemodynamic Characteristics in Significant Symptomatic and Asymptomatic Primary Mitral Valve Regurgitation at Rest and During Exercise. Circ Cardiovasc Imaging. 2018 Feb;11(2):e007171. doi: 10.1161/CIRCIMAGING.117.007171.
PubMed 29449412
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Hemodynamic Stress Test in Symptomatic and Asymptomatic Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT02961647
- Acronym / sponsor ID
- HEMI / A5130
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Hemodynamic stress test, Surgical intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Danish Heart Foundation, University of Southern Denmark
- Study start
- Oct 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 11 Nov 2016 (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 preferred treatment of organic mitral regurgitation (MR) is mitral valve repair. Optimally this should be timed so late that it commensurate with the risk of surgery and before irreversibly damage of the heart and pulmonary vessels. The aim is to obtain an understanding of the differences between the symptomatic and asymptomatic patient.
The study will test
A: Symptomatic organic MR is characterized by higher filling pressure, and higher stroke work during physical strain compared with asymptomatic MR.
B: The extent of myocardial fibrosis is associated with filling pressure and cardiac index 1 year after mitral valve repair.
C: Filling pressure can be estimated non-invasively by echocardiography. To test this 40 patients with asymptomatic MR and 40 symptomatic will undergo a stress echocardiography with simultaneous echocardiography and invasive measurement of central hemodynamics. In addition a pulmonary function test and cardiac MRI will be performed.
Detailed description
Background
Degenerative mitral valve disease is the most common cause of organic mitral regurgitation in the Western World. The preferred treatment of organic mitral regurgitation is mitral valve repair. Optimally this should be timed so late that it commensurate with the risk of surgery and before irreversibly damage of the heart and pulmonary vessels. According to the current guidelines mitral valve surgery is indicated in symptomatic patients with severe MR or in presence of known risk factors. The optimal timing of surgery is still controversial in the asymptomatic patients without risk factors.
The overall aim of the present study is to obtain a better understanding of the central hemodynamics at rest and during physical exercise in both symptomatic and asymptomatic patients with organic mitral regurgitation, the relation to neurohormonal activation and myocardial fibrosis, and to identify noninvasive echocardiographic measures suitable for estimation of this.
A epidemiologic sub-study aims to asses whether MR is associated with inherence, as familial clustering of mitral regurgitation earlier has been suggested based only mainly on small observational studies, and case reports.
Methods
The study will test
A: Symptomatic organic MR is characterized by higher filling pressure, and higher stroke work during physical strain compared with asymptomatic MR.
B: The extent of myocardial fibrosis is associated with filling pressure and cardiac index 1 year after mitral valve repair.
C: Filling pressure can be estimated non-invasively by echocardiography.
To test this 40 patients with asymptomatic MR and 40 patients with symptomatic MR will undergo a stress echocardiography with simultaneous echocardiography and invasive measurement of central hemodynamics. In symptomatic patients that undergo surgery, the examination will be repeated 1 year after the surgical mitral valve repair.
In addition pulmonary function test, maximal oxygen consumption test and cardiac MRI will be performed.
The Danish Twin Registry and The Danish National Patient Registry will be used to identify twins with MR. The hypothesis is that the concordance rate is higher in monozygotic twins compared to dizygotic twins.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic patients | – | –Patients with asymptomatic severe mitral valve regurgitation not undergoing surgical repair of the valve. |
| Symptomatic patients | – | Procedure: Mitral valve repairPatients with symptomatic severe mitral valve regurgitation undergoing surgical repair of the valve. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the research project the investigators will examine 80 patients with severe MR, of which 40 do not experience symptoms.
Key inclusion criteria (4 listed)
- Organic mitral valve regurgitation with effective regurgitation orifice (ERO)>0.3 cm2
- Age > 18 years
- Left ventricular ejection fraction (LVEF) > 60% assessed by echocardiography
- Signed informed consent
Key exclusion criteria (6 listed)
- Poor echocardiographic window
- Inability to perform bicycle exercise testing
- Ischemic or functional (secondary) mitral valve regurgitation
- Chronic atrial fibrillation/flutter
- Hemodynamic significant aortic valve disease assessed by echocardiography.
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 |
|---|---|---|
| Mitral valve repairThe intervention is NOT related to the study design. It is a description of patients undergoing surgery vs. not undergoing surgery and this decision is made according to current guidelines (patients are not randomized). | Procedure or surgery | Symptomatic patients |
Primary outcome
Pulmonary artery wedge pressure
Time frame: One year after mitral valve replacement
2 secondary outcomes
Extent of myocardial fibrosis
Time frame: One year after mitral valve replacement
Maximal oxygen consumption
Time frame: One year after mitral valve replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Background: PubMed 22922415Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS); Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012 Oct;33(19):2451-96. doi: 10.1093/eurheartj/ehs109. Epub 2012 Aug 24. No abstract available.
- Background: PubMed 23265342Bonow RO. Chronic mitral regurgitation and aortic regurgitation: have indications for surgery changed? J Am Coll Cardiol. 2013 Feb 19;61(7):693-701. doi: 10.1016/j.jacc.2012.08.1025. Epub 2012 Dec 19.
- Background: PubMed 15745978Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.
- Background: PubMed 23942679Suri RM, Vanoverschelde JL, Grigioni F, Schaff HV, Tribouilloy C, Avierinos JF, Barbieri A, Pasquet A, Huebner M, Rusinaru D, Russo A, Michelena HI, Enriquez-Sarano M. Association between early surgical intervention vs watchful waiting and outcomes for mitral regurgitation due to flail mitral valve leaflets. JAMA. 2013 Aug 14;310(6):609-16. doi: 10.1001/jama.2013.8643.
- Background: PubMed 24396041Naji P, Griffin BP, Asfahan F, Barr T, Rodriguez LL, Grimm R, Agarwal S, Stewart WJ, Mihaljevic T, Gillinov AM, Desai MY. Predictors of long-term outcomes in patients with significant myxomatous mitral regurgitation undergoing exercise echocardiography. Circulation. 2014 Mar 25;129(12):1310-9. doi: 10.1161/CIRCULATIONAHA.113.005287. Epub 2014 Jan 6.
- 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 23563128Ersboll M, Valeur N, Mogensen UM, Andersen MJ, Moller JE, Velazquez EJ, Hassager C, Sogaard P, Kober L. Prediction of all-cause mortality and heart failure admissions from global left ventricular longitudinal strain in patients with acute myocardial infarction and preserved left ventricular ejection fraction. J Am Coll Cardiol. 2013 Jun 11;61(23):2365-73. doi: 10.1016/j.jacc.2013.02.061. Epub 2013 Apr 3.
- Background: PubMed 22848021Witkowski TG, Thomas JD, Debonnaire PJ, Delgado V, Hoke U, Ewe SH, Versteegh MI, Holman ER, Schalij MJ, Bax JJ, Klautz RJ, Marsan NA. Global longitudinal strain predicts left ventricular dysfunction after mitral valve repair. Eur Heart J Cardiovasc Imaging. 2013 Jan;14(1):69-76. doi: 10.1093/ehjci/jes155. Epub 2012 Jul 29.
- Background: PubMed 19269785Dalsgaard M, Kjaergaard J, Pecini R, Iversen KK, Kober L, Moller JE, Grande P, Clemmensen P, Hassager C. Left ventricular filling pressure estimation at rest and during exercise in patients with severe aortic valve stenosis: comparison of echocardiographic and invasive measurements. J Am Soc Echocardiogr. 2009 Apr;22(4):343-9. doi: 10.1016/j.echo.2009.01.007. Epub 2009 Mar 9.
- Background: PubMed 23406672Andersen MJ, Ersboll M, Axelsson A, Gustafsson F, Hassager C, Kober L, Borlaug BA, Boesgaard S, Skovgaard LT, Moller JE. Sildenafil and diastolic dysfunction after acute myocardial infarction in patients with preserved ejection fraction: the Sildenafil and Diastolic Dysfunction After Acute Myocardial Infarction (SIDAMI) trial. Circulation. 2013 Mar 19;127(11):1200-8. doi: 10.1161/CIRCULATIONAHA.112.000056. Epub 2013 Feb 13.
- Derived from this study: PubMed 36356959Andersen MJ, Wolsk E, Bakkestrom R, Christensen N, Carter-Storch R, Omar M, Dahl JS, Frederiksen PH, Borlaug B, Gustafsson F, Hassager C, Moller JE. Pressure-flow responses to exercise in aortic stenosis, mitral regurgitation and diastolic dysfunction. Heart. 2022 Nov 10;108(23):1895-1903. doi: 10.1136/heartjnl-2022-321204.
- Derived from this study: PubMed 30613416Bakkestrom R, Banke A, Pecini R, Irmukhamedov A, Nielsen SK, Andersen MJ, Borlaug BA, Moller JE. Cardiac remodelling and haemodynamic characteristics in primary mitral valve regurgitation. Open Heart. 2018 Dec 16;5(2):e000919. doi: 10.1136/openhrt-2018-000919. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Jacob Møller, Professor contact
Jacob Møller, Professor principal investigator
Department of Cardiology, Odense 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 Mitral Valve Regurgitation, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 6 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 17 May 2017. 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 Denmark. 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 Jacob Møller, Professor (jacob.moeller1@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary artery wedge pressure (time frame: One year after mitral valve replacement). 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 NCT02961647, which also lists 13 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 17 May 2017.