Hemodynamic Stress Test in Severe Mitral Regurgitation (HEMI)

NCT02961647 | Unknown DMC

• 1 other identifier: A5130
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mitral Valve Regurgitation

Keywords

Hemodynamic stress test; Surgical intervention

Outcome Measures

Primary Outcomes (1)

• Pulmonary artery wedge pressure

  One year after mitral valve replacement

Secondary Outcomes (2)

• Extent of myocardial fibrosis

  One year after mitral valve replacement

• Maximal oxygen consumption

  One year after mitral valve replacement

Study Arms (2)

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.

Procedure: Mitral valve repair

Interventions

Mitral valve repair PROCEDURE

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).

Symptomatic patients

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the research project the investigators will examine 80 patients with severe MR, of which 40 do not experience symptoms.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Danish Heart Foundation: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Department of Cardiology, Odense University Hospital

Odense, Odense C, 5000, Denmark

RECRUITING

Related Publications (13)

• 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.

  PMID: 22922415 BACKGROUND

• Bonow 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.

  PMID: 23265342 BACKGROUND

• Enriquez-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.

  PMID: 15745978 BACKGROUND

• Suri 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.

  PMID: 23942679 BACKGROUND

• Naji 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.

  PMID: 24396041 BACKGROUND

• 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.

  PMID: 22782970 BACKGROUND

• Ersboll 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.

  PMID: 23563128 BACKGROUND

• Witkowski 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.

  PMID: 22848021 BACKGROUND

• Dalsgaard 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.

  PMID: 19269785 BACKGROUND

• Andersen 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.

  PMID: 23406672 BACKGROUND

• Andersen 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.

  PMID: 36356959 DERIVED

• Bakkestrom 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.

  PMID: 30613416 DERIVED

• Bakkestrom 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.

  PMID: 29449412 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and tissue samples

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Jacob Møller, Professor

  Department of Cardiology, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Møller, Professor

CONTACT

jacob.moeller1@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: November 11, 2016
• Study Start: October 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)