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Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function (REFORM-MR)

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ClinicalTrials.gov Identifier: NCT03470155
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Brief Summary:
Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (LV) dilation and reduced LV ejection fraction (EF). The registry will document the underlying pathology by using transthoracal echo cardiography (TTE) with analysis of common tenting parameters. OP strategies, data and outcomes will be documented, as well as follow-up data for echocardiography, quality of life and MACCE outcomes after 6 months, 1 and 2 years.

Condition or disease Intervention/treatment
Mitral Valve Insufficiency Left Ventricular Systolic Dysfunction Mitral Valve Prolapse Procedure: mitral valve repair

Detailed Description:
Prospective enrolment of all patients with mitral valve insufficiency and restricted movement of leaflets during systole into a multicentric registry. Exact analysis of the underlying pathology using TTE with analysis of tenting parameters. In patients without contraindications, functional preoperative MRT to determine the functional reserve of ventricular function. Documentation of the quality of life of the patients using the SF12 questionnaire before and after intervention. Documentation of follow-up data (SF12, TTE, NT-pro BNP) at 6 months, 1 and 2 years. Development of operative strategies to improve long-term outcomes in patients with severe LV dilation (typically accompanied by function mitral insufficiency type IIIb).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
functional mitral insufficiency op
Patients with functional mitral insufficiency with restricted leaflet movement during systole (type IIIb Carpentier) undergoing operative reconstruction (mitral valve repair)
Procedure: mitral valve repair
operative reconstruction




Primary Outcome Measures :
  1. recurrent mitral valve insufficiency > grade 2 [ Time Frame: 2 years ]
    see above


Secondary Outcome Measures :
  1. MACCE [ Time Frame: 1 year ]
    major adverse cardiovascular and cerebrovascular events

  2. re-intervention at mitral valve [ Time Frame: 2 years ]
    see above

  3. device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure [ Time Frame: 2 years ]
    see above

  4. cardiovascular mortality [ Time Frame: 2 years ]
    see above

  5. re-hospitalisation due to heart failure [ Time Frame: 2 years ]
    see above



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients presenting at participating hospitals with mitral valve dysfunction type III b who give written consent to participate in the registry
Criteria

Inclusion Criteria:

  • functional mitral valve insufficiency with reduced mobility of leaflets during systole (type IIIb) - effective regurgitation orifice area > 20 mm2 / regurgitant volume > 30 ml/beat
  • left ventricular ejection fraction <= 50% and /or left ventricular end-diastolic diameter >= 60 mm
  • tenting of the proximal and / or anterior mitral leaflets

Exclusion Criteria:

  • prolaps of leaflets (type II mitral regurgitation)
  • combination intervention with aortic valve repair or replacement
  • re-operation at mitral valve

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470155


Contacts
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Contact: Christiane Pohlmann, PhD +49(0)4471 85033 ext 28 christiane.pohlmann@ippmed.de
Contact: Kerstin Plate +49(0)447185033 ext 31 kerstin.plate@ippmed.de

Locations
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Germany
Herz- u. Diabeteszentrum NRW Not yet recruiting
Bad Oeynhausen, NRW, Germany, 32545
Contact: Heike Windhagen       hwindhagen@hdz-nrw.de   
Principal Investigator: Gummert, MD         
Herzzentrum Leipzig Not yet recruiting
Leipzig, Sachsen, Germany, 04289
Contact: Anne-Kathrin Funkat, PhD       Anne-Kathrin.Funkat@leipzig-heart.de   
Principal Investigator: Borger, MD         
Charité - Klinik für kardiovaskuläre Chirurgie Not yet recruiting
Berlin, Germany, 10117
Contact: Volkmar Falk, MD       volkmar.falk@charite.de   
Principal Investigator: Volkmar Falk, MD         
Sub-Investigator: Karel van Praet, MD         
Sub-Investigator: Jörg Kempfert, MD         
Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE Recruiting
Hamburg, Germany, 20246
Contact: Evaldas Girdauskas, MD       egirdauskas@web.de   
Principal Investigator: Evaldas Girdauskas, MD         
Sub-Investigator: Eva Harmel, MD         
Sub-Investigator: Jonas Pausch, MD         
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Investigators
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Principal Investigator: Evaldas Girdauskas, MD Universitäres Herzzentrum Hamburg am UKE

Additional Information:

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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT03470155     History of Changes
Other Study ID Numbers: REFORM-MR
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no IPD will be made available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut für Pharmakologie und Präventive Medizin:
annuloplasty mitral valve
reduced LV function
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Mitral Valve Prolapse
Prolapse
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Heart Valve Prolapse