Mitral Valve InsufficiencyREFORM-MRNCT03470155
Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function
An observational study of Mitral Valve Insufficiency and Left Ventricular Systolic Dysfunction, run by Institut für Pharmakologie und Präventive Medizin at 6 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency, Left Ventricular Systolic Dysfunction, Mitral Valve Prolapse
- What is being tested?
- mitral valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 6 sitesGermany
- Study dates
- 5 Jun 2018to 31 Jul 2023
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting at participating hospitals with mitral valve dysfunction type III b who give written consent to participate in the registry
Who may be able to join
- 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
Who cannot join
- prolaps of leaflets (type II mitral regurgitation)
- combination intervention with aortic valve repair or replacement
- re-operation at mitral valve
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Zentralklinik Bad Berka
Bad Berka, 99437
Charité - Klinik für kardiovaskuläre Chirurgie
Berlin, 10117
Universitätsklinikum Frankfurt
Frankfurt
Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE
Hamburg, 20246
Herzzentrum Leipzig
Leipzig, Saxony, 04289
Deutsches Herzzentrum München
München, 80636
About this study
Official title: Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion
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.
Read the 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).
- Being tested
- mitral valve repair
- Keywords
- annuloplasty mitral valve, reduced LV function
- Medical subject headings
- Mitral Valve Insufficiency, Ventricular Dysfunction, Left, Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve repairProcedure or surgery
operative reconstruction
| Study group | Role | What they receive |
|---|---|---|
| functional mitral insufficiency op | Patients with functional mitral insufficiency with restricted leaflet movement during systole (type IIIb Carpentier) undergoing operative reconstruction (mitral valve repair) Receives: Procedure: mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent mitral valve insufficiency > grade 2
see above
Measured: 2 years
Secondary outcomes (5)
MACCE
major adverse cardiovascular and cerebrovascular events
Measured: 1 year
re-intervention at mitral valve
see above
Measured: 2 years
device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure
see above
Measured: 2 years
cardiovascular mortality
see above
Measured: 2 years
re-hospitalisation due to heart failure
see above
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start5 Jun 2018
- Primary completion15 Jul 2020
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Evaldas Girdauskas, MD, Principal investigator, Universitäres Herzzentrum Hamburg am UKE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470155
- Sponsor's protocol ID
- REFORM-MR
- Acronym
- REFORM-MR
- Status last verified
- Sep 2023
- First submitted
- 12 Mar 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD will be made available
Publications
Pausch J, Harmel E, Reichenspurner H, Kempfert J, Kuntze T, Owais T, Holubec T, Walther T, Krane M, Vitanova K, Borger MA, Eden M, Hachaturyan V, Bramlage P, Falk V, Girdauskas E. Subannular repair in secondary mitral regurgitation with restricted leaflet motion during systole. Heart. 2023 Aug 24;109(18):1394-1400. doi: 10.1136/heartjnl-2022-322239.
PubMed 37376817Girdauskas E, Pausch J, Reichenspurner H, Kempfert J, Kuntze T, Owais T, Holubec T, Krane M, Vitanova K, Borger M, Eden M, Hachaturyan V, Bramlage P, Falk V. Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry. J Cardiothorac Surg. 2022 Dec 30;17(1):343. doi: 10.1186/s13019-022-02045-9.
PubMed 36581901
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion
- ClinicalTrials.gov ID
- NCT03470155
- Acronym / sponsor ID
- REFORM-MR / REFORM-MR
- Keywords
- annuloplasty mitral valve, reduced LV function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 19 Mar 2018 (actual)
- 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.
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.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| functional mitral insufficiency op | – | Procedure: mitral valve repairPatients with functional mitral insufficiency with restricted leaflet movement during systole (type IIIb Carpentier) undergoing operative reconstruction (mitral valve repair) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting at participating hospitals with mitral valve dysfunction type III b who give written consent to participate in the registry
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- prolaps of leaflets (type II mitral regurgitation)
- combination intervention with aortic valve repair or replacement
- re-operation at mitral valve
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 repairoperative reconstruction | Procedure or surgery | functional mitral insufficiency op |
Primary outcome
recurrent mitral valve insufficiency > grade 2
Time frame: 2 years
see above
5 secondary outcomes
MACCE
Time frame: 1 year
re-intervention at mitral valve
Time frame: 2 years
device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure
Time frame: 2 years
cardiovascular mortality
Time frame: 2 years
re-hospitalisation due to heart failure
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 37376817Pausch J, Harmel E, Reichenspurner H, Kempfert J, Kuntze T, Owais T, Holubec T, Walther T, Krane M, Vitanova K, Borger MA, Eden M, Hachaturyan V, Bramlage P, Falk V, Girdauskas E. Subannular repair in secondary mitral regurgitation with restricted leaflet motion during systole. Heart. 2023 Aug 24;109(18):1394-1400. doi: 10.1136/heartjnl-2022-322239.
- Derived from this study: PubMed 36581901Girdauskas E, Pausch J, Reichenspurner H, Kempfert J, Kuntze T, Owais T, Holubec T, Krane M, Vitanova K, Borger M, Eden M, Hachaturyan V, Bramlage P, Falk V. Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry. J Cardiothorac Surg. 2022 Dec 30;17(1):343. doi: 10.1186/s13019-022-02045-9.
- Individual participant dataSharing planned: No. no IPD will be made available
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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.
Evaldas Girdauskas, MD principal investigator
Universitäres Herzzentrum Hamburg am UKE
6 sites 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 Insufficiency and Left Ventricular Systolic Dysfunction, run by Institut für Pharmakologie und Präventive Medizin at 6 sites in Germany.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent mitral valve insufficiency > grade 2 (time frame: 2 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 NCT03470155, which also lists 2 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 Sep 2023.