Mitral Regurgitation Clinical Trial
— NOSTRUMOfficial title:
Annuloplasty for the Treatment of Not-Severe Tricuspid Regurgitation in Patients Undergoing Surgery for Mitral Valve Disease: a Prospective, Spontaneous, Multicentre, Randomized Study
NCT number | NCT02996552 |
Other study ID # | 072/11 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 8, 2011 |
Est. completion date | December 2030 |
The surgical treatment of less than severe (≤2+/4+) functional tricuspid regurgitation (TR)
in patient undergoing mitral valve surgery, is still controversial: some observational
studies have suggested that performing tricuspid annuloplasty in patients undergoing mitral
valve surgery with a dilated tricuspid annulus, and TR≤2+ may provide a clinical benefit,
while in other observational studies such benefit has not been documented.
The ESC Guidelines assign the class IIa recommendation for surgical treatment in patients
with tricuspid regurgitation ≤2+ and a dilated annulus, if surgery is concomitant to the
repair or replacement of the mitral valve. However the level of evidence C (expert opinion)
confirms the absence of clear scientific evidence to support this recommendation.
It is therefore very important to carry out randomized trials designed to really prove the
supposed efficacy of prophylactic tricuspid annuloplasty, especially in patients with
degenerative etiology where the data are particularly controversial.
The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in
the early stage of TR. The investigators enrolled patients with TR≤2+ and annular dilation
undergoing mitral valve repair.
Primary end-point will be the freedom from recurrence of TR≥3+ and from progression of 2
degrees of TR compared to pre-operative, at discharge and 12 months after surgery, assessment
by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of
combined treatment (M & T Repair Group) compared to single treatment (Mitral-Only Group) at 5
and 10 years after surgery.
This will be an experimental superiority, prospective, spontaneous, multicenter, randomized
trial.
Patients will be randomly assigned to two parallel arms with an allocation ratio 1:1
stratified by center, to receive mitral repair only (Mitral-Only group) or both mitral and
tricuspid repair (M & T Repair group).
Status | Recruiting |
Enrollment | 142 |
Est. completion date | December 2030 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - age > 18 years; - ability to provide informed consent; - patients scheduled for mitral valve regurgitation - TR = 2+ with annular dilation - Tricuspid diastolic diameter = 40 mm or 21 mm/m2 Exclusion Criteria: - patient's refusal - non-elective cardiac surgery; - organic disease of tricuspid valve - TR=3 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Ospedale San Raffaele | Milan | |
Italy | Istituto Clinico Humanitas | Rozzano | Milano |
Poland | Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Ospedale San Raffaele | Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, Istituto Clinico Humanitas |
Italy, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The 1-year freedom from recurrence of TR=3+ and from progression by 2 degrees compared to pre-operative. | 1 year | ||
Secondary | The 5-year freedom from recurrence of TR >= 3+ and from progression by 2 degrees compared to pre-operative, in the combined treatment group (M & T Repair Group) and in the single treatment group ( Mitral-Only Group) | 5 years | ||
Secondary | The 10-year freedom from recurrence of TR >= 3+ and from progression by 2 degrees compared to pre-operative, in the combined treatment group (M & T Repair Group) and in the single treatment group ( Mitral-Only Group) | 10 years |
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