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Functional Tricuspid RegurgitationNCT02721524

Ring Versus Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases

A study testing Tricuspid Annuloplasty in people with Functional Tricuspid Regurgitation, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to compare whether De Vega's Suture annuloplasty is equally effective in reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring annuloplasty in Rheumatic Heart Disease patients with concurrent Mitral valve replacement. Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Functional Tricuspid Regurgitation
What is being tested?
Tricuspid Annuloplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteNepal
Study dates
Nov 2015to Sep 2016
Phase
Interventional
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 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The participants will be all patients between 15 to 75 years of age group diagnosed as a case of Rheumatic Mitral Valve disease with moderate to severe functional Tricuspid regurgitation.

Who cannot join

  • Patient with organic Tricuspid Valve (TV) lesion diagnosed in Echocardiography
  • Patient with FTR requiring Mitral Valve repair
  • Patient with FTR requiring concomitant aortic valve replacement
  • Patient with FTR secondary to pathology other than Mitral valve disease

Trial locations and contacts

1 site in 1 country.

Binita Tamrakar, RN contact

+97714371322 ext. 576

ircsgnhc@gmail.com

Nepal1 site, 1 recruiting

  • Shahid Gangalal National Heart Centre

    Kathmandu, Bagmati, 44606

    Binita Tamrakar, RN, +97714371322 ext. 576, ircsgnhc@gmail.com

    Recruiting

Other trials in Nepal

About this study

Official title: Comparison Between Outcomes Of Ring And Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases

This study aims to compare whether De Vega's Suture annuloplasty is equally effective in reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring annuloplasty in Rheumatic Heart Disease patients with concurrent Mitral valve replacement.

Read the detailed description

Functional Tricuspid regurgitation (FTR) occurs due to annular dilatation in association with left sided valve disease and is more commonly seen than primary pathology in patients with Rheumatic mitral valve disease. FTR occurs due to increased right ventricle after load that leads to either dilatation or geometric deformation of Tricuspid annulus. If left untreated, FTR may worsen and increase morbidity and mortality.

Being tested
Tricuspid Annuloplasty
Keywords
Ring Annuloplasty, Suture Annuloplasty, Functional Tricuspid Regurgitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tricuspid AnnuloplastyProcedure or surgery

    Patients will undergo repair of tricuspid regurgitation

Study groups in NCT02721524
Study groupRoleWhat they receive
Group R (ring)Active comparatorPatients in Group R will undergo tricuspid ring annuloplasty
Receives: Procedure: Tricuspid Annuloplasty
Group S (suture)Active comparatorPatients in Group S will undergo De Vega's suture annuloplasty
Receives: Procedure: Tricuspid Annuloplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in severity of FTR

    Definitions:

    1. Improvement in FTR: refers to Mild or No TR
    2. Tricuspid regurgitation is graded as mild, moderate, and severe based on regurgitant jet area i. <5cm2 = Mild ii. 6-10cm2 = Moderate iii. >10cm2 = Severe

    Measured: within 3 months

Secondary outcomes (1)

  1. Mortality

    Mortality: Mortality within hospital stay or 3 months postoperative.

    Measured: up to 3 months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionSep 2016 (estimated)
  4. Study completionSep 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02721524
Sponsor's protocol ID
TRICUSPID STUDY-RCT
Status last verified
Mar 2016
First submitted
16 Mar 2016
Last updated
29 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Tang GH, David TE, Singh SK, Maganti MD, Armstrong S, Borger MA. Tricuspid valve repair with an annuloplasty ring results in improved long-term outcomes. Circulation. 2006 Jul 4;114(1 Suppl):I577-81. doi: 10.1161/CIRCULATIONAHA.105.001263.

    PubMed 16820641

  • Guenther T, Mazzitelli D, Noebauer C, Hettich I, Tassani-Prell P, Voss B, Lange R. Tricuspid valve repair: is ring annuloplasty superior? Eur J Cardiothorac Surg. 2013 Jan;43(1):58-65; discussion 65. doi: 10.1093/ejcts/ezs266. Epub 2012 May 24.

    PubMed 22627660

  • Sarralde JA, Bernal JM, Llorca J, Ponton A, Diez-Solorzano L, Gimenez-Rico JR, Revuelta JM. Repair of rheumatic tricuspid valve disease: predictors of very long-term mortality and reoperation. Ann Thorac Surg. 2010 Aug;90(2):503-8. doi: 10.1016/j.athoracsur.2010.03.105.

    PubMed 20667339

  • Rivera R, Duran E, Ajuria M. Carpentier's flexible ring versus De Vega's annuloplasty. A prospective randomized study. J Thorac Cardiovasc Surg. 1985 Feb;89(2):196-203.

    PubMed 3881631

  • Badano LP, Muraru D, Enriquez-Sarano M. Assessment of functional tricuspid regurgitation. Eur Heart J. 2013 Jul;34(25):1875-85. doi: 10.1093/eurheartj/ehs474. Epub 2013 Jan 9.

    PubMed 23303656

  • Rogers JH, Bolling SF. The tricuspid valve: current perspective and evolving management of tricuspid regurgitation. Circulation. 2009 May 26;119(20):2718-25. doi: 10.1161/CIRCULATIONAHA.108.842773.

    PubMed 19470900

  • McCarthy PM, Bhudia SK, Rajeswaran J, Hoercher KJ, Lytle BW, Cosgrove DM, Blackstone EH. Tricuspid valve repair: durability and risk factors for failure. J Thorac Cardiovasc Surg. 2004 Mar;127(3):674-85. doi: 10.1016/j.jtcvs.2003.11.019.

    PubMed 15001895

  • Navia JL, Nowicki ER, Blackstone EH, Brozzi NA, Nento DE, Atik FA, Rajeswaran J, Gillinov AM, Svensson LG, Lytle BW. Surgical management of secondary tricuspid valve regurgitation: annulus, commissure, or leaflet procedure? J Thorac Cardiovasc Surg. 2010 Jun;139(6):1473-1482.e5. doi: 10.1016/j.jtcvs.2010.02.046. Epub 2010 Apr 14.

    PubMed 20394950

Questions about this trial

What is this clinical trial studying?

A study testing Tricuspid Annuloplasty in people with Functional Tricuspid Regurgitation, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.

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 1 inclusion and 4 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 29 Mar 2016. 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 Nepal. 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 Binita Tamrakar, RN (+97714371322 ext. 576, ircsgnhc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in severity of FTR (time frame: within 3 months). 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 NCT02721524, which also lists 8 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 29 Mar 2016.

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