Tricuspid RegurgitationReduction-TRNCT05686616
SGLT2 Inhibitor for Severe Tricuspid Regurgitation
A study testing Dapagliflozin Propanediol Hydrate 12.3 mg in people with Tricuspid Regurgitation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated severe TR. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Dapagliflozin Propanediol Hydrate 12.3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Apr 2022to 3 Mar 2025
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant over 20 years of age who understands the research protocol and has written informed consent
- Participant with severe tricuspid valve regurgitation
- Vena contracta width > 0.7cm or effective regurgitant orifice (ERO)≥40mm2 for more than 1 month despite medical treatment
- Participant with left ventricular ejection fraction ≥ 40%
- Participant with NYHA class II or more
Who cannot join
- Patient with severe mitral valve or aortic valve disease
- Left ventricular ejection fraction less than 40%*
- Patient with severe pulmonary hypertension (TR Vmax > 4m/s)
- Patient with acute heart failure or dyspnea of NYHA functional class IV or higher
- Symptomatic hypotension or systolic blood pressure < 90 mmHg at screening
- Patient with severe lung disease (asthma, obstructive pulmonary disease, acute pulmonary embolism)
Show all 14Show fewer
- Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysis
- Patient with Type 1 diabetes
- If a woman of childbearing potential has not used double contraception
- Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging
- Blood AST or ALT value is more than twice the upper limit of normal or symptoms and signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of symptomatic ascites)
- Life expectancy is less than one year
- Patient who already take SGLT-2 inhibitor
- A history of hypersensitivity or allergy to SGLT2 inhibitor
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Eun Kyoung Kim, MD PhD, 82234103419, ekbobi.kim@samsung.com
Ji Hoon Kim, MD, 82234103419, jh9933.kim@samsung.com
About this study
Official title: Multicenter, Randomized, Controlled Trial to Assess the Efficacy of Sodium Glucose Cotransporter-2 Inhibitor add-on Treatment in Patients With Severe Tricuspid Regurgitation
The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated severe TR.
Read the detailed description
After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to SGLT2i add-on group or conventional treatment group.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Dapagliflozin Propanediol Hydrate 12.3 mg
- Keywords
- tricuspid regurgitation, SGLT2 inhibitor
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin Propanediol Hydrate 12.3 mgDrug
Also called Forxiga Tablet 10mg
Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 inhibitor group | Active comparator | Participants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks. Receives: Drug: Dapagliflozin Propanediol Hydrate 12.3 mg |
| Conventional treatment group | No intervention | Participants will continue the existing medications for severe TR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
RVESV index at 12 months - RVESV index at baseline
Measured: Baseline and month 12
Secondary outcomes (5)
Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi)
RVEDV index at 12 months - RVEDV index at baseline
Measured: Baseline and month 12
Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF)
RVEF at 12 months - RVEF at baseline
Measured: Baseline and month 12
Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (∆VCW)
TR VCW at 12 months - TR VCW at baseline
Measured: Baseline and month 12
Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up
Tricuspid annulus diameter at 12 months - Tricuspid annulus diameter at baseline
Measured: Baseline and month 12
Difference of TR volume by CMR from baseline to 12 months follow-up
TR volume at 12 months - TR volume at baseline
Measured: Baseline and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start13 Apr 2022
- Primary completion13 Apr 2024 (estimated)
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Ji Park, Samsung Medical Center
- Investigators
- Sung Ji Park, MD, PhD, Principal investigator, Heart Vascular Stroke Institute, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686616
- Sponsor's protocol ID
- Reduction TR
- Acronym
- Reduction-TR
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Controlled Trial to Assess the Efficacy of Sodium Glucose Cotransporter-2 Inhibitor add-on Treatment in Patients With Severe Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT05686616
- Acronym / sponsor ID
- Reduction-TR / Reduction TR
- Conditions
- Tricuspid Regurgitation
- Keywords
- tricuspid regurgitation, SGLT2 inhibitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 13 Apr 2024 (estimated)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 17 Jan 2023 (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.
The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated severe TR.
Detailed description
After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to SGLT2i add-on group or conventional treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2 inhibitor group | Active comparator | Drug: Dapagliflozin Propanediol Hydrate 12.3 mgParticipants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks. |
| Conventional treatment group | No intervention | –Participants will continue the existing medications for severe TR. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant over 20 years of age who understands the research protocol and has written informed consent
- Participant with severe tricuspid valve regurgitation
Key exclusion criteria (14 listed)
- Patient with severe mitral valve or aortic valve disease
- Left ventricular ejection fraction less than 40%*
- Patient with severe pulmonary hypertension (TR Vmax > 4m/s)
- Patient with acute heart failure or dyspnea of NYHA functional class IV or higher
- Symptomatic hypotension or systolic blood pressure < 90 mmHg at screening
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 |
|---|---|---|
| Dapagliflozin Propanediol Hydrate 12.3 mgAlso: Forxiga Tablet 10mgForxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group. | Drug | SGLT2 inhibitor group |
Primary outcome
Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
Time frame: Baseline and month 12
RVESV index at 12 months - RVESV index at baseline
5 secondary outcomes
Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi)
Time frame: Baseline and month 12
Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF)
Time frame: Baseline and month 12
Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (∆VCW)
Time frame: Baseline and month 12
Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up
Time frame: Baseline and month 12
Difference of TR volume by CMR from baseline to 12 months follow-up
Time frame: Baseline and month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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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.
Sung Ji Park, MD, PhD principal investigator
Heart Vascular Stroke Institute, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin Propanediol Hydrate 12.3 mg in people with Tricuspid Regurgitation, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 14 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 17 Jan 2023. 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 South Korea. 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 Eun Kyoung Kim, MD. PhD (82-2-3410-3419, ekbobi.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi) (time frame: Baseline and month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2023.