Heart Failure With Nonischemic CardiomyopathyPhase 3NCT04490681
Validation of ERTugliflozin for Inhibiting Cardiac Fibrosis Using Cardiac MRI and Laboratory Parameters in Korean Heart Failure Patients With Nonischemic Cardiomyopathy(VERTICAL)
A Phase 3 study testing Ertugliflozin in people with Heart Failure With Nonischemic Cardiomyopathy, run by Yonsei University at 1 site in South Korea.
Trial summary
Based on recent studies demonstrating SGLT2 inhibitors' favorable effects on cardiovascular outcomes especially for heart failure, the investigators hypothesize that sodium-glucose co-transporter-2 (SGLT2) inhibitor, ertugliflozin, is effective on reducing cardiac fibrosis in patients with nonischemic cardiomyopathy… Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Heart Failure With Nonischemic Cardiomyopathy
- What is being tested?
- Ertugliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2020to Dec 2022
- Phase
- Phase 3
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must agree to the study protocol and provide written informed consent
- Outpatients ≥ 19 years, <75 years of age, male or female
- Non-diabetic or type 2 DM patients with HbA1c 7.0-10.5%
- Patients with nonischemic cardiomyopathy (LVEF ≤40%)
- Exclusion of ischemic origin cardiomyopathy using coronary angiography or CT angiography or SPECT scan (e.g. significant stenosis of proximal LAD or left main \& myocardial infarction)
- Dyspnea of NYHA functional class II or III
- NT-proBNP ≥ 400 pg/ml (≥ 900 pg/ml if atrial fibrillation or atrial flutter)
- Titration of HF medications should be completed and patients must take a stable, optimized dose of a β-blocker and an ACE inhibitor (or ARB or ARNI if indicated) for at least 4 weeks prior to study entry
Who cannot join
- History of hypersensitivity or allergy to the study drug, drugs of similar chemical classes, or SGLT-2 as well as known or suspected contraindications to the study drug
- Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor
- Known history of angioedema
- Current acute decompensated heart failure or dyspnea of NYHA functional class IV
- Medical history of hospitalization within 6 weeks
- Acute coronary syndrome, stroke, major CV surgery, PCI within 3 months
Show all 18Show fewer
- Substantial myocardial ischemia requiring coronary revascularization therapy or a plan of coronary revascularization within 6 months
- A plan of heart transplantation or implantation of cardiac resynchronization therapy
- Symptomatic hypotension and/or a SBP < 95 mmHg at screening
- Estimated GFR < 30 mL/min/1.73m2
- History of ketoacidosis
- Symptomatic peripheral artery disease and history of lower limb amputation
- Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x upper limit of normal (ULN) at screening visit (Visit 0), history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt.
- History of severe pulmonary disease
- Significant mitral \& aortic valve disease (e.g. moderate to severe, severe degree)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a barrier method plus a hormonal method
- Pregnant or nursing (lactating) women
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospiatal
Seoul
Seok-Min Kang, 82-2-2228-8450, smkang@yuhs.ac
About this study
Based on recent studies demonstrating SGLT2 inhibitors' favorable effects on cardiovascular outcomes especially for heart failure, the investigators hypothesize that sodium-glucose co-transporter-2 (SGLT2) inhibitor, ertugliflozin, is effective on reducing cardiac fibrosis in patients with nonischemic cardiomyopathy so the investigators try to examine this hypothesis in a single-center, double-blind, randomized controlled study using cardiac magnetic resonance (CMR).
This study is a prospective, single-center, randomized, double-blind, two arm parallel group, placebo-controlled clinical trial involving patients with nonischemic cardiomyopathy. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 to ertugliflozin or placebo therapy, and cardiovascular functional assessment and clinical event follow-up will be undertaken.
Read the detailed description
Subjects : Patients with non-ischemic cardiomyopathy who need medical treatment Procedures : This is a prospective, randomized trial to compare cardiopulmonary motor tests, cardiac MRI including myocardial fibrosis parameters (ECV, etc.), and incidence of various heart failure-related cardiovascular events during the follow-up period between patients with ertugliflozin drug therapy and placebo drug. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 to ertugliflozin (5mg) or placebo therapy. Randomization will be stratified according to presence of diabetes mellitus, and the upper limit of randomized non-DM patients will be set as 36 patients (70%). The estimated enrollment period is 18 months (n=52) and all patients will be followed for 12 months after randomization. Random assignment is performed at random assignment visit (V1) through eCASE web system and following study procedures will be conducted according to the randomization. CMR, Cardiopulmonary exercise test, serum biomarkers, and clinical endpoints will be measured at 3,6,12 months.
- Being tested
- Ertugliflozin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtugliflozinDrug
Fixed dose Ertugliflozin (5mg)
PlaceboDrug
Placebo group
| Study group | Role | What they receive |
|---|---|---|
| Ertugliflozin | Experimental | Ertugliflozin 5mg Receives: Drug: Ertugliflozin |
| placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
The ECV value change in MRI from baseline to End of trial (48 weeks)
Measured: Baseline
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
The ECV value change in MRI from baseline to End of trial (48 weeks)
Measured: 48 Weeks after drug administration
Secondary outcomes (22)
CMR parameters : ECV (%)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: baseline
CMR parameters : ECV (%)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 12 weeks after drug administration
CMR parameters : ECV (%)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 48 weeks after drug administration
CMR parameters : Native T1 (ms)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: baseline
CMR parameters : Native T1 (ms)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 12 weeks after drug administration
CMR parameters : Native T1 (ms)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 48 weeks after drug administration
CMR parameters : left & right ventricular (LV & RV) mass index (g/m2)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: Baseline
CMR parameters : left & right ventricular (LV & RV) mass index (g/m2)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 12 weeks after drug administration
CMR parameters : left & right ventricular (LV & RV) mass index (g/m2)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 48 weeks after drug administration
CMR parameters : LV & RV ejection fraction (%)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: Baseline
CMR parameters : LV & RV ejection fraction (%)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 12 weeks after drug administration
CMR parameters : LV & RV ejection fraction (%)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 48 weeks after drug administration
CMR parameters : LV & RV end-systolic volume, LV & RV end-diastolic volume (ml)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: Baseline
CMR parameters : LV & RV end-systolic volume, LV & RV end-diastolic volume (ml)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 12 weeks after drug administration
CMR parameters : LV & RV end-systolic volume, LV & RV end-diastolic volume (ml)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 48 weeks after drug administration
CMR parameters : cine-base cardiac strain (%)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: Baseline
CMR parameters : cine-base cardiac strain (%)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 12 weeks after drug administration
CMR parameters : cine-base cardiac strain (%)
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left \& right ventricular (LV \& RV) mass index), ventricular functional markers (LV \& RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV \& RV end-systolic volume, LV \& RV end-diastolic volume). These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
Measured: 48 weeks after drug administration
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
The change in degree of NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7 after drug administration.
Measured: baseline
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
The change in degree of NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7 after drug administration.
Measured: 12 weeks after drug administration
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
The change in degree of NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7 after drug administration.
Measured: 24 weeks after drug administration
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
The change in degree of NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7 after drug administration.
Measured: 48 weeks after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Nonischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490681
- Sponsor's protocol ID
- 4-2020-0484
- Status last verified
- Aug 2020
- First submitted
- 20 Jul 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of ERTugliflozin for Inhibiting Cardiac Fibrosis Using Cardiac MRI and Laboratory Parameters in Korean Heart Failure Patients With Nonischemic Cardiomyopathy(VERTICAL)
- ClinicalTrials.gov ID
- NCT04490681
- Acronym / sponsor ID
- 4-2020-0484
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Jul 2020 (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.
Based on recent studies demonstrating SGLT2 inhibitors' favorable effects on cardiovascular outcomes especially for heart failure, the investigators hypothesize that sodium-glucose co-transporter-2 (SGLT2) inhibitor, ertugliflozin, is effective on reducing cardiac fibrosis in patients with nonischemic cardiomyopathy so the investigators try to examine this hypothesis in a single-center, double-blind, randomized controlled study using cardiac magnetic resonance (CMR).
This study is a prospective, single-center, randomized, double-blind, two arm parallel group, placebo-controlled clinical trial involving patients with nonischemic cardiomyopathy. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 to ertugliflozin or placebo therapy, and cardiovascular functional assessment and clinical event follow-up will be undertaken.
Detailed description
Subjects : Patients with non-ischemic cardiomyopathy who need medical treatment Procedures : This is a prospective, randomized trial to compare cardiopulmonary motor tests, cardiac MRI including myocardial fibrosis parameters (ECV, etc.), and incidence of various heart failure-related cardiovascular events during the follow-up period between patients with ertugliflozin drug therapy and placebo drug. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 to ertugliflozin (5mg) or placebo therapy. Randomization will be stratified according to presence of diabetes mellitus, and the upper limit of randomized non-DM patients will be set as 36 patients (70%). The estimated enrollment period is 18 months (n=52) and all patients will be followed for 12 months after randomization. Random assignment is performed at random assignment visit (V1) through eCASE web system and following study procedures will be conducted according to the randomization. CMR, Cardiopulmonary exercise test, serum biomarkers, and clinical endpoints will be measured at 3,6,12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertugliflozin | Experimental | Drug: ErtugliflozinErtugliflozin 5mg |
| placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must agree to the study protocol and provide written informed consent
- Outpatients ≥ 19 years, <75 years of age, male or female
- Non-diabetic or type 2 DM patients with HbA1c 7.0-10.5%
- Patients with nonischemic cardiomyopathy (LVEF ≤40%)
- Exclusion of ischemic origin cardiomyopathy using coronary angiography or CT angiography or SPECT scan (e.g. significant stenosis of proximal LAD or left main \& myocardial infarction)
Key exclusion criteria (18 listed)
- History of hypersensitivity or allergy to the study drug, drugs of similar chemical classes, or SGLT-2 as well as known or suspected contraindications to the study drug
- Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor
- Known history of angioedema
- Current acute decompensated heart failure or dyspnea of NYHA functional class IV
- Medical history of hospitalization within 6 weeks
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 |
|---|---|---|
| ErtugliflozinFixed dose Ertugliflozin (5mg) | Drug | Ertugliflozin |
| PlaceboPlacebo group | Drug | placebo |
Primary outcome
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
Time frame: Baseline
The ECV value change in MRI from baseline to End of trial (48 weeks)
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
Time frame: 48 Weeks after drug administration
The ECV value change in MRI from baseline to End of trial (48 weeks)
22 secondary outcomes
CMR parameters : ECV (%)
Time frame: baseline
CMR parameters : ECV (%)
Time frame: 12 weeks after drug administration
CMR parameters : ECV (%)
Time frame: 48 weeks after drug administration
CMR parameters : Native T1 (ms)
Time frame: baseline
CMR parameters : Native T1 (ms)
Time frame: 12 weeks after drug administration
CMR parameters : Native T1 (ms)
Time frame: 48 weeks after drug administration
CMR parameters : left & right ventricular (LV & RV) mass index (g/m2)
Time frame: Baseline
CMR parameters : left & right ventricular (LV & RV) mass index (g/m2)
Time frame: 12 weeks after drug administration
CMR parameters : left & right ventricular (LV & RV) mass index (g/m2)
Time frame: 48 weeks after drug administration
CMR parameters : LV & RV ejection fraction (%)
Time frame: Baseline
CMR parameters : LV & RV ejection fraction (%)
Time frame: 12 weeks after drug administration
CMR parameters : LV & RV ejection fraction (%)
Time frame: 48 weeks after drug administration
CMR parameters : LV & RV end-systolic volume, LV & RV end-diastolic volume (ml)
Time frame: Baseline
CMR parameters : LV & RV end-systolic volume, LV & RV end-diastolic volume (ml)
Time frame: 12 weeks after drug administration
CMR parameters : LV & RV end-systolic volume, LV & RV end-diastolic volume (ml)
Time frame: 48 weeks after drug administration
CMR parameters : cine-base cardiac strain (%)
Time frame: Baseline
CMR parameters : cine-base cardiac strain (%)
Time frame: 12 weeks after drug administration
CMR parameters : cine-base cardiac strain (%)
Time frame: 48 weeks after drug administration
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
Time frame: baseline
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
Time frame: 12 weeks after drug administration
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
Time frame: 24 weeks after drug administration
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
Time frame: 48 weeks after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ertugliflozin in people with Heart Failure With Nonischemic Cardiomyopathy, run by Yonsei University 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 8 inclusion and 18 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 7 Aug 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Seok-Min Kang (82-2-2228-8450, smkang@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration (time frame: Baseline). The study lists 2 primary outcomes in all. 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 7 Aug 2020.