UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027604 |
|---|---|
| Receipt number | R000031635 |
| Scientific Title | A clinical study for cardioprotective effect of empagliflozin in T2DM patients with heart failure and exploring associated factors |
| Date of disclosure of the study information | 2017/06/02 |
| Last modified on | 2025/12/10 14:04:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical study for cardioprotective effect of empagliflozin in T2DM patients with heart failure and exploring associated factors
Acronym
Effect of empagliflozin for HFpEF with Type2 DM (EMPOWERMENT)
Scientific Title
A clinical study for cardioprotective effect of empagliflozin in T2DM patients with heart failure and exploring associated factors
Scientific Title:Acronym
Effect of empagliflozin for HFpEF with Type2 DM (EMPOWERMENT)
Region
| Japan |
Condition
Condition
Type2 DM
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study will verify effects and mechanism of SGLT2-inhibition on the CV system for chronic heart failure patients of diabetes with HFpEF (heart failure with preserved ejection fraction).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aim of this study is to investigate whether empagliflozin could improve heart failure (HF) of T2DM patients with HFpEF (heart failure with preserved ejection fraction). Severity and improvement of HF is evaluated by oxygen uptake efficiency (Peak VO2) obtained during the submaximal portion of cardiopulmonary exercise testing (CPET), which is one of the most reliable and accurate parameter of HF severity.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with empagliflozin 10mg (usual dose in Japan) once a daily for 12 weeks.
Interventions/Control_2
Treatment with sitagliptin 50mg (usual dose in Japan) once a daily for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Age >20 years and <85 years males and females
2)Inadequately controlled type 2 diabetic patients HbA1c >= 6.0% and HbA1c < 10%
3)Type 2 diabetic patients with LV ejection fraction > 50% and a symptom of heart failure (NYHA II or III)
4)BNP >= 35pg/dL
5)Patients from whom a written informed consent are obtained
Key exclusion criteria
1)Other than T2DM such as T1DM and secondary DM.
2)Patients with severe infection, perioperative patients, patients with severe trauma.
3)Patients receiving SGLT2 inhibitor and/or incretin-related drugs within 2 months before ingestion of study drug.
4)Patients with idiopathic cardiomyopathy, Fabry disease, Amyloidosis cardiomyopathy.
5)Patients with renal insufficiency (eGFR< 45 ml/min/1.73m2).
6)Patients with severe respiratory disease, severe musculoskeletal conditions and unable to exercise challenge test for any other diseases, and severe anemia.
7)Any uncontrolled endocrine disorder except type 2 diabetes.
8)Acute coronary syndrome, stroke, or transient ischemic attack within 3 months of IC.
9)Patient who is scheduled to undergo surgery within 3 months before IC or plan to operate within 3 months after IC.
10)Patients who have a heart pacemaker, who have an aneurysm clip in their brain more than 20 years ago, or have a body implantation device (Implanted cardioverter-defibrillator , Cochlear, otologic, or other ear implant, or Neurostimulation system).
11)Patients with severe claustrophobia.
12)Patients who are pregnant or breast-feeding.
13)Patients lower than BMI 20.
14)Patients in hyperglycemic crisis or accompanied with marked symptom of hyperglycemia and /or DKA.
15)Patients considered inappropriate to participate in the study by the principal and/or sub- investigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University Hospital
Division name
Cardiology
Zip code
812-8582
Address
Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
+81-92-642-5360
sagara.rikako.316@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Rikako |
| Middle name | |
| Last name | Sagara |
Organization
Kyushu University Hospital
Division name
Endocrinology and Metabolism
Zip code
812-8582
Address
Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
+81-92-642-5284
Homepage URL
sagara.rikako.316@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Eli Lilly and Company
IRB Contact (For public release)
Organization
Kyushu University Hospital
Address
Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan, 812-8582
Tel
+81-92-642-5284
byskenkyu@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
40 patients (empagliflozin 22, sitagliptin 18), PPS 33 (19/14). No significant difference in peak VO2 change at 12 weeks (+0.87 vs +0.10 mL/kg/min, p=0.35). LVEF: +7.10% vs +0.16% (p=0.03); NYHA improved (p=0.027); IVC: -1.55 vs +0.86 mm (p=0.005); leg strength: -3.69 vs +7.25 kg (p=0.06).
Results date posted
| 2025 | Year | 12 | Month | 10 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Results have not yet been published in a peer-reviewed journal because the manuscript is under review.
Date of the first journal publication of results
Baseline Characteristics
Japanese patients with T2DM and HFpEF were enrolled (age 20-85 years, HbA1c 6.0-10%, BNP >35 pg/mL, LVEF >=50%, NYHA class II-III). Forty participants were randomized to empagliflozin (n=22) or sitagliptin (n=18). Baseline assessments included CPET, echocardiography, cardiac MRI, body composition, grip strength, and lower extremity muscle strength.
Participant flow
Forty participants were randomized to empagliflozin (n=22) or sitagliptin (n=18). Treated participants were 21 in the empagliflozin group and 17 in the sitagliptin group. Seven participants were excluded from per-protocol analyses due to no treatment, poor adherence, or changes in cardiac rhythm. The per-protocol set included 33 participants (empagliflozin n=19; sitagliptin n=14).
Adverse events
Adverse events occurred in 4/21 treated participants (19%) in the empagliflozin group and in 0/17 treated participants (0%) in the sitagliptin group. Events in the empagliflozin group were recurrence of pancreatic cancer (considered unlikely related to the study drug; treatment discontinued to prioritize cancer management), pollakiuria, thirst, and decreased blood pressure (one case each).
Outcome measures
Primary outcome: change in peak VO2 measured by cardiopulmonary exercise testing (CPET) from baseline to 12 weeks.
Secondary outcomes: changes from baseline to 12 weeks in anaerobic threshold (AT), BNP concentrations, NYHA class, left and right ventricular ejection fraction (LVEF/RVEF) assessed by cardiac MRI, skeletal muscle mass, grip strength, and lower extremity muscle strength (maximal isometric knee extension strength).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031635
