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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027604
Receipt No. 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 2018/06/13

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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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Age >20 years and <80 years males and females
2)Inadequately controlled type 2 diabetic patients HbA1c >= 6.5% 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
Last name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tsutsui
Organization Kyushu University Hospital
Division name Cardiology
Zip code
Address Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL +81-92-642-5360
Email rika-628@med.kyushu-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Noriyuki Sonoda
Organization Kyushu University Hospital
Division name Endocrinology and Metabolism
Zip code
Address Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL +81-92-642-5284
Homepage URL
Email rika-628@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

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
Address
Tel
Email

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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 08 Day
Last follow-up date
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
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031635

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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