UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048016 |
|---|---|
| Receipt number | R000054689 |
| Scientific Title | Efficacy of empagliflozin on diastolic dysfunction during exercise stress echocardiography in patients with heart failure with preserved ejection fraction Prospective open-label randomized parallel-group study |
| Date of disclosure of the study information | 2022/06/09 |
| Last modified on | 2022/08/08 14:06:33 |
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Basic information
Public title
Efficacy of empagliflozin on diastolic dysfunction during exercise stress echocardiography in patients with heart failure with preserved ejection fraction
Prospective open-label randomized parallel-group study
Acronym
SUMMIT study
Scientific Title
Efficacy of empagliflozin on diastolic dysfunction during exercise stress echocardiography in patients with heart failure with preserved ejection fraction
Prospective open-label randomized parallel-group study
Scientific Title:Acronym
SUMMIT study
Region
| Japan |
Condition
Condition
Heart failure with preserved ejection fraciton
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether oral empagliflozin 10 mg in addition to standard therapy improves diastolic dysfunction on exercise stress echocardiography in patients with heart failure with preserved left ventricular ejection fraction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in peak E/e' from baseline to 90 days in exercise stress echocardiography
Key secondary outcomes
<Secondary outcomes>
Changes in peak TR velocity, peak E wave, peak e', and peak DCT in exercise stress echocardiography from baseline to 90 days
<Exploratory Endpoint>
Changes from baseline to 90 days in resting echocardiography: GLS, atrial strain, LVEF, LVDVI, LVSVI, LVDd, LVDs, LVMI, E/e', TR velocity, E wave, A wave, e', DCT, LA volume, LAD, TAPSE, RVFAC, TRPG, pericardial fat
Changes from baseline to 90 days in exercise stress echocardiography: B-line, peak Watt and peak METs
Changes in blood tests from baseline to 90 days: NT-proBNP, eGFR, Na, K, Alb, Hgb, Hct, PV, total cholesterol, lymphocytes, Glu, HbA1c
Changes in urinalysis from baseline to 90 days: Na, K, Alb, NAG, osmolality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Empagliflozin 10 mg once daily for 90 days
Adjustment of antihypertensive drugs and diuretics 90 days
Interventions/Control_2
Adjustment of antihypertensive drugs and diuretics 90 days
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
1) Age 20 years and older to less than 90 years old
2) Dyspnea on exertion
3) EF 50% on resting echocardiography
4) HFA-PEFF score >= 2 points calculated based on the result of echocardiography at rest
5) peak E/e' (average) >= 15 on exercise stress echocardiography and HFA-PEFF score >= 5 points
6) Patients who have given written informed consent
Key exclusion criteria
1) eGFR< 20 mL/min/1.72m2
2) Already taking SGLT2 inhibitor
3) Type 1 DM
4) A clear cause of dyspnea on exertion other than heart failure
5) At risk of ketoacidosis or hyperosmotic hyperglycemia
6) Pregnant or lactating women
7) Severe regurgitation or moderate or severe stenotic valvular disease. Valve replacement surgery.
8) Regional wall motion disorder of the left ventricle that may cause inaccurate measurement of E/e'.
9) Cardiovascular surgery, implantable cardioverter-defibrillator, implantable cardioverter-defibrillator with biventricular pacing, implantable ventricular assist device, etc. within 30 days
10) Acute coronary syndrome, pulmonary thromboembolism, cerebral infarction, or transient ischemic attack within 90 days
11) Ventricular tachycardia with syncope noted within 90 days.
12) Heart transplantation, implantable artificial heart implantation, or palliative therapy.
13) Patients with severe valvular heart disease who are expected to undergo open heart surgery or catheterization therapy in the near future.
14) Amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry's disease, or muscular dystrophy. Takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complicated congenital heart disease, and heart failure due to pericardial contraction
15) Postpartum cardiomyopathy within 6 months
16) Active myocarditis
17) Uncontrolled thyroid disease
18) Symptomatic bradycardia or complete atrioventricular block. Permanent pacemaker implantation.
19) Severe hepatic dysfunction or cirrhosis with portal hypertension
20) Alcohol abuse
21) Active or suspected malignant tumors diagnosed within 2 years.
22) Comorbidities other than heart failure for which prognosis is not expected to be more than 1 year.
23) Participating in a clinical trial with another drug within 30 days
24) Other conditions that may interfere with patient safety or protocol compliance
25) Other patients deemed unsuitable by the investigator.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Horiuchi |
Organization
Mitsui Memorial Hospital
Division name
Division of cardiology
Zip code
101-8643
Address
Izumicho-1, Kanda, Chiyoda-ku, Tokyo
TEL
03-3862-9111
yooouyou@gmail.com
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Horiuchi |
Organization
Mitsui Memorial Hospital
Division name
Division of cardiology
Zip code
101-8643
Address
Izumicho-1, Kanda, Chiyoda-ku, Tokyo
TEL
03-3862-9111
Homepage URL
yooouyou@gmail.com
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mitsui Memorial Hospital
Address
Izumicho-1, Kanda, Chiyoda-ku, Tokyo
Tel
03-3862-9111
c-uno@mitsuihosp.or.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
| 2022 | Year | 06 | Month | 09 | 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
| 2022 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 09 | Day |
Last modified on
| 2022 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054689
