UMIN-CTR Clinical Trial

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
Email	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
Email	yooouyou@gmail.com

Sponsor
Institute	Mitsui Memorial Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054689