UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055635 |
|---|---|
| Receipt number | R000063567 |
| Scientific Title | Effect of exercise training on heart failure with preserved ejection fraction complicated with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2025/07/30 07:41:11 |
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Basic information
Public title
Effect of exercise training on heart failure with preserved ejection fraction complicated with type 2 diabetes mellitus
Acronym
Effect of exercise training on heart failure with preserved ejection fraction complicated with type 2 diabetes mellitus
Scientific Title
Effect of exercise training on heart failure with preserved ejection fraction complicated with type 2 diabetes mellitus
Scientific Title:Acronym
Effect of exercise training on heart failure with preserved ejection fraction complicated with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Heart failure with preserved ejection fraction, type 2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Geriatrics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the effects of exercise-training on exercise capacity and prognosis in heart failure with preserved ejection fraction differ in complicated with or without type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Changes in peak oxygen uptake, and 6-minute walk distance from baseline following exercise training intervention
Key secondary outcomes
Occurrence of a composite endpoint of heart failure-related readmission or all-cause mortality after the end of the 5-month exercise-training intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Moderate-intensity exercise training
Interventions/Control_2
Moderate-intensity exercise training
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
New York Heart Association (NYHA) functional classification 2 to 3
Heart failure with preserved ejection fraction
Clinical symptoms of heart failure
Left ventricular ejection fraction>50%
Left ventricular diastolic dysfunction as defined by the American Society of Echocardiography/European Association of Cardiovascular Imaging
HFA-PEFF score >5 points
Type 2 diabetes mellitus
Fasting plasma glucose level was >126 mg/dL
2 h value for the 75 g oral glucose tolerance test was >200 mg/dL
Causal plasma glucose level was > 200 mg/dL
Hemoglobin A1c level > 6.5%
Key exclusion criteria
1.Exacerbation of subjective symptoms of heart failure(dyspnea, fatigue, etc.) within the past week
2.Unstable angina or low threshold (induced by slow walking on level ground 2METs) myocardial ischemia
3.Severe valvular disease for which surgery is indicated, especially aortic stenosis
4.Severe left ventricular outflow tract stenosis (obstructive hypertrophic cardiomyopathy)
5.Untreated exercise-induced severe arrhythmia (ventricular fibrillation, persistent ventricular tachycardia)
6.Active myocarditis
7.Acute systemic disease or fever
8.Other diseases for which exercise therapy is contraindicated (moderate or higher aortic aneurysm, severe hypertension, thrombophlebitis, embolism within 2 weeks, serious other organ damage, etc.)
9.Patients with congenital cardiovascular disease
10.Renal failure with estimated glomerular filtration rate <30
11.Persons who have been diagnosed with psychiatric disorders
12.Malignant tumor
13.Persons who fall under the NYHA classification <New York Heart Association functional classification> grade I (patients with heart disease with no restrictions on physical activity) and grade IV (patients with heart disease who have symptoms in any physical activity)
14.65 years old or younger, 80 years old or older
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Sugita |
Organization
National University Corporation Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
305-0821
Address
4-12-7, Kasuga, Tsukuba-shi, Ibaraki, 305-8521, Japan
TEL
029-858-9539
y.sugita@cc.k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | Yousuke |
| Middle name | |
| Last name | Sugita |
Organization
National University Corporation Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
305-0821
Address
4-12-7, Kasuga, Tsukuba-shi, Ibaraki, 305-8521, Japan
TEL
029-858-9539
Homepage URL
y.sugita@cc.k.tsukuba-tech.ac.jp
Sponsor or person
Institute
National University Corporation Tsukuba University of Technology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National University Corporation Tsukuba University of Technology
Address
4-3-15, Amakubo, Tsukuba-shi, Ibaraki, 305-0005, Japan
Tel
029-858-9539
kenkyo@ad.tsukuba-tech.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
| 2024 | Year | 09 | Month | 26 | 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
152
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063567
