UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048125 |
|---|---|
| Receipt number | R000054845 |
| Scientific Title | DEtecting MicrovAscular dysfunction with Non-obstructive coronary artery Disease in Heart Failure - Multi-center, prospective, observational study - |
| Date of disclosure of the study information | 2022/06/21 |
| Last modified on | 2022/06/21 18:23:35 |
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Basic information
Public title
DEtecting MicrovAscular dysfunction with Non-obstructive coronary artery Disease in Heart Failure
Acronym
DEMAND-HF
Scientific Title
DEtecting MicrovAscular dysfunction with Non-obstructive coronary artery Disease in Heart Failure
- Multi-center, prospective, observational study -
Scientific Title:Acronym
DEMAND-HF
Region
| Japan |
Condition
Condition
patients with heart failure and non-obstructive coronary artery disease (HF-NOCA)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the prevalence and degrees of coronary microvascular dysfunction (CMD) and to investigate their associations with clinical outcomes as well as clinical and pathological characteristics in subjects with HF-NOCA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is a composite of worsening heart failure or cardiovascular death and the associations of the presence and degrees of CMD with the primary endpoint will be investigated. An episode of worsening heart failure is either an unplanned hospitalization or more than or equal to 2 points of the following criteria: 1) worsening symptom of heart failure, 2) congestion on chest X-ray, and 3) significant increases in BNP or NT-pro BNP.
Key secondary outcomes
Key secondary endpoints are the following variables, and their associations with the presence and degrees of CMD will be assessed.
1) a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal cerebral vascular disease
2) a composite of all-cause death or hospitalization for heart failure
3) hospitalization for heart failure, including repeat admission
4) newly developed arrhythmia such as atrial fibrillation
5) The primary endpoint will be also evaluated in the subgroup analyses stratified by LVEF (i.e., heart failure with preserved or reduced LVEF)
Additional secondary endpoints are as follows, and compared between the groups stratified by the presence and degrees of CMD.
1) Time courses of parameters of echocardiography (LVEF, LVDd, LVDs, LAD, E/A, E/e, etc.)
2) Hemodynamic indexes (cardiac index, pulmonary artery wedge pressure, pulmonary artery pressure, right ventricular pressure, right atrial pressure, end-diastolic left ventricular pressure, Tau, etc.)
3) Pathological indexes from the right ventricular endomyocardial biopsy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient with greater than or equal to 20 years of age.
2) Patient who has been informed of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical sites.
3) Patient who underwent coronary angiography and physiological assessments during the index HF admission.
4) Patient who agrees to undergo all protocol-requiring follow-up examinations and requirements at the investigational site.
5) Patient with any left ventricular ejection fraction (LVEF) level is eligible.
Key exclusion criteria
1) Patient with heart failure due to ischemic heart disease defined as prior myocardial infarction and/or significant obstructive coronary artery at coronary artery trees defined as stenosis greater than or equal to 75% on visual evaluation and/or fractional flow reserve (FFR) less than or equal to 0.8.
2) Patient with severe valvular heart disease.
3) Patient with congenital heart disease.
4) Patient with chronic kidney disease (eGFR less than 30 ml/min/1.73m2) or on chronic hemodialysis (and/or peritoneal dialysis).
5) Patient with heart failure due to hyperthyroidism.
6) Patient with persistent tachycardia (heart rate greater than or equal to 100bpm) at the evaluation of coronary physiology.
7) Patient with heart failure due to severe anemia less than 8.0 g/dl or requiring blood transfusion.
8) Patient who cannot regularly visit a hospital or patient with a life expectancy less than or equal to 24 months due to terminally non-cardiac illness.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hibi |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku, Yokohama
TEL
045-261-5656
hibikiyo@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kozo |
| Middle name | |
| Last name | Okada |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku, Yokohama
TEL
045-261-5656
Homepage URL
kokada2@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa PTCA Research Association
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
Yokohama City University
Address
3-9, Fukuura, kanazawa-ku, Yokohama, Japan
Tel
045-370-7627
rinri@yokohama-cu.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
| 2022 | Year | 06 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center, prospective, observational study
Coronary angiographic and physiological data will be analyzed at the Cardiovascular Core Analysis Laboratory, Stanford University School of Medicine in the USA.
Right or left ventricular endomyocardial biopsy will be analyzed at National Cerebral and Cardiovascular Center in Japan.
Management information
Registered date
| 2022 | Year | 06 | Month | 21 | Day |
Last modified on
| 2022 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054845
