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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048125
Receipt No. 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

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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
Email 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
Email kokada2@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054845

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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