UMIN-CTR Clinical Trial

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
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Interventions/Control_2
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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
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Research case data
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