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UMIN-CTR Clinical Trial |
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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 |
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 - |
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Scientific Title:Acronym | DEMAND-HF | |
Region |
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Condition | ||
Condition | patients with heart failure and non-obstructive coronary artery disease (HF-NOCA) | |
Classification by specialty |
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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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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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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 |
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Last modified on |
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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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