patients with heart failure and non-obstructive coronary artery disease (HF-NOCA)
Conditions
Interventions
None listed
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKozo Okada
Yokohama City University Medical Center Division of Cardiology
Outcome results
None listed