chronic heart failure heart failure, cardiomyopathy
Conditions
Interventions
Sponsors
Tsutsui Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients enrolled in the HUCV002-01-02 study who were assigned to the standard treatment arm 2) Patients diagnosed with chronic heart failure 3) 20 years old or older, 90 years or younger at the time of informed consent 4) LVEF=100 pg/mL, OR, NT-proBNP>=400 pg/mL 7) Refractory to standard medical therapy on JCS/JHFS 2021 Guideline Focused Update on Diagnosis and Treatment of Acute and Chronic Heart Failure with no clinical improvement 8) Patients who has ability to understand and sign the informed consent
Exclusion criteria
Exclusion criteria: 1)Chronic heart failure dues to operable valvular disease, congenital cardiac disease or coronary arterial disease 2)Awaiting cardiac transplant 3)Acute myocardial infarction within 28 days prior to the enrollment 4)Cerebrovascular disease within 28 days before the enrollment 5)Coronary artery revascularization (CABG, PCI) was performed or planned within 3 months before getting consent or during the clinical study 6)New treatments for cardiac failure was started within 3 months before the enrollment 7)Patients with malignancy or history of malignant diseases within 1 year prior to the study (Except for those who had cured carcinoma in situ or intramucosal carcinoma) 8)Uncontrolled hypertension (systemic BP>160mmHg or diastolic BP>100mmHg) 9)Symptomatic hypotension 10)Autoimmune disease 11)Any of the following within 7 days before the registration a)Hepatic dysfunction: AST or ALT > ULN x3 b)Renal dysfunction: eGFR 2.0 m^2 (Du Bois) 19)Functional gait disorder 20)Pregnant, lactating, or possible pregnant female. Female who wants to become pregnant or male who wants his partner to become pregnant. Those who refuses contraception during the study. 21)Those who participated in other clinical studies within 28 days prior to getting the informed consent. Those who plans to participate in other clinical studies during this study. 22)Patients who are taking amiodarone or have taken it in the past. 23)SpO2 (room air) < 93% within 28 days before the enrollment. 24)Patients with severe lung disease or a history of non-infectious interstitial lung disease requiring steroid therapy. 25)Patients whom the PI or investigators decided as inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in left ventricular ejection fraction from baseline to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of cardiac function Evaluation of exercise tolerability Clinical events due to the progression of heart failure adverse events | — |
Contacts
Public ContactTomomi Ide
Kyushu University Hospital
Outcome results
None listed