Phase II clinical study of TY-0201 in patients with chronic heart failure

Phase 2

• Conditions: Chronic heart failure

• Registration Number: jRCT2080222593
• Lead Sponsor: TOA EIYO LTD.

Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with chronic heart failure due to ischemic heart disease, dilated cardiomyopathy or dilated phase of hypertrophic cardiomyopathy.
2. New York Heart Association (NYHA) class I, II or III.
3. Patients diagnosed with chronic heart failure and confirmed =< 40 % of left ventricular ejection fraction (LVEF) before the day of informed consent.
4. Patients whose medication for chronic heart failure has been optimized without any change of the dosage and administration.
5. Outpatients

Exclusion Criteria

1. Patients without the implantation of pacemaker and whose pulse rate are < 50 beats/min.
2. Systolic blood pressure < 90 mmHg.
3. Patients with complication of hypertrophic obstructive cardiomyopathy, cardiogenic shock, severe valve stenosis or valve regurgitation, severe or multiple arrhythmia, or secondary cardiomyopathy with rapid deterioration.
4. Patients with poor skin condition at the patch application site or history of dermatitis due to a topical agent, etc.

Study & Design

• Study Type: Interventional
• Study Design: Multicenter, Open-label study

Primary Outcome Measures

Name	Time	Method
-		The change in LVEF