GOREISAN for Heart Failure (GOREISAN-HF) Trial

Launched by TAKESHI MORIMOTO · Dec 30, 2020

Keywords

ClinConnect Summary

The GOREISAN-HF trial is studying a traditional Japanese herbal medicine called Goreisan (TJ-17) to see if it can help patients with heart failure who are experiencing fluid build-up, also known as edema. This trial is looking at how well Goreisan works when added to standard treatments for heart failure compared to standard treatment alone. The goal is to find out if this combination can improve symptoms related to heart failure, such as swelling in the legs or breathing difficulties caused by fluid in the lungs.

To be eligible for this trial, participants need to be at least 20 years old and have been diagnosed with heart failure, showing signs of fluid overload like swelling or breathing issues. They should have certain blood test results indicating heart strain. However, people with recent heart surgeries, certain heart devices, severe kidney issues, or a very short life expectancy are not able to join. Participants can expect regular check-ups and to receive either Goreisan or standard treatment during the study. By joining this trial, they will be contributing to research that could help improve care for others with heart failure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed congestive heart failure (CHF) by Framingham criteria
• • CHF patients with cardiac edema and signs due to cardiac edema (signs of fluid overload: lower limb edema, pulmonary effusion, or pulmonary congestion on chest x-ray)
• • Elevated N-terminal pro brain-type natriuretic peptide (NT-proBNP) ≥300 pg/mL or brain natriuretic peptide (BNP) ≥100 pg/mL at enrollment
• • Patients ≥ 20 years of age, male or female
• • Provision of signed informed consent before any assessment is performed
• Exclusion Criteria:
• • Valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
• • Implantation of a cardiac resynchronization therapy (CRT) within 12 weeks prior to enrollment or intent to implant a CRT device
• • Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
• • End-stage renal failure (estimated glomerular filtration rate \[eGFR\] \<15 mL/min/1.73m2) at enrollment
• • Patients who are expected to have a life expectancy of 6 months or less
• • Acute coronary syndrome at screening
• • Women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization
• • Treatment with herbal medicine at enrollment
• • Confirmed poor tolerability of Goreisan (including cinnamon allergy)
• • Considered not appropriate for the participation of the study