Exploratory study of hochuekkito for exercise capacity of patients with heart failure (HET Study)

JRCT ID: jRCTs031230348

Registered date:19/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure patients scheduled to undergo home-based cardiac rehabilitation
• Date of first enrollment: 21/12/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): hochuekkito administered three times daily (2.5 g each, 7.5 g / day)

Outcome(s)

• Primary Outcome: Walk distance of six-minute walk test

Secondary Outcome

1) Muscle strength (Grip strength)
2) Motivation (Apathy scale score)
3) Fatigue, Shortness of breath, Appetite (VAS)
4) QOL (EQ-5D-5L Japanese version)
5) Physical activity (Number of steps)
6) Nutrition (Body weight, Prealbumin)
7) Heart function (BNP)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients performing home-based cardiac rehabilitation
2) Patients with stage C heart failure staging in ACCF/AHA guidelines
3) Patients who can walk independently
4) Patients aged 18 or older
5) Male or female
6) Patients who can take study drug orally
7) Patients who are able to provide written consent

Exclude criteria

1) Patients with biventricular pacemaker placement or after implantation of a ventricular assist device
2) Patients with a history of heart transplantation
3) Patients at risk of severe arrhythmia, including ventricular tachycardia
4) Patients with serum potassium levels less than 3.0 mEq/L within 12 weeks before enrollment
5) Patients with severe liver or renal disorder
6) Patients with malignant tumors
7) Patients with mental illness who cannot respond to questionnaire surveys
8) Patients who have a history of allergies or side effects (such as pseudo aldosteronism) in kampo (herbal medicine)
9) Patients with a history of serious drug allergy such as anaphylactic shock or a history of serious side effects
10) Patients taking prohibited drugs or study drugs within 2 weeks before consent
11) Pregnant or potentially pregnant patients
12) Lactating patient
13) Patients with symptoms such as eczema and dermatitis
14) Other patients who are judged inappropriate for participation in this study by the investigator or co-investigator

Related Information

• Primary Sponsor: Amiya Eisuke
• Source(s) of Monetary Support: Tsumura & Co.