APPETIZE-HF trial

JRCT ID: jRCTs051220162

Registered date:30/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic heart failure with loss of appetite
• Date of first enrollment: 23/06/2023
• Target sample size: 80
• Study type: Interventional

Intervention(s)

The patients were randomly assigned to group A or group B.
group A:Conventional treatment.
group B :Oral administration of TSUMURA Rikkunshito 7.5 g/day in 2 or 3 divided doses before or between meals adding conventional treatment.

Outcome(s)

• Primary Outcome: To evaluate the amount of change SMI by the BIA method using Seca mBCA 515 Medical Body Composition Analyzer.

Secondary Outcome

(1) Body composition(SMI,FFMI,BMI,FMI,phase angle,ECW/TBW)
(2) Questionnaire survey(QOL(KCCQ,EQ-5D-5L), Appetite score(CNAQ-J), PGA)
(3) Blood test (RBC, WBC (Basophils, eosinophils, neutrophils, lymphocytes, monocytes), Hb, Ht, Plt, Alb, Prealbumin, T-Chol, CHE, BNP, NT-proBNP, Na, K, Cl, AST, ALT, AI-P, gamma-GTP, T-Bil, Cr, BUN, Uric acid, CRP, High-sensitivity CRP)
(4) Outpatient blood test (appetite hormone: acylated ghrelin, unacylated ghrelin, inflammatory marker: IL-6, TNF-alpha, IL-1beta, growth hormone: Growth Hormone, IGF-1, IGFBP-3, others: blood Sirtuin-1)
(5) Transthoracic echocardiography (heart rate, presence of atrial fibrillation, LVDd/Ds, left ventricular end-diastolic volume /end systolic volume, IVS/PW, FS, LVEF, Left atrial volume, E wave, A wave, E/A, DcT(not measured in case of atrial fibrillation), e' wave, a' wave, E/e', LVOT-VTI, RVD, TRPG, IVC maximum diameter / minimum diameter, TAPSE, FAC, S' wave, aortic insufficiency(severity), mitral insufficiency(severity), tricuspid insufficiency(severity), myocardial strain analysis, LVOT diameter, CO, CI)
(6) Grip power
(7) Prognosis information(total death, cardiovascular death, non-cardiovascular death, heart failure admission)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients diagnosed with chronic heart failure:<1>Patients with a history of hospitalization for heart failure or <2>Patients with risk factors for heart failure, symptoms of heart failure such as shortness of breath, or abnormal ECG, and NT-proBNP>=125pg/ml or BNP>=35pg/ml which was measured at the timing within 3 months of informed consent, and some abnormal findings on echocardiography.
(2) Patients with an appetite loss:CNAQ(Council on Nutrition appetite questionnaire)-J of 28 or less
(3) Patients who are age 20 years and over on the day informed consent obtained and are adequate oral intake
(4) Patients who can provide written consent

Exclude criteria

(1) Patients using the implantable medical device
(2) Patients with BMI > 23.5 kg/m2
(3) Patients who have used Rikkunshito and/or other kampo medicines within 4 weeks before enrollment
(4) Patients hospitalized for acute heart failure within 3 months before study consent
(5) Patients scheduled for catheter intervention or ablation/cardiac surgery within the study period
(6) Patients unable to stand (If patients can hold on, patients can register.)
(7) Patients on dialysis
(8) Patients with malignant disease with a prognosis considered to be within 6 months
(9) Patients who received gastrectomy
(10) Patients with a history of allergy to kampo medicines
(11) Patients who are pregnant or potentially pregnant, patients breast-feeding, or patients aiming to become pregnant during the clinical trial
(12) Patients who are ineligible in the opinion of the investigator

Related Information

• Primary Sponsor: Seo Masahiro
• Source(s) of Monetary Support: TSUMURA&amp;CO.