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APPETIZE-HF trial

Phase 4
Recruiting
Conditions
Chronic heart failure with loss of appetite
Registration Number
JPRN-jRCTs051220162
Lead Sponsor
Seo Masahiro
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
80
Inclusion 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

Exclusion 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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