A Multicenter Exprolatory Single-arm Interventional Trial to Evaluate the Tolerability and Efficacy of Oral Nutritional Supplement in Older Patients with Heart Failure Complicated with Malnutrition and Anorexia: ALIMENT-HF

JRCT ID: jRCTs031230449

Registered date:16/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 19/02/2024
• Target sample size: 80
• Study type: Interventional
• Intervention(s): For 120 days, the target dose of INOLAS is 562.5 ml (900 kcal) per day, taken orally in several divided doses, in addition to the normal diet.

Outcome(s)

Primary Outcome

Amount of change in body weight
valuate the amount of change from the time of enrollment to 120 days later

Secondary Outcome

Evaluate the amount/percentage change from time of enrollment to 120 days after

-Limb skeletal muscle mass (measured by BIA method)
-Comparison of 6-minute walk distance before and after
-Short Physical Performance Battery (SPPB) score
-Grip strength (measured with a grip strength meter)
-Hematological/biochemical/urinalysis values
-Body measurements (upper arm circumference, lower leg circumference, triceps subcutaneous fat thickness, brachialis muscle circumference)
-Protein intake using the protein intake estimation equation(Clin Exp Nephrol. 2016;20:258-264.) of Kanno et al.
-Medication compliance of INOLAS
-QOLscore (KCCQ-TSS)

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Age >=65 years at the time of obtaining consent (regardless of gender)
(2) Patients diagnosed with heart failure who meet any of the following criteria
1.acute noncompensated heart failure with a history of hospitalization
(ECG at admission : sinus rhythm:NT-pro BNP>200pg/ml or BNP>100pg/ml)
Atrial Fibrillation:NT-Pro BNP>600pg/ml or BNP>120pg/ml)
2.decompensated heart failure with no history of hospitalization : i) ii) Both are satisfied
i) in addition to previous heart failure symptoms, meet the following criteria on blood draw
-sinus rhythm : NT-pro BNP>300 pg/ml or BNP>150 pg/ml
-Atrial Fibrillation : NT-Pro BNP>900 pg/ml or BNP>180 pg/ml
ii) at least one episode of heart failure and has received diuretics for it
*Definition of Heart Failure Symptoms : a) b) Both are satisfied
a) Dyspnea induced at rest or with mild exertion
b) Two or more of the following are met: jugular venous distention, pulmonary rales, leg edema,
and pulmonary congestion on plain photomicrograph
*Diuretics: loop diuretics, thiazide diuretics, thiazide-like diuretics or Tolvaptan
(3) Patients treated for heart failure according to guidelines whenever possible
(4) loop diuretic dosage has not changed for at least 90 days prior to starting INOLAS
(5) low nutrition as defined by MUST >=1 point
(6) orally consume a normal diet and have anorexia as defined by SNAQ-JE <=14 points
(7) Regular outpatient visits expected for at least 180 days
(8) Patients who have been fully informed about their participation in this study,
and who have given their free and voluntary written consent based on their full understanding of the study

Exclude criteria

(1) Patients with complications such as hyperthyroidism, hypothyroidism, Crohn's disease, ulcerative colitis and other diseases affecting nutritional and metabolic pathology
(2) Patients with at least one hepatic or renal disorder that meets the following criteria
-AST (GOT) or ALT (GPT) exceeding 2.5 times the upper limit of the facility standard
-Cr > 2.0 mg/dL
(3) Poorly controlled diabetic patients (HbA1c>=8.4%)
(4) Patients with a history of gastrointestinal resection (colorectal polypectomy and appendicitis surgery are acceptable)
(5) Patients with contraindications listed in the INOLAS's drug information
(6) Patients who have taken an enteral nutrition product approved for medical use or a commercially available concentrated liquid diet at least once within one month of the date of consent
(7) Other patients deemed inappropriate by the physician

Related Information

• Primary Sponsor: Matsue Yuya
• Source(s) of Monetary Support: EN Otsuka Pharmaceutical Co., Ltd.