Evidence map›Paper›PMID 38628048›Full record

ArticleESC heart failure2024

Oral nutritional supplements in older outpatients with heart failure: rationale and design of the ALIMENT-HF trial.

Yudai Fujimoto, Taishi Dotare, Emi Maekawa, Kentaro Kamiya, Takeshi Kitai, Koichiro Kuwahara, Teruyasu Sugano, Masaaki Konishi, Tomohito Ohtani, Yoko Sakamoto and 5 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in ESC heart failure, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 1 country.

Yudai FujimotoDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Taishi DotareDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Emi MaekawaDepartment of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan.
Kentaro KamiyaDepartment of Rehabilitation, School of Allied Health Sciences, Kitasato University, Sagamihara, Japan.
Takeshi KitaiDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Centre, Suita, Japan.
Koichiro KuwaharaDepartment of Cardiovascular Medicine, Shinshu University School of Medicine, Matsumoto, Japan.
Teruyasu SuganoDepartment of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Masaaki KonishiDepartment of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Tomohito OhtaniDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
Yoko SakamotoDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
Kentaro JujoDepartment of Cardiology, Saitama Medical University, Kawagoe, Japan.
Chiharu NodaChiharu Heart Clinic, Sagamihara, Japan.
Junya AkoDepartment of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan.
Naotake YanagisawaMedical Technology Innovation Center, Clinical Research and Trial Center, Juntendo University, Tokyo, Japan.
Yuya MatsueDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0003-2456-8525
Juntendo University · JPKitasato University · JPThe University of Osaka · JPYokohama City University · JPNational Cerebral and Cardiovascular Center · JPNational Sagamihara Hospital · JPSaitama Medical University · JPShinshu University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe ALIMENT-HF trial aims to determine whether high-calorie and high-protein oral nutritional supplements (ONS) are safe and beneficial for older adult outpatients with heart failure (HF). METHODS AND

resultsThis multicentre, single-arm, interventional pilot trial is designed to evaluate the tolerance, efficacy, and safety of ONS in older adult outpatients with chronic HF, malnutrition, and anorexia. In total, 80 outpatients with HF regardless of their left ventricular ejection fraction will be treated with ONS, including high-energy (900 kcal/day) and high protein (36 g/day) supplementation, at eight sites in Japan. Inclusion criteria are as follows: age, ≥65 years; outpatients receiving maximally tolerated guideline-directed medical therapy for HF and without change in their diuretic dosage during the last 3 months; outpatients at risk of malnutrition, defined as a Malnutrition Universal Screening Tool score ≥1 point, and anorexia, defined using a Simplified Nutritional Appetite Questionnaire for the Japanese Elderly (SNAQ-JE) score of ≤14 points. Nutritional intervention will continue for up to 120 days, with an observational period lasting for a further 60 days. The primary outcome is a change in body weight between baseline and day 120.

conclusionsThe ALIMENT-HF trial will evaluate the tolerance, efficacy, and safety of high-calorie and high-protein-rich ONS in older outpatients with HF co-morbid with malnutrition and anorexia and will provide insightful information for future randomized controlled trials.

Indexed as

Dietary SupplementsHeart FailureOutpatientsAdministration, OralAgedClinical Trials as TopicFemaleFollow-Up StudiesHumansJapanMaleMalnutritionMulticenter Studies as TopicNutritional StatusPilot ProjectsStroke VolumeAnorexiaHeart failureMalnutritionOlder patientONS

Identifiers

PMID38628048
PMCPMC11287343
OpenAlexW4394873005

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.