Skip to main content
OpenTrials
Completed

NCT Number: NCT05586828

A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.

HF is an advanced or terminal stage of various heart diseases, with high rehospitalization and mortality rates. In HF patients, undernutrition is not uncommon and represents one of the most significant determinants of poor clinical outcomes. Therefore, nutritional management is of paramount importance for patients with HF.The basic method of nutritional management is to effectively identify the nutritional status of patients with heart failure, especially in elderly patients with heart failure who are not easy to find in the early stage. Limited data are available regarding the association between CONUT score and prognosis in elder patients with HFpEF, despite its easy availability in routine blood chemistry. Therefore, we aimed to evaluate the prognostic significance of CONUT score and to compare it with other well-established nutritional indices in HFpEF, a common HF phenotype in the elderly population with coronary artery disease.

This was a single-center retrospective cohort study which were approved by the Clinical Research Ethics Committee of our hospital (TRECKY2021-185). Written informed consent was obtained from all patients.

Participants were accorded with diagnostic criteria of CAD and HFpEF excluding rheumatic heart disease, congenital heart disease, acute myocardial infarction, hemodialysis or hemofiltration, tumour activity, urgent surgery, death during hospitalization, HF of unknown reasons, New York Heart Association(NYHA) class1and data deficiency. Demographic characteristics and medical parameters were collected from the electronic medical record system . All enrolled patients were followed-up in an outpatients setting. The primary endpoint of this study was readmission due to heart failure and all-cause mortality in the first year after hospitalization. To explore the prognostic significance of controlling nutritional status score in elderly with ejection fraction preserved heart failure and compare controlling nutritional status score with other objective nutritional indices.All analyses were performed using Statistical Product Service Solutions(SPSS) version 19.0 .

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patients (≧65years old) were accorded with diagnostic criteria of coronary artery disease, HFpEF and NYHA Ⅱ-Ⅳ
  • Coronary artery disease was defined
  • The diagnosis of HF was made according to the recommendations of the European Society of Cardiology .
  • HFpEF was defined
  • Severity of functional class was based on NYHA scale.

Exclusion criteria

  • Rheumatic heart disease
  • congenital heart disease
  • acute myocardial infarction
  • hemodialysis or hemofiltration
  • tumour activity, urgent surgery
  • death during hospitalization
  • HF of unknown reasons
  • NYHA classⅠ
  • data deficiency
  • loss of follow-up

Treatment and study plan

Primary outcomes

  1. readmission due to heart failure in the first year after hospitalization

    Time frame: up to one year

  2. all-cause mortality in the first year after hospitalization

    Time frame: up to one year

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly With HFpEF and Compare Controlling Nutritional Status Score With Other Objective Nutritional Indices. The Primary Endpoint of This Study Was Readmission Due to HF and All-cause Mortality in 1 Year After Hospitalization.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2022
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.