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.

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.

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 .

Study Overview

• Status: Completed
• Conditions: Malnutrition; Aged; Heart Failure With Preserved Ejection Fraction; Prognosis

• Study Type: Observational
• Enrollment (Actual): 780

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

elderly HFpEF Ⅱ-Ⅳ patients with coronary heart disease hospitalized in the Department of Geriatrics Medical Department of Beijing Tongren Hospital affiliated to Capital Medical University from January 1, 2017 to December 31, 2019 were selected

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Rheumatic heart disease
2. congenital heart disease
3. acute myocardial infarction
4. hemodialysis or hemofiltration
5. tumour activity, urgent surgery
6. death during hospitalization
7. HF of unknown reasons
8. NYHA classⅠ
9. data deficiency
10. loss of follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
different controlling nutritional status score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
readmission due to heart failure in the first year after hospitalization	up to one year
all-cause mortality in the first year after hospitalization	up to one year

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: BeijingTH20210812chz1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No