A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of Controlling Nutritional Status(CONUT) in Elderly Coronary Artery Disease(CAD) Patients With Heart Failure With Preserved Ejection Fraction(HFpEF) and Compare CONUT With Other Objective Nutritional Indices.

Sponsor
Beijing Tongren Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05586828
Collaborator
(none)
780
1
8.9
87.3

Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    780 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT Score in Elderly With HFpEF and Compare Controlling Nutritional Status Score With Other Objective Nutritional Indices. Demographic Characteristics and Medical Parameters of Elderly CAD Patients With HFpEF 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.
    Actual Study Start Date :
    Sep 1, 2021
    Actual Primary Completion Date :
    May 31, 2022
    Actual Study Completion Date :
    May 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    different controlling nutritional status score

    Outcome Measures

    Primary Outcome Measures

    1. readmission due to heart failure in the first year after hospitalization [up to one year]

    2. all-cause mortality in the first year after hospitalization [up to one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 as at least 1 of the following: (1) definite diagnosis by coronary angiography or coronary computed tomography (≥50% stenosis of the internal diameter of at least 1 or more major coronary arteries or branches); (2) previous history of old myocardial infarction, abnormal Q waves in 2 consecutive leads of electrocardiogram, and or previous biochemical markers of myocardial necrosis elevated, and or previous interventional therapy or surgical coronary revascularization. The diagnosis of HF was made according to the recommendations of the European Society of Cardiology . HFpEF was defined as follows: (1) dyspnea, fatigue, or decreased activity tolerance; (2) signs of fluid retention (pulmonary stasis and peripheral edema); (3) echocardiography showing left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography and at least 1 of the following: (1) left ventricular hypertrophy and/or left atrial enlargement; (2) abnormal diastolic function; (4) B-type brain natriuretic peptide (BNP) elevated. 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 and loss of follow-up.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tongren Hospital, Capital Medical University Beijing Beijing China 100730

    Sponsors and Collaborators

    • Beijing Tongren Hospital

    Investigators

    • Study Chair: YING CHEN, Chief Physician, Beijing Tongren Hospital
    • Principal Investigator: HUI ZHENG, M.D., Beijing Tongren Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Tongren Hospital
    ClinicalTrials.gov Identifier:
    NCT05586828
    Other Study ID Numbers:
    • BeijingTH20210812chz1
    First Posted:
    Oct 19, 2022
    Last Update Posted:
    Oct 19, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2022