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.

Malnutrition Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586828
• Other study ID #: BeijingTH20210812chz1
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2022
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Elderly patients (?65years old) were accorded with diagnostic criteria of coronary artery disease, HFpEF and NYHA ?-?

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 class?

9. data deficiency

10. loss of follow-up

Related Conditions & MeSH terms

• Aged
• Heart Failure With Preserved Ejection Fraction
• Malnutrition
• Prognosis

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	readmission due to heart failure in the first year after hospitalization		up to one year
Primary	all-cause mortality in the first year after hospitalization		up to one year