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Cohort Study of Heart Failure With Preserved Ejection Fraction in Chinese Han

Recruiting
Conditions
Heart Failure
Interventions
Other: guideline recommended routine treatment
Registration Number
NCT05278026
Lead Sponsor
Nanjing First Hospital, Nanjing Medical University
Brief Summary

To analyze factors contributing to the development and prognosis of heart failure with preserved ejection fraction.

Detailed Description

Based on previous studies on development of heart failure with preserved ejection fraction (HFpEF), racial/ethnical background should be underscored when evaluating risk f actors for HFpEF incidence. As the ageing population increases sharply in China, HFpEF represents the dominant phenotype of all patients diagnosed with heart failure. In this cohort study, the investigators evaluated exposures or risk factors for HFpEF in Chinese Han patients with cardiovascular diseases (CVD). Our study may provide preventive and therapeutic targets for HFpEF in Chinese CVD patients.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
2000
Inclusion Criteria
  • Patients with CVD, defined as at least one diagnosis of coronary heart disease, hypertension, type 2 diabetes or cardiomyopathy. The definition of coronary heart disease was stenosis of the main coronary arteries ≥ 50% using percutaneous coronary angiography or coronary computed tomography angiography findings. The definition of hypertension was systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg or pharmacological treatment. The definition of type 2 diabetes was fasting blood glucose ≥ 7.0 mmol/L, random blood glucose ≥ 11.1 mmol/L and HbA1c > 6.5% or the or the use of hypoglycaemic medications. Cardiomyopathy was defined as the presence of cardiac insufficiency in patients with dilated cardiomyopathy suggested by percutaneous coronary angiography or coronary CT angiography use of hypoglycaemic medications.
Exclusion Criteria
  • primary diagnoses of atherosclerosis (stenosis of the main coronary arteries < 50%), congenital heart diseases, arrhythmia, lung diseases, aortic dissection, peripheral vascular diseases, pericardial diseases, myocarditis, hypertrophic cardiomyopathy, heart valvular diseases, cardiophobia, costal chondritis, shock, thyroid diseases, infection or concomitant liver or renal dysfunction.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
HFrEFguideline recommended routine treatmentheart failure with reduced ejection fraction
nonfailing controlguideline recommended routine treatmentpatients without heart failure
HFpEFguideline recommended routine treatmentheart failure with preserved ejection fraction
Primary Outcome Measures
NameTimeMethod
One minute sit-to-stand test (1-min STST)up to 4 weeks

Briefly, each subject was instructed in sitting position to extend both knees at the same time, starting from a 90° knee flexion position to a 180° extension, which works the thigh muscles, and especially the quadriceps.

Worsening of heart failure (HF)an average of 1 year

worsening of symptoms defined as either failure to improve (persistent symptoms and signs of acute HF during treatment) or recurrent symptoms and signs of acute HF, pulmonary edema, or cardiogenic shock after initial stabilization , either of which requiring increased use of diuretics (as outpatient or inpatient), addition of a new intravenous therapy (diuretics, inotrope, or vasodilator) or mechanical support

Hospitalization due to worsening of heart failure (HF)an average of 1 year

hospitalization due to worsening HF requiring intravenous pharmacological agents (inotrope or vasodilator), mechanical ventilation, mechanical support or ultra- filtration, hemofiltration, or dialysis

Secondary Outcome Measures
NameTimeMethod
all-cause and cardiogenic deathsan average of 1 year

all-cause and cardiogenic deaths

Trial Locations

Locations (1)

Nanjing First Hospital

🇨🇳

Nanjing, Jiangsu, China

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