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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05278026
Enrollment
2000
Registered
2022-03-14
Start date
2014-01-01
Completion date
2026-01-01
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiovascular diseases; Diastolic dysfunction;Systolic dysfunction; Heart failure; Risk factor

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.

Interventions

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
One minute sit-to-stand test (1-min STST)up to 4 weeksBriefly, 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 yearworsening 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 yearhospitalization due to worsening HF requiring intravenous pharmacological agents (inotrope or vasodilator), mechanical ventilation, mechanical support or ultra- filtration, hemofiltration, or dialysis

Secondary

MeasureTime frameDescription
all-cause and cardiogenic deathsan average of 1 yearall-cause and cardiogenic deaths

Countries

China

Contacts

Primary ContactJunxia Zhang, MD
zhangjunshia@njmu.edu.cn15366155682
Backup ContactChunlei Xia, MD
thunder0703@163.com18796281113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026