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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278026
• Other study ID #: ChiHFpEF-Cohort
• Status: Recruiting
• Start date: January 1, 2014
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Junxia Zhang, MD
• Phone: 15366155682
• Email: zhangjunshia[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• guideline recommended routine treatment

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One minute sit-to-stand test (1-min STST)	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.	up to 4 weeks
Primary	Worsening of heart failure (HF)	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	an average of 1 year
Primary	Hospitalization due to worsening of heart failure (HF)	hospitalization due to worsening HF requiring intravenous pharmacological agents (inotrope or vasodilator), mechanical ventilation, mechanical support or ultra- filtration, hemofiltration, or dialysis	an average of 1 year
Secondary	all-cause and cardiogenic deaths	all-cause and cardiogenic deaths	an average of 1 year

External Links

•   Lp(a) [Lipoprotein(a)]-Related Risk of Heart Failure Is Evident in Whites but Not in Other Racial/Ethnic Groups
•   Race/Ethnic Differences in Outcomes Among Hospitalized Medicare Patients With Heart Failure and Preserved Ejection Fraction
•   Racial Differences in Characteristics and Outcomes of Patients With Heart Failure and Preserved Ejection Fraction in the Treatment of Preserved Cardiac Function Heart Failure Trial