Clinical trial NCT05278026: Cohort Study of Heart Failure With Preserved Ejection Fraction in Chinese Han
Official title: Cohort Study of Heart Failure With Preserved Ejection Fraction in Chinese Han
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: Cardiovascular diseases; Diastolic dysfunction;Systolic dysfunction; Heart failure; Risk factor
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were enrolled from Nanjing First Hospital, a public tertiary care university hospital in Nanjing, China.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: One minute sit-to-stand test (1-min STST)
timeFrame: up to 4 weeks
measure: Worsening of heart failure (HF)
timeFrame: an average of 1 year
measure: Hospitalization due to worsening of heart failure (HF)
timeFrame: an average of 1 year
Secondary outcomes:
measure: all-cause and cardiogenic deaths
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References: