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

NCT05278026 | Unknown

• 1 other identifier: ChiHFpEF-Cohort
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• all-cause and cardiogenic deaths

  an average of 1 year

Study Arms (3)

HFrEF

heart failure with reduced ejection fraction

Other: guideline recommended routine treatment

HFpEF

heart failure with preserved ejection fraction

Other: guideline recommended routine treatment

nonfailing control

patients without heart failure

Other: guideline recommended routine treatment

Interventions

guideline recommended routine treatment OTHER

HFpEF; HFrEF; nonfailing control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects were enrolled from Nanjing First Hospital, a public tertiary care university hospital in Nanjing, China.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Central Study Contacts

Junxia Zhang, MD

CONTACT

15366155682; zhangjunshia@njmu.edu.cn

Chunlei Xia, MD

CONTACT

18796281113; thunder0703@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: March 14, 2022
• Study Start: January 1, 2014
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)