Diagnosis and OutcoMes evaluAtIoN of Multicenter Patients With HFpEF Using Multimodality Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

The incidence of Heart failure with preserved ejection fraction (HFpEF) in Heart failure patients increases rapidly. However, the current clinical awareness is insufficient, and the cardiac structural and functional injury are not well understood. It is difficult to recognize the subclinical changes of the cardiac in the early stage with conventional imaging techniques, and it is common to ignore the existence of the clinical alterations. This study aimed to investigate the cardiac features, early diagnosis and risk factors of HFpEF patients, based on the multi-modality (Magnetic resonance imaging- nuclear medicine imaging- echocardiography) imaging and multicenter study, combined with large data and artificial intelligence. This study will provide deep insights into the HFpEF in multicenter population.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

left ventricular ejection fraction (LVEF)≥50%;

N-terminal pro-b type natriuretic peptide (NT-proBNP)>220pg/ml or b type natriuretic peptide (BNP) >80 pg/ml;

symptoms and syndromes of heart failure;

At least one criteria of cardiac structure (left ventricular hypertrophy, or left atrial enlargement) and function abnormalities (based on tissue doppler, color doppler).

Disqualifiers

Special types of cardiomyopathy, including hypertrophic cardiomyopathy, restricted cardiomyopathy, etc.

Infarction, myocardial fibrosis caused by ischemic cardiomyopathy and acute coronary syndrome ;

Severe arrhythmia;

Severe primary cardiac valvular disease;

Trial population

This study is a prospective, multicenter study with HFpEF patients, diagnosed based on 2016 and 2019 European Society of Cardiology (ESC) concensus. The inclusion criteria include left ventricular ejection fraction (LVEF)≥50%;N-terminal pro-b type natriuretic peptide (NT-proBNP)\>220pg/ml or b type natriuretic peptide (BNP) \>80 pg/ml; symptoms and syndromes of heart failure; and at least one criteria of cardiac structure (left ventricular hypertrophy, or left atrial enlargement) and function abnormalities. We exclude patients with special cardiomyopathy, ; Infarction, myocardial fibrosis caused by ischemic cardiomyopathyand acute coronary syndrome; Severe arrhythmia; Severe primary cardiac valvular disease; Restrictive pericardial disease; Refuse to participate in the study.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

All-cause Death

the incidence of all-cause death

Time frame
1-8 year
2

Cardiovascular Death

the incidence of cadridovascular death

Time frame
1-8 year
3

Hospitalization Due to Heart Failure

the incidence of Hospitalization Due to Heart Failure

Time frame
1-8 year

Secondary outcomes

1

Implantable cardioverter-defibrillator Implantation

the incidence of Implantable cardioverter-defibrillator Implantation

Time frame
1-8 year
2

Heart Transplantation

the incidence of Heart Transplantation

Time frame
1-8 year
3

Pacemaker Implantation

the incidence of Pacemaker Implantation

Time frame
1-8 year
4

Atrial fibrillation

the incidence of Atrial fibrillation

Time frame
1-8 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese Academy of Medical Sciences, Fuwai Hospital

Lead sponsor

Peking Union Medical College Hospital

Collaborator

Beijing Anzhen Hospital

Collaborator

China-Japan Friendship Hospital

Collaborator

Guangdong Provincial People's Hospital

Collaborator