Multimodality Imaging in the Screening, Diagnosis and Risk StratifictiON of HFpEF

November 5, 2022 updated by: Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital

Multimodality Imaging (Cardiovascular Magnetic Resonance Imaging, Echocardiography, and Nuclear Medicine Imaging) in the Screening, Diagnosis and Risk Stratification of Heart Failure With Preserved Ejection Fraction (HFpEF).

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-modal (Magnetic resonance imaging- nuclear medicine imaging- echocardiography) imaging, combined with large data and artificial intelligence. This study will provide deep insights into the HFpEF derived from different causes.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Heart Failure with Preserved Ejection Fraction (HFpEF) is a special subtype of Heart Failure (HF), and the incidence of HF cases is rising to 4.5 million every year, according to "Chinese cardiovascular disease report 2018" and "China Heart Failure and diagnostic guidelines 2018". In 2000, the incidence of patients with chronic Heart Failure is as high as 0.9%, and faces significant increase with the increase of age. Moreover, HFpEF patients accounted for over 50% of HF, presenting normal left ventricular ejection fraction (LVEF), and nonspecific HF clinical performance. In addition, as a heterogenous disease, HFpEF is often associated with various comorbidities, including hypertension (~ 75%), diabetes (~ 40%), obesity (> 80%), aging (~ 75 years), renal dysfunction (25-50%), pulmonary hypertension (~ 50%), and other diseases. There is still much confusion about the pathophysiology of the disease, and no effective treatment was confirmed, therefore the diagnosis and treatment of HFpEF has some challenges. With the increase of cardiovascular risk factors such as hypertension (morbidity: 23.2% in 2018), diabetes (morbidity:10.9% in 2018, treatment rate 32.2%) and the aging trend, the morbidity and mortality of HFpEF are still on the rise, posing a threat to the life quality of more and more patients. Early identification and intervention of HFpEF is an important method to reduce mortality and improve prognosis. Yet, many studies have explored the role of different biochemical and inflammatory markers in the diagnosis and prognosis assessment of HFpEF, limited for mixed indicators and low sensitivity.

Cardiac Magnetic Resonance imaging (CMR) is a non-invasive "one-stop" examination, including cardiac structure, function, tissue characteristics, blood perfusion examination. In particular, the emerging T1 mapping and Feature Tracking (FT) techniques enable the early and quantitive identification of cardiac dysfunction prior to abnormal LVEF. It has been found that the Extracellular Volume Fraction (ECV) based on T1 mapping and the myocardial strain parameters based on FT have the ability to diagnose and predict the prognosis of HFpEF patients. Echocardiography takes advantages in early identification of HFpEF patients and reveals the diastolic dysfunction. Nuclear medicine imaging shows priorities in blood perfusion and myocardial viability verification. Magnetic resonance imaging - echocardiography - nuclear medicine multimodal imaging complements and promotes each other, for example, molecular nuclear medicine imaging (recognition of metabolism), echocardiography (primary selection and determination of diastolic dysfunction), as well as the noninvasive high-resolution magnetic resonance and new emerging molecular imaging (identification of macroscopic, microscopic structure and function). The multimodel imaging overcomes the limits of single imaging method, greatly improves the accuracy of early diagnosis ability. However, large studies are based on small samples, and the comprehensive markers derived from large-scale study are lacked. Domestic relevant studies are in the initial stage.

To sum up, this study attempts to achieve early diagnosis and intervention of HFpEF and improve life quality of HFpEF patients through a large-scale study based on multimodel imaging (CMR imaging, echocardiography, nuclear medicine imaging). This study is expected to deepen the understanding of the pathogenesis and pathophysiological characteristic of HFpEF, providing a set of parameters based on multimodel imaging. Hence, assisting in early identification of cardiac structure and function change, early diagnosis of HFpEF and achieving risk stratification. In other way, the marker derived from this study may help target treatment of HFpEF.

Study Type

Observational

Enrollment (Anticipated)

430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study is a prospective 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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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;
  • Restrictive pericardial disease;
  • Refuse to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Death
Time Frame: 1-3 year
Rate or number of All-cause Death
1-3 year
Cardiovascular Death
Time Frame: 1-3 year
Rate or number of Cardiovascular Death
1-3 year
Hospitalization Due to Heart Failure
Time Frame: 1-3 year
Rate or number of Hospitalization Due to Heart Failure
1-3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantable cardioverter-defibrillator Implantation
Time Frame: 1-3 year
Rate or number of Implantable cardioverter-defibrillator Implantation
1-3 year
Heart Transplantation Heart Transplantation
Time Frame: 1-3 year
Rate or number of Heart Transplantation
1-3 year
Pacemaker Implantation
Time Frame: 1-3 year
Rate or number of Pacemaker Implantation
1-3 year
Atrial fibrillation
Time Frame: 1-3 year
Rate or number of Atrial fibrillation
1-3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Principal Investigator: Minjie Lu, PhD, Fuwai Hospital, National Center for Cardiovascular Diseases.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 5, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISSION-HFpEF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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