NCT04602338

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Nov 2020Jun 2028

First Submitted

Initial submission to the registry

October 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

6.6 years

First QC Date

October 20, 2020

Last Update Submit

April 14, 2022

Conditions

Heart Failure, DiastolicMulticenter Study

Keywords

heart failure with preserved ejection fractioncardiovascular magnetic resonance imagingechocardiographynuclear medicine imagingearly diagnosisprognosis

Outcome Measures

Primary Outcomes (3)

  • All-cause Death

    the incidence of all-cause death

    1-8 year

  • Cardiovascular Death

    the incidence of cadridovascular death

    1-8 year

  • Hospitalization Due to Heart Failure

    the incidence of Hospitalization Due to Heart Failure

    1-8 year

Secondary Outcomes (4)

  • Implantable cardioverter-defibrillator Implantation

    1-8 year

  • Heart Transplantation

    1-8 year

  • Pacemaker Implantation

    1-8 year

  • Atrial fibrillation

    1-8 year

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (13)

  • Tsao CW, Lyass A, Enserro D, Larson MG, Ho JE, Kizer JR, Gottdiener JS, Psaty BM, Vasan RS. Temporal Trends in the Incidence of and Mortality Associated With Heart Failure With Preserved and Reduced Ejection Fraction. JACC Heart Fail. 2018 Aug;6(8):678-685. doi: 10.1016/j.jchf.2018.03.006. Epub 2018 Jul 11.

    PMID: 30007560RESULT

  • Shah SJ, Kitzman DW, Borlaug BA, van Heerebeek L, Zile MR, Kass DA, Paulus WJ. Phenotype-Specific Treatment of Heart Failure With Preserved Ejection Fraction: A Multiorgan Roadmap. Circulation. 2016 Jul 5;134(1):73-90. doi: 10.1161/CIRCULATIONAHA.116.021884.

    PMID: 27358439RESULT

  • Altara R, Giordano M, Norden ES, Cataliotti A, Kurdi M, Bajestani SN, Booz GW. Targeting Obesity and Diabetes to Treat Heart Failure with Preserved Ejection Fraction. Front Endocrinol (Lausanne). 2017 Jul 17;8:160. doi: 10.3389/fendo.2017.00160. eCollection 2017.

    PMID: 28769873RESULT

  • De Keulenaer GW, Brutsaert DL. Systolic and diastolic heart failure: different phenotypes of the same disease? Eur J Heart Fail. 2007 Feb;9(2):136-43. doi: 10.1016/j.ejheart.2006.05.014. Epub 2006 Aug 1.

    PMID: 16884955RESULT

  • Campbell RT, McMurray JJ. Comorbidities and differential diagnosis in heart failure with preserved ejection fraction. Heart Fail Clin. 2014 Jul;10(3):481-501. doi: 10.1016/j.hfc.2014.04.009.

    PMID: 24975911RESULT

  • Guazzi M. Pulmonary hypertension in heart failure preserved ejection fraction: prevalence, pathophysiology, and clinical perspectives. Circ Heart Fail. 2014 Mar 1;7(2):367-77. doi: 10.1161/CIRCHEARTFAILURE.113.000823. No abstract available.

    PMID: 24643889RESULT

  • Simmonds SJ, Cuijpers I, Heymans S, Jones EAV. Cellular and Molecular Differences between HFpEF and HFrEF: A Step Ahead in an Improved Pathological Understanding. Cells. 2020 Jan 18;9(1):242. doi: 10.3390/cells9010242.

    PMID: 31963679RESULT

  • Loai S, Cheng HM. Heart failure with preserved ejection fraction: the missing pieces in diagnostic imaging. Heart Fail Rev. 2020 Mar;25(2):305-319. doi: 10.1007/s10741-019-09836-8.

    PMID: 31364028RESULT

  • Marwick TH, Shah SJ, Thomas JD. Myocardial Strain in the Assessment of Patients With Heart Failure: A Review. JAMA Cardiol. 2019 Mar 1;4(3):287-294. doi: 10.1001/jamacardio.2019.0052.

    PMID: 30810702RESULT

  • Su MY, Lin LY, Tseng YH, Chang CC, Wu CK, Lin JL, Tseng WY. CMR-verified diffuse myocardial fibrosis is associated with diastolic dysfunction in HFpEF. JACC Cardiovasc Imaging. 2014 Oct;7(10):991-7. doi: 10.1016/j.jcmg.2014.04.022. Epub 2014 Sep 17.

    PMID: 25240451RESULT

  • Harinstein ME, Soman P. Radionuclide Imaging Applications in Cardiomyopathies and Heart Failure. Curr Cardiol Rep. 2016 Mar;18(3):23. doi: 10.1007/s11886-016-0699-8.

    PMID: 26841785RESULT

  • Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of, Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. doi: 10.1093/ehjci/jew041. Epub 2016 Mar 15. No abstract available.

    PMID: 26983884RESULT

  • Schnelle M, Catibog N, Zhang M, Nabeebaccus AA, Anderson G, Richards DA, Sawyer G, Zhang X, Toischer K, Hasenfuss G, Monaghan MJ, Shah AM. Echocardiographic evaluation of diastolic function in mouse models of heart disease. J Mol Cell Cardiol. 2018 Jan;114:20-28. doi: 10.1016/j.yjmcc.2017.10.006. Epub 2017 Oct 19.

    PMID: 29055654RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

data of radiology imaging, clinical study and laboratory study

MeSH Terms

Conditions

Heart Failure, DiastolicDisease

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Minjie Lu, PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY CHAIR

Central Study Contacts

Minjie Lu, PhD

CONTACT

86 10 88396941coolkan@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
8 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of Magnetic Resonance Imaging

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 26, 2020

Study Start

November 1, 2020

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Our study data is applicable to other researchers with permmsion.

Locations

CN(1)