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

Heart Failure, Diastolic Clinical Trial

Official title:

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- a Multicenter Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602338
• Other study ID #: DOMAIN-HFPEF
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: June 2028

Study information

• Verified date: April 2022
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Minjie Lu, PhD
• Phone: 86 10 88396941
• Email: coolkan[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 significantly increase with the increase of age. Moreover, HFpEF patients accounted for over 50% of heart failure, 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 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 and diagnosis. However, large studies are based on single-center studies and meta analysis of small samples, and the comprehensive markers derived from multimodel study and multicenter 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 multicenter, large sample cooperative 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic
• Multicenter Study

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing Anzhen Hospital, China-Japan Friendship Hospital, Guangdong Provincial People's Hospital, Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

Altara R, Giordano M, Nordén 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. eCollecti — View Citation

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. Review. — View Citation

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. Epub 2006 Aug 1. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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;11 — View Citation

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.116.0218 — View Citation

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). pii: E242. doi: 10.3390/cells9010242. Review. — View Citation

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. — View Citation

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):678-68 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Death	the incidence of all-cause death	1-8 year
Primary	Cardiovascular Death	the incidence of cadridovascular death	1-8 year
Primary	Hospitalization Due to Heart Failure	the incidence of Hospitalization Due to Heart Failure	1-8 year
Secondary	Implantable cardioverter-defibrillator Implantation	the incidence of Implantable cardioverter-defibrillator Implantation	1-8 year
Secondary	Heart Transplantation	the incidence of Heart Transplantation	1-8 year
Secondary	Pacemaker Implantation	the incidence of Pacemaker Implantation	1-8 year
Secondary	Atrial fibrillation	the incidence of Atrial fibrillation	1-8 year