Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

Dilated Cardiomyopathy Clinical Trial

Official title:

Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990297
• Other study ID #: CREATE
• Status: Recruiting
• Start date: December 24, 2019
• Est. completion date: December 31, 2031

Study information

• Verified date: October 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

Clinical Trial Summary

Dilated cardiomyopathy (DCM) is an increasingly recognized cause of morbidity and mortality with heterogenous etiologies (eg, genetic, environment) and clinical manifestations, characterized by left ventricular (LV) systolic dysfunction and LV or biventricular dilation. Previous publications reported the three-year treated mortality rates remain high at 12%-20% and a reported 5-year mortality rate up to 50%, with death resulting from ventricular arrhythmia leading to sudden cardiac death (SCD) or advanced heart failure (HF). With large fields of view and high spatial resolution, Cardiac magnetic resonance (CMR) is the reference standard for assessing cardiac mass, volume, and function. CMR also provides non noninvasive characterization of the myocardium benefiting to differential diagnosis and risk stratification.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. reduced left ventricular ejection fraction (LVEF<50%)

2. LV end-diastolic volume >2SD from normal according to normograms corrected by body surface area (BSA) and age.

Exclusion Criteria:

1. Any evidence indicating the presence of ischemic heart disease:

Coronary angiography, perfusion imaging Medical documentation that indicated the presence of ischemic heart disease An infarct pattern of late gadolinium enhancement on cardiac magnetic resonance studies and/or acute coronary syndrome or coronary revascularization during follow-up

2. Any evidence of hypertrophic cardiomyopathy, or moderate-to-severe valvular disease[18], or infiltrative disease (such as amyloidosis, sarcoidosis, Fabry disease)

3. Incessant arrhythmias

4. Inability to lie flat

5. Pregnancy

6. Contraindication to cardiac magnetic resonance including severe claustrophobia, defibrillators, pacemakers, certain types of intracranial aneurysm clips, intraocular metal, and Stage IV/V chronic kidney disease

7. Diabetes mellitus with end organ damage

8. Inability to provide informed consent.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

Barison A, Del Torto A, Chiappino S, Aquaro GD, Todiere G, Vergaro G, Passino C, Lombardi M, Emdin M, Masci PG. Prognostic significance of myocardial extracellular volume fraction in nonischaemic dilated cardiomyopathy. J Cardiovasc Med (Hagerstown). 2015 — View Citation

Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 — View Citation

Fukushima A, Milner K, Gupta A, Lopaschuk GD. Myocardial Energy Substrate Metabolism in Heart Failure : from Pathways to Therapeutic Targets. Curr Pharm Des. 2015;21(25):3654-64. Review. — View Citation

Görmeli CA, Özdemir ZM, Kahraman AS, Yagmur J, Özdemir R, Çolak C. The evaluation of non-ischemic dilated cardiomyopathy with T1 mapping and ECV methods using 3T cardiac MRI. Radiol Med. 2017 Feb;122(2):106-112. doi: 10.1007/s11547-016-0701-y. Epub 2016 O — View Citation

Inui K, Asai K, Tachi M, Yoshinaga A, Izumi Y, Kubota Y, Murai K, Tsukada YT, Amano Y, Kumita S, Shimizu W. Extracellular volume fraction assessed using cardiovascular magnetic resonance can predict improvement in left ventricular ejection fraction in pat — 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

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; — View Citation

Rahimi K, Bennett D, Conrad N, Williams TM, Basu J, Dwight J, Woodward M, Patel A, McMurray J, MacMahon S. Risk prediction in patients with heart failure: a systematic review and analysis. JACC Heart Fail. 2014 Oct;2(5):440-6. doi: 10.1016/j.jchf.2014.04. — View Citation

Shah KS, Xu H, Matsouaka RA, Bhatt DL, Heidenreich PA, Hernandez AF, Devore AD, Yancy CW, Fonarow GC. Heart Failure With Preserved, Borderline, and Reduced Ejection Fraction: 5-Year Outcomes. J Am Coll Cardiol. 2017 Nov 14;70(20):2476-2486. doi: 10.1016/j — View Citation

Stecker EC, Vickers C, Waltz J, Socoteanu C, John BT, Mariani R, McAnulty JH, Gunson K, Jui J, Chugh SS. Population-based analysis of sudden cardiac death with and without left ventricular systolic dysfunction: two-year findings from the Oregon Sudden Une — View Citation

Vita T, Gräni C, Abbasi SA, Neilan TG, Rowin E, Kaneko K, Coelho-Filho O, Watanabe E, Mongeon FP, Farhad H, Rassi CH, Choi YL, Cheng K, Givertz MM, Blankstein R, Steigner M, Aghayev A, Jerosch-Herold M, Kwong RY. Comparing CMR Mapping Methods and Myocardi — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality	the incidence of all-cause death the incidence of all-cause death the incidence of all-cause death the incidence of all-cause mortality	1-10years
Secondary	A composite of SCD and aborted SCD	SCD, defined as unexpected death within =1 hour of cardiac symptoms in the absence of any progressive cardiac deterioration, during sleep, or =24 hours of last being seen alive. Aborted SCD, defined as an appropriate implantable cardioverter defibrillator shock for ventricular arrhythmia, a nonfatal episode of ventricular fibrillation or spontaneous sustained ventricular tachycardia causing hemodynamic compromise and requiring cardioversion	1-10years
Secondary	Deterioration of HF	HF-death, heart transplantation, left ventricular assist device	1-10years
Secondary	Major adverse cardiac events	all-cause mortality, heart transplantation, left ventricular assist device, aborted SCD, sustained ventricular tachycardia and hospitalization for heart failure	1-10years