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Dilated CardiomyopathyNCT04990297

Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

An observational study of Dilated Cardiomyopathy and Single-center Study, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Dilated Cardiomyopathy, Single-center Study
How many people
2,500 participants
Where
1 siteChina
Study dates
24 Dec 2019to 31 Dec 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This study is a prospective, single-center, observational registry including consecutive patients with DCM who undergo clinical evaluation, blood draw for genetics and biomarker assessment, echocardiography, and CMR.

Who may be able to join

  • reduced left ventricular ejection fraction (LVEF<50%)
  • LV end-diastolic volume >2SD from normal according to normograms corrected by body surface area (BSA) and age.

Who cannot join

  • 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
  • Any evidence of hypertrophic cardiomyopathy, or moderate-to-severe valvular disease[18], or infiltrative disease (such as amyloidosis, sarcoidosis, Fabry disease)
  • Incessant arrhythmias
  • Inability to lie flat
  • Pregnancy
Show all 9Show fewer
  • 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
  • Diabetes mellitus with end organ damage
  • Inability to provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Minjie Lu, PhD contact

+86-10-88396941

coolkan@163.com

China1 site, 1 recruiting

  • Fuwai Hospital

    Beijing, Beijing Municipality, 100037

    Minjie Lu, PhD, +86 10 88398175, coolkan@163.com

    Recruiting

Other trials in China

About this study

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.

Keywords
dilated cardiomyopathy, cardiovascular magnetic resonance imaging, prognosis
Medical subject headings
Cardiomyopathy, Dilated

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1-10years

Secondary outcomes (3)

  1. 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

    Measured: 1-10years

  2. Deterioration of HF

    HF-death, heart transplantation, left ventricular assist device

    Measured: 1-10years

  3. Major adverse cardiac events

    all-cause mortality, heart transplantation, left ventricular assist device, aborted SCD, sustained ventricular tachycardia and hospitalization for heart failure

    Measured: 1-10years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2021
  2. Study start24 Dec 2019
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04990297
Sponsor's protocol ID
CREATE
Status last verified
Oct 2022
First submitted
27 Jul 2021
Last updated
31 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Our study data is applicable to other researchers with permmsion.

Publications

  • 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.jacc.2017.08.074. Epub 2017 Nov 12.

    PubMed 29141781

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-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; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

    PubMed 27207191

  • 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 Unexpected Death Study. J Am Coll Cardiol. 2006 Mar 21;47(6):1161-6. doi: 10.1016/j.jacc.2005.11.045. Epub 2006 Feb 23.

    PubMed 16545646

  • 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.2014.04.008. Epub 2014 Sep 3.

    PubMed 25194291

  • 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. doi: 10.2174/1381612821666150710150445.

    PubMed 26166604

  • 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.

    PubMed 30810702

  • 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 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.

    PubMed 30545455

  • Gormeli CA, Ozdemir ZM, Kahraman AS, Yagmur J, Ozdemir R, Colak 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 Oct 27.

    PubMed 27785679

  • 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 Oct;16(10):681-7. doi: 10.2459/JCM.0000000000000275.

    PubMed 26090916

  • 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 patients with dilated cardiomyopathy. Heart Vessels. 2018 Oct;33(10):1195-1203. doi: 10.1007/s00380-018-1154-0. Epub 2018 Mar 20.

    PubMed 29560528

  • Vita T, Grani 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 Myocardial Patterns Toward Heart Failure Outcomes in Nonischemic Dilated Cardiomyopathy. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 2):1659-1669. doi: 10.1016/j.jcmg.2018.08.021. Epub 2018 Nov 15.

    PubMed 30448130

  • Zhou D, Zhang H, Yang W, Wang Y, Zhu L, Jiang M, Xu J, Teng F, Zhao X, Zhu S, Liu D, Zhang Q, Sirajuddin A, Arai AE, Zhao S, Lu M. Risk Stratification of Sudden Cardiac Death in Nonischemic Dilated Cardiomyopathy: Arrhythmogenic Substrate Assessment in Cardiac MRI. Radiology. 2025 Sep;316(3):e243427. doi: 10.1148/radiol.243427.

    PubMed 40923889

Questions about this trial

What is this clinical trial studying?

An observational study of Dilated Cardiomyopathy and Single-center Study, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Minjie Lu, PhD (+86-10-88396941, coolkan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (time frame: 1-10years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04990297, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.

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