Non-ischemic CardiomyopathyNCT07351838
Cardiac Magnetic Resonance for Risk Stratification in Non-dilated Left Ventricular Cardiomyopathy
An observational study of Non-ischemic Cardiomyopathy, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Non-dilated left ventricular cardiomyopathy (NDLVC), a newly defined cardiomyopathy subtype characterized by non-ischemic myocardial abnormalities without left ventricular dilation, poses challenges in prognosis assessment and risk stratification. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Non-ischemic Cardiomyopathy
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 30 Dec 2030
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Non-dilated left ventricular cardiomyopathy (NDLVC), formally recognized in the 2023 ESC guidelines as a distinct entity,1 encapsulates patients with non-ischemic fibrosis or fatty replacement or isolated systolic dysfunction without ventricular dilatation.
Who may be able to join
- age ≥ 16 years;
- indexed left ventricular end-diastolic volume (LVEDVi) <96 mL/m2 in females and <105 mL/m2 in males at baseline cardiac magnetic resonance (CMR);
- either left ventricular ejection fraction (LVEF) <50% and/or non-ischemic left ventricular (LV) scar/fatty replacement at baseline cardiac magnetic resonance.
Who cannot join
- lacked enhanced CMR images due to contraindications for receiving gadolinium contrast, such as severe renal disease;
- ischemic heart disease, defined as stenosis of >50% in a major epicardial coronary artery underwent coronary computed tomography angiography or coronary angiography, ischemic late gadolinium enhancement (LGE) pattern on CMR indicating prior infarction, or prior coronary revascularization;
- abnormal loading conditions, defined as moderate to severe valvular heart diseases, congenital heart diseases, uncontrolled hypertension;
- systemic rheumatologic diseases or sarcoidosis;
- diagnostic criteria for other cardiomyopathies according to the European Society of Cardiology (ESC) definitions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital
Beijing, 100037
Lu Minjie PHD, +86 10 88398175, coolkan@163.com
About this study
Official title: Prognosis and Risk Stratification in Non-dilated Left Ventricular Cardiomyopathy : Cardiac MRI Insights for Better Outcomes
Non-dilated left ventricular cardiomyopathy (NDLVC), a newly defined cardiomyopathy subtype characterized by non-ischemic myocardial abnormalities without left ventricular dilation, poses challenges in prognosis assessment and risk stratification. This is a retrospective observational study aiming to explore the prognostic value of cardiac magnetic resonance (CMR) findings and identify key risk factors for adverse cardiovascular outcomes in patients with NDLVC.
We will retrospectively enroll patients diagnosed with NDLVC who underwent CMR examination at the study institution during the predefined study period. CMR parameters, including left ventricular ejection fraction (LVEF), late gadolinium enhancement (LGE) patterns, myocardial strain, and the extent of myocardial fibrosis or fatty replacement, will be extracted and analyzed. The primary endpoint is a composite of major adverse cardiovascular events (MACE), including all-cause mortality, heart transplantation, or left ventricular assist device (LVAD) implantation.
The study intends to clarify the association between specific CMR features and long-term prognosis in NDLVC patients, thereby establishing a CMR-based risk stratification strategy to guide clinical decision-making and improve patient outcomes. Given the retrospective nature, data will be collected from electronic medical records and CMR databases, with ethical approval obtained prior to study initiation.
- Conditions
- Non-ischemic Cardiomyopathy
- Being tested
- No intervention; Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; Observational studyOther
No intervention; Observational study
| Study group | Role | What they receive |
|---|---|---|
| NDLVC | Not described Receives: Other: No intervention; Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
major hard cardiac event
The primary endpoint was a composite of all-cause mortality, heart transplantation, or left ventricular assist device (LVAD) implantation. The secondary endpoint was sudden cardiac death (SCD)-related events, encompassing SCD, resuscitated cardiac arrest, ventricular fibrillation or sustained ventricular tachycardia leading to hemodynamic compromise requiring cardioversion, or appropriate implantable cardioverter-defibrillator (ICD) therapy [anti-tachycardia pacing (ATP), or shock] and heart failure (HF)-related endpoints, including HF death, heart transplant, and HF hospitalization.
Measured: From date of randomization until death, heart transplantation, implantation of a ventricular assist device, or the last clinical follow-up available, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2010
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351838
- Sponsor's protocol ID
- CMRNDLVC
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leo I, Dellegrottaglie S, Scatteia A, Torella D, Abete R, Aquaro GD, Baggiano A, Barison A, Bogaert J, Calo' L, Camastra G, Carigi S, Carrabba N, Casavecchia G, Censi S, Cicala G, De Cecco CN, De Lazzari M, Di Giovine G, Dobrovie M, Focardi M, Fusini L, Gaibazzi N, Gismondi A, Gravina M, Guglielmo M, Lanzillo C, Lombardi M, Lorenzoni V, Lozano-Torres J, Margonato D, Martini C, Marzo F, Masci PG, Masi A, Moro C, Muscogiuri G, Mushtaq S, Nese A, Palumbo A, Pavon AG, Pedrotti P, Perazzolo Marra M, Pradella S, Presicci C, Rabbat MG, Raineri C, Rodriguez-Palomares JF, Sbarbati S, Schoepf UJ, Squeri A, Sverzellati N, Symons R, Tat E, Timpani M, Todiere G, Valentini A, Varga-Szemes A, Volpe A, Guaricci AI, Schwitter J, Pontone G. CarDiac magnEtic Resonance for prophylactic Implantable cardioVerter defibrillAtor ThErapy in Non-Dilated Left Ventricular Cardiomyopathy: a sub-study from the DERIVATE registry. Eur Heart J Cardiovasc Imaging. 2025 Jun 30;26(7):1233-1241. doi: 10.1093/ehjci/jeaf043.
PubMed 39899463Castrichini M, De Luca A, De Angelis G, Neves R, Paldino A, Dal Ferro M, Barbati G, Medo K, Barison A, Grigoratos C, Gigli M, Stolfo D, Brun F, Groves DW, Quaife R, Eldemire R, Graw S, Addison J, Todiere G, Gueli IA, Botto N, Emdin M, Aquaro GD, Garmany R, Pereira NL, Taylor MRG, Ackerman MJ, Sinagra G, Mestroni L, Giudicessi JR, Merlo M. Magnetic Resonance Imaging Characterization and Clinical Outcomes of Dilated and Arrhythmogenic Left Ventricular Cardiomyopathies. J Am Coll Cardiol. 2024 May 14;83(19):1841-1851. doi: 10.1016/j.jacc.2024.02.041.
PubMed 38719365Arbelo E, Protonotarios A, Gimeno JR, Arbustini E, Barriales-Villa R, Basso C, Bezzina CR, Biagini E, Blom NA, de Boer RA, De Winter T, Elliott PM, Flather M, Garcia-Pavia P, Haugaa KH, Ingles J, Jurcut RO, Klaassen S, Limongelli G, Loeys B, Mogensen J, Olivotto I, Pantazis A, Sharma S, Van Tintelen JP, Ware JS, Kaski JP; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023 Oct 1;44(37):3503-3626. doi: 10.1093/eurheartj/ehad194. No abstract available.
PubMed 37622657
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Risk Stratification in Non-dilated Left Ventricular Cardiomyopathy : Cardiac MRI Insights for Better Outcomes
- ClinicalTrials.gov ID
- NCT07351838
- Acronym / sponsor ID
- CMRNDLVC
- Conditions
- Non-ischemic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-dilated left ventricular cardiomyopathy (NDLVC), a newly defined cardiomyopathy subtype characterized by non-ischemic myocardial abnormalities without left ventricular dilation, poses challenges in prognosis assessment and risk stratification. This is a retrospective observational study aiming to explore the prognostic value of cardiac magnetic resonance (CMR) findings and identify key risk factors for adverse cardiovascular outcomes in patients with NDLVC.
We will retrospectively enroll patients diagnosed with NDLVC who underwent CMR examination at the study institution during the predefined study period. CMR parameters, including left ventricular ejection fraction (LVEF), late gadolinium enhancement (LGE) patterns, myocardial strain, and the extent of myocardial fibrosis or fatty replacement, will be extracted and analyzed. The primary endpoint is a composite of major adverse cardiovascular events (MACE), including all-cause mortality, heart transplantation, or left ventricular assist device (LVAD) implantation.
The study intends to clarify the association between specific CMR features and long-term prognosis in NDLVC patients, thereby establishing a CMR-based risk stratification strategy to guide clinical decision-making and improve patient outcomes. Given the retrospective nature, data will be collected from electronic medical records and CMR databases, with ethical approval obtained prior to study initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NDLVC | – | Other: No intervention; Observational study |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Non-dilated left ventricular cardiomyopathy (NDLVC), formally recognized in the 2023 ESC guidelines as a distinct entity,1 encapsulates patients with non-ischemic fibrosis or fatty replacement or isolated systolic dysfunction without ventricular dilatation.
Key inclusion criteria (3 listed)
- age ≥ 16 years;
- indexed left ventricular end-diastolic volume (LVEDVi) <96 mL/m2 in females and <105 mL/m2 in males at baseline cardiac magnetic resonance (CMR);
- either left ventricular ejection fraction (LVEF) <50% and/or non-ischemic left ventricular (LV) scar/fatty replacement at baseline cardiac magnetic resonance.
Key exclusion criteria (5 listed)
- lacked enhanced CMR images due to contraindications for receiving gadolinium contrast, such as severe renal disease;
- ischemic heart disease, defined as stenosis of >50% in a major epicardial coronary artery underwent coronary computed tomography angiography or coronary angiography, ischemic late gadolinium enhancement (LGE) pattern on CMR indicating prior infarction, or prior coronary revascularization;
- abnormal loading conditions, defined as moderate to severe valvular heart diseases, congenital heart diseases, uncontrolled hypertension;
- systemic rheumatologic diseases or sarcoidosis;
- diagnostic criteria for other cardiomyopathies according to the European Society of Cardiology (ESC) definitions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; Observational studyNo intervention; Observational study | Other | NDLVC |
Primary outcome
major hard cardiac event
Time frame: From date of randomization until death, heart transplantation, implantation of a ventricular assist device, or the last clinical follow-up available, assessed up to 100 months.
The primary endpoint was a composite of all-cause mortality, heart transplantation, or left ventricular assist device (LVAD) implantation. The secondary endpoint was sudden cardiac death (SCD)-related events, encompassing SCD, resuscitated cardiac arrest, ventricular fibrillation or sustained ventricular tachycardia leading to hemodynamic compromise requiring cardioversion, or appropriate implantable cardioverter-defibrillator (ICD) therapy [anti-tachycardia pacing (ATP), or shock] and heart failure (HF)-related endpoints, including HF death, heart transplant, and HF hospitalization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Results publication: PubMed 39899463Leo I, Dellegrottaglie S, Scatteia A, Torella D, Abete R, Aquaro GD, Baggiano A, Barison A, Bogaert J, Calo' L, Camastra G, Carigi S, Carrabba N, Casavecchia G, Censi S, Cicala G, De Cecco CN, De Lazzari M, Di Giovine G, Dobrovie M, Focardi M, Fusini L, Gaibazzi N, Gismondi A, Gravina M, Guglielmo M, Lanzillo C, Lombardi M, Lorenzoni V, Lozano-Torres J, Margonato D, Martini C, Marzo F, Masci PG, Masi A, Moro C, Muscogiuri G, Mushtaq S, Nese A, Palumbo A, Pavon AG, Pedrotti P, Perazzolo Marra M, Pradella S, Presicci C, Rabbat MG, Raineri C, Rodriguez-Palomares JF, Sbarbati S, Schoepf UJ, Squeri A, Sverzellati N, Symons R, Tat E, Timpani M, Todiere G, Valentini A, Varga-Szemes A, Volpe A, Guaricci AI, Schwitter J, Pontone G. CarDiac magnEtic Resonance for prophylactic Implantable cardioVerter defibrillAtor ThErapy in Non-Dilated Left Ventricular Cardiomyopathy: a sub-study from the DERIVATE registry. Eur Heart J Cardiovasc Imaging. 2025 Jun 30;26(7):1233-1241. doi: 10.1093/ehjci/jeaf043.
- Results publication: PubMed 38719365Castrichini M, De Luca A, De Angelis G, Neves R, Paldino A, Dal Ferro M, Barbati G, Medo K, Barison A, Grigoratos C, Gigli M, Stolfo D, Brun F, Groves DW, Quaife R, Eldemire R, Graw S, Addison J, Todiere G, Gueli IA, Botto N, Emdin M, Aquaro GD, Garmany R, Pereira NL, Taylor MRG, Ackerman MJ, Sinagra G, Mestroni L, Giudicessi JR, Merlo M. Magnetic Resonance Imaging Characterization and Clinical Outcomes of Dilated and Arrhythmogenic Left Ventricular Cardiomyopathies. J Am Coll Cardiol. 2024 May 14;83(19):1841-1851. doi: 10.1016/j.jacc.2024.02.041.
- Results publication: PubMed 37622657Arbelo E, Protonotarios A, Gimeno JR, Arbustini E, Barriales-Villa R, Basso C, Bezzina CR, Biagini E, Blom NA, de Boer RA, De Winter T, Elliott PM, Flather M, Garcia-Pavia P, Haugaa KH, Ingles J, Jurcut RO, Klaassen S, Limongelli G, Loeys B, Mogensen J, Olivotto I, Pantazis A, Sharma S, Van Tintelen JP, Ware JS, Kaski JP; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023 Oct 1;44(37):3503-3626. doi: 10.1093/eurheartj/ehad194. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-ischemic Cardiomyopathy, 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 3 inclusion and 5 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 21 Jan 2026. 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 Lu Minjie 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?
major hard cardiac event (time frame: From date of randomization until death, heart transplantation, implantation of a ventricular assist device, or the last clinical follow-up available, assessed up to 100 months.). 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 NCT07351838, which also lists 3 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 21 Jan 2026.