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RecruitingNCT06352320Updated Jul 12, 2024

Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH)

An observational study in Cardiomyopathies, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment.

Read the detailed description

This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment.

02

Conditions studied

  • Cardiomyopathies

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Keywords

  • Cardiomyopathies
  • Prognostic factors
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 500 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with cardiomyopathy at all centers including The First Affiliated Hospital of Xi'an Jiaotong University.

Inclusion criteria

  • Age >18 years old.
  • The diagnosis of cardiomyopathy was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing.
  • Patients or their families agreed to participate in the study and authorized informed consent.

Exclusion criteria

Exclusion Criteria:

  • Incomplete clinical data.
  • Do not agree to the inclusion or refuse to authorize the informed consent.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • HCM group

    Patients were diagnosed with HCM.

    Biological: Diagnosis of HCM

  • DCM group

    Patients were diagnosed with DCM.

    Biological: Diagnosis of DCM

  • ARVC group

    Patients were diagnosed with ARVC.

    Biological: Diagnosis of ARVC

  • NDLVC group

    Patients were diagnosed with NDLVC.

    Biological: Diagnosis of NDLVC

  • RCM group

    Patients were diagnosed with RCM.

    Biological: Diagnosis of RCM

  • LVNC group

    Patients were diagnosed with LNVC.

    Biological: Diagnosis of LVNC

Interventions

  • BiologicalDiagnosis of HCM

    Hypertrophic cardiomyopathy (HCM) is defined as the presence of increased LV wall thickness (with or without RV hypertrophy) or mass that is not solely explained by abnormal loading conditions.

  • BiologicalDiagnosis of DCM

    Dilated cardiomyopathy (DCM) is defined as the presence of LV dilatation and global or regional systolic dysfunction unexplained solely by abnormal loading conditions (e.g. hypertension, valve disease, CHD) or CAD.Very rarely, LV dilatation can occur with normal ejection fraction (EF) in the absence of athletic remodelling or other environmental factors; this is not in itself a cardiomyopathy, but may represent an early manifestation of DCM. The preferred term for this is isolated left ventricular dilatation. Right ventricular dilatation and dysfunction may be present but are not necessary for the diagnosis.

  • BiologicalDiagnosis of ARVC

    Arrhythmogenic right ventricular cardiomyopathy (ARVC) is defined as the presence of predominantly RV dilatation and/or dysfunction in the presence of histological involvement and/or electrocardiographic abnormalities in accordance with published criteria.

  • BiologicalDiagnosis of NDLVC

    The NDLVC phenotype is defined as the presence of non-ischaemic LV scarring or fatty replacement regardless of the presence of global or regional wall motion abnormalities (RWMAs), or isolated global LV hypokinesia without scarring.

  • BiologicalDiagnosis of RCM

    Restrictive cardiomyopathy (RCM) is defined as restrictive left and/or RV pathophysiology in the presence of normal or reduced diastolic volumes (of one or both ventricles), normal or reduced systolic volumes, and normal ventricular wall thickness.Restrictive cardiomyopathy commonly presents as biatrial enlargement. Left ventricular systolic function can be preserved, but it is rare for contractility to be completely normal. Restrictive pathophysiology may not be present throughout the natural history, but only at an initial stage (with an evolution towards a hypokinetic-dilated phase). Restrictive physiology can also occur in patients with end-stage hypertrophic and dilated cardiomyopathy; the preferred terms are 'hypertrophic' or 'dilated cardiomyopathy with restrictive physiology'. Restrictive ventricular physiology can also be caused by endocardial pathology (fibrosis, fibroelastosis, and thrombosis) that impairs diastolic function

  • BiologicalDiagnosis of LVNC

    The term 'left ventricular non-compaction' (LVNC) has been used to describe a ventricular phenotype characterized by prominent LV trabeculae and deep intertrabecular recesses. The myocardial wall is often thickened with a thin,compacted epicardial layer and a thickerendocardial layer. Left ventricular non-compaction is frequently a familial trait and is associated with variants in a range of genes, including those encoding proteins of the sarcomere, Z-disc, cytoskeleton, and nuclear envelope. Left ventricular non-compaction has also been used to describe an acquired and sometimes transient phenomenon of excessive LV trabeculation (e.g. in athletes, during pregnancy, or following vigorous activity)that must reflect increased prominence of an otherwise normal myocardial architecture, given that cardiomyocytes are terminally differentiated and the formation of new cardiac structures is impossible.The Task Force does not consider LVNC to be a cardiomyopathy in the general sense.

06

What researchers measure

Primary outcomes

  1. Change in the incidence of mortality rate

    The survival status will be obtained from the medical records and phone calls to patients or their family members

    Time frame: At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3, 5, 10 year.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06352320
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Apr 8, 2024
Start date
May 9, 2024
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2032 (estimated)
Last update
Jul 12, 2024

Study contacts

Yang Yan
Contact
yangyan3@xjtu.edu.cn
+862985323869
Guoliang Li
Contact
liguoliang_med@163.com
+862985323869
Yang Yan
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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