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

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 18 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

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

About this study

Official title: Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH Trial): a National Multi-center, Retrospective-prospective, Cohort Study

Conditions

Cardiomyopathies

Being tested

Diagnosis of HCM, Diagnosis of DCM, Diagnosis of ARVC, Diagnosis of NDLVC, Diagnosis of RCM

Keywords

Cardiomyopathies, Prognostic factors

Medical subject headings

Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Diagnosis of HCMBiological

  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.

• Diagnosis of DCMBiological

  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.

• Diagnosis of ARVCBiological

  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.

• Diagnosis of NDLVCBiological

  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.

• Diagnosis of RCMBiological

  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

• Diagnosis of LVNCBiological

  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.

What is being measured

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

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

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

Timeline

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

1. First posted8 Apr 2024
2. Study start9 May 2024
3. Primary completion31 Aug 2030 (estimated)
4. Study completion31 Aug 2032 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for CardiomyopathiesStudies of the same condition, open and under way.
• More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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.