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Risk Stratification of Heart Failure in Cardiomyopathies.

EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02941315
Acronym
EARLY-MYO-HF
Enrollment
150
Registered
2016-10-21
Start date
2016-12-01
Completion date
2022-11-01
Last updated
2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy With Unknown Etiology

Keywords

Cardiomyopathy, Heart Failure, Cardiac Magnetic Resonance

Brief summary

The investigators aimed to use CMR technique in helping diagnose the etiology of unknown cardiomyopathy. Try to make a risk stratification of susceptible heart failure based on the extent of myocardial impairment.

Detailed description

Cardiomyopathy is a category of multiple causes of myocardial injury in structure and function, of which unexplained cardiomyopathy was most worried by cardiologists. Since the etiology confirmation sometimes still lacks of effective tools, therefore it can not be treated against etiology and may gradually developing to systolic or diastolic heart failure. The development of heart failure can be in different speeds, varying degrees, inconsistent in reversibility, and distinct response to treatment of heart failure. In real-world, ECG , cardiac ultrasound and myocardial enzymology can not be the whole to indicate the etiology of heart failure, so a strong clinical tool in the existing auxiliary examination is urgently needed and help to assess the risk of potential heart failure, therefore a reasonable treatment time window can be proposed. The investigators aimed to use CMR technique in helping diagnose the etiology of unknown cardiomyopathy. Try to make a risk stratification of susceptible heart failure based on the extent of myocardial impairment.

Interventions

DRUGetiologic treatment,anti-myocardial remodeling

When the etiology was diagnosed clearly by cardiac magnetic resonance(CMR), participants were treated with drugs including etiologic treatment,anti-myocardial remodeling according to guidelines for treatment of cardiomyopathy.

DRUGanti-myocardial remodeling

When the etiology was not diagnosed clearly by cardiac magnetic resonance(CMR), in participant without companioned with acute heart failure, participants were treated with drugs including anti-myocardial remodeling according to guidelines for treatment of cardiomyopathy.

DRUGanti-myocardial remodeling,anti-acute heart failure

When the etiology was not diagnosed clearly by cardiac magnetic resonance(CMR), in participant companioned with acute heart failure, participants were treated with drugs including anti-myocardial remodeling and anti- acute failure according to guidelines.

DRUGEtiological, anti-remodeling and symptom treatment

When the etiology was diagnosed clearly by cardiac magnetic resonance(CMR), in participants were companioned with acute heart failure, the participant should be treated with drugs including etiologic treatment,anti-myocardial remodeling and anti-acute heart failure according to guidelines for treatment of cardiomyopathy.

Sponsors

Ruijin Hospital
CollaboratorOTHER
RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Participants with cardiomyopathy diagnosed by medical history, clinical symptoms, laboratory tests including ECG, echocardiography. * no known etiology of cardiomyopathy was confirmed.

Exclusion criteria

* with contraindications of magnetic resonance include: 1, participants with cardiac pacemakers and nerve stimulator; 2, participants who have done aneurysm surgery and intracranial with aneurysm folder; 3, participants with the metal foreign body in the eye; 4, pregnant women; 5, critically ill participants need life support systems; 6, epilepsy participants; 7, claustrophobic participants;. * participants who are \<15 years of age or \>75 years. * participants who have the contraindication use of contrast media: glomerular filtration rate \<30 ml/min

Design outcomes

Primary

MeasureTime frameDescription
hospitalization due to heart failure6 months after the first visitEvaluate the relationship between scar amount and hospitalization due to heart failure

Secondary

MeasureTime frameDescription
malignant arrythmia6 months after the first visitEvaluate the relationship between scar amount and malignant arrythmia
mortality6 months after the first visitEvaluate the relationship between scar amount and mortality

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026