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Clinical Trials/NCT02941315
NCT02941315
Completed
Phase 1

EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure

RenJi Hospital1 site in 1 country150 target enrollmentDecember 1, 2016

Overview

Phase
Phase 1
Intervention
anti-myocardial remodeling
Conditions
Cardiomyopathy With Unknown Etiology
Sponsor
RenJi Hospital
Enrollment
150
Locations
1
Primary Endpoint
hospitalization due to heart failure
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
November 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

etiology unconfirmed without acute HF

Participants who were not identified with cardiac magnetic resonance (CMR) in etiology and without acute hearts failure (HF) were treated with drug with anti-myocardial remodeling.

Intervention: anti-myocardial remodeling

with CMR confirmed etiology

Participants who were identified with cardiac magnetic resonance (CMR) in etiology were treated with drug including etiologic treatment,anti-myocardial remodeling.

Intervention: etiologic treatment,anti-myocardial remodeling

etiology unconfirmed with acute HF

Participants who were not identified with CMR in etiology but with acute hearts failure were treated with drug with anti-myocardial remodeling,anti-acute heart failure.

Intervention: anti-myocardial remodeling,anti-acute heart failure

etiology confirmed with acute HF

Participants who were identified with CMR in etiology but with acute hearts failure were treated with drug with Etiological, anti-remodeling and symptom treatment.

Intervention: Etiological, anti-remodeling and symptom treatment

Outcomes

Primary Outcomes

hospitalization due to heart failure

Time Frame: 6 months after the first visit

Evaluate the relationship between scar amount and hospitalization due to heart failure

Secondary Outcomes

  • mortality(6 months after the first visit)
  • malignant arrythmia(6 months after the first visit)

Study Sites (1)

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