EARLY-MYO-HF: Risk Stratification of Heart Failure in Cardiomyopathies.

Sponsor

RenJi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02941315

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathy With Unknown Etiology	Drug: etiologic treatment,anti-myocardial remodeling Drug: anti-myocardial remodeling Drug: anti-myocardial remodeling,anti-acute heart failure Drug: Etiological, anti-remodeling and symptom treatment	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure

Actual Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: etiologic 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. Other Names: Etiology treatment, captopril, beta-blocker
Placebo Comparator: 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.	Drug: anti-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. Other Names: Captopril, beta-blocker
Placebo Comparator: 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.	Drug: anti-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. Other Names: captopril, fursemide, spironolactone
Experimental: 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.	Drug: Etiological, 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. Other Names: Etiology treatment,captopril, fursemide, spironolactone

Outcome Measures

Primary Outcome Measures

hospitalization due to heart failure [6 months after the first visit]
Evaluate the relationship between scar amount and hospitalization due to heart failure

Secondary Outcome Measures

malignant arrythmia [6 months after the first visit]
Evaluate the relationship between scar amount and malignant arrythmia
mortality [6 months after the first visit]
Evaluate the relationship between scar amount and mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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