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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 1

Conditions: Cardiomyopathy With Unknown Etiology

Treatments: Drug: etiologic treatment,anti-myocardial remodeling; Drug: anti-myocardial remodeling,anti-acute heart failure; Drug: anti-myocardial remodeling; Drug: Etiological, anti-remodeling and symptom treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02941315

2015015K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups, including a placebo group

with CMR confirmed etiology

Experimental group

Description:

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

Treatment:

Drug: etiologic treatment,anti-myocardial remodeling

etiology unconfirmed without acute HF

Placebo Comparator group

Description:

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.

Treatment:

Drug: anti-myocardial remodeling

etiology unconfirmed with acute HF

Placebo Comparator group

Description:

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.

Treatment:

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

etiology confirmed with acute HF

Experimental group

Description:

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

Treatment:

Drug: Etiological, anti-remodeling and symptom treatment