Clinical trial NCT02941315: Risk Stratification of Heart Failure in Cardiomyopathies.
Official title: EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiomyopathy With Unknown Etiology
Keywords: Cardiomyopathy
Heart Failure
Cardiac Magnetic Resonance
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2016-10-21
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: hospitalization due to heart failure
timeFrame: 6 months after the first visit
Secondary outcomes:
measure: malignant arrythmia
timeFrame: 6 months after the first visit
measure: mortality
timeFrame: 6 months after the first visit
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiaotong University
name: Meng Jiang, MD
role: STUDY_CHAIR
References: