Risk Stratification of Heart Failure in Cardiomyopathies.

Cardiomyopathy With Unknown Etiology Clinical Trial

— EARLY-MYO-HF  

Official title:

EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941315
• Other study ID #: 2015015K
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2016
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy With Unknown Etiology
• Heart Failure

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
RenJi Hospital	Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospitalization due to heart failure	Evaluate the relationship between scar amount and hospitalization due to heart failure	6 months after the first visit
Secondary	malignant arrythmia	Evaluate the relationship between scar amount and malignant arrythmia	6 months after the first visit
Secondary	mortality	Evaluate the relationship between scar amount and mortality	6 months after the first visit