Risk Stratification of Heart Failure in Cardiomyopathies.

Phase 1

Completed

• Conditions: Cardiomyopathy With Unknown Etiology
• Interventions: Drug: etiologic treatment,anti-myocardial remodeling; Drug: anti-myocardial remodeling; Drug: Etiological, anti-remodeling and symptom treatment; Drug: anti-myocardial remodeling,anti-acute heart failure

• Registration Number: NCT02941315
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Study Start: 2016-12-01
• Primary Completion: 2021-10-01
• Status Verified: 2022-11
• Study Completion: 2022-11-01
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with CMR confirmed etiology	etiologic treatment,anti-myocardial remodeling	Participants who were identified with cardiac magnetic resonance (CMR) in etiology were treated with drug including etiologic treatment,anti-myocardial remodeling.
etiology unconfirmed without acute HF	anti-myocardial remodeling	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.
etiology confirmed with acute HF	Etiological, anti-remodeling and symptom treatment	Participants who were identified with CMR in etiology but with acute hearts failure were treated with drug with Etiological, anti-remodeling and symptom treatment.
etiology unconfirmed with acute HF	anti-myocardial remodeling,anti-acute heart failure	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
mortality	6 months after the first visit	Evaluate the relationship between scar amount and mortality
malignant arrythmia	6 months after the first visit	Evaluate the relationship between scar amount and malignant arrythmia

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China