Risk Stratification of Heart Failure in Cardiomyopathies.

NCT ID: NCT02941315

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2022-11-01

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.

Conditions

Cardiomyopathy With Unknown Etiology

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

etiologic treatment,anti-myocardial remodeling

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

anti-myocardial remodeling

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

anti-myocardial remodeling,anti-acute heart failure

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Etiological, anti-remodeling and symptom treatment

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Etiology treatment, captopril, beta-blocker; Captopril, beta-blocker; captopril, fursemide, spironolactone; Etiology treatment,captopril, fursemide, spironolactone

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng Jiang, MD

Role: STUDY_CHAIR

RenJi Hospital, School of Medicine, Shanghai Jiaotong University

Locations

Renji Hospital

Shanghai, , China

Countries

China

Other Identifiers

2015015K

Identifier Type: -

Identifier Source: org_study_id