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

May 30, 2023 updated by: RenJi Hospital

EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200127
        • Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Etiology treatment, captopril, beta-blocker
Placebo Comparator: 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.
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.
Other Names:
  • Captopril, beta-blocker
Placebo Comparator: 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.
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.
Other Names:
  • captopril, fursemide, spironolactone
Experimental: 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.
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.
Other Names:
  • Etiology treatment,captopril, fursemide, spironolactone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospitalization due to heart failure
Time Frame: 6 months after the first visit
Evaluate the relationship between scar amount and hospitalization due to heart failure
6 months after the first visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
malignant arrythmia
Time Frame: 6 months after the first visit
Evaluate the relationship between scar amount and malignant arrythmia
6 months after the first visit
mortality
Time Frame: 6 months after the first visit
Evaluate the relationship between scar amount and mortality
6 months after the first visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Ruijin Hospital

Investigators

  • Study Chair: Meng Jiang, MD, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimated)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015015K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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