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

Primary Purpose

Cardiomyopathy With Unknown Etiology

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
etiologic treatment,anti-myocardial remodeling
anti-myocardial remodeling
anti-myocardial remodeling,anti-acute heart failure
Etiological, anti-remodeling and symptom treatment
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiomyopathy With Unknown Etiology focused on measuring Cardiomyopathy, Heart Failure, Cardiac Magnetic Resonance

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Renji Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Experimental

Arm Label

with CMR confirmed etiology

etiology unconfirmed without acute HF

etiology unconfirmed with acute HF

etiology confirmed with acute HF

Arm Description

Participants who were identified with cardiac magnetic resonance (CMR) in etiology were treated with drug including etiologic treatment,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.

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.

Participants who were identified with CMR in etiology but with acute hearts failure were treated with drug with Etiological, anti-remodeling and symptom treatment.

Outcomes

Primary Outcome Measures

hospitalization due to heart failure
Evaluate the relationship between scar amount and hospitalization due to heart failure

Secondary Outcome Measures

malignant arrythmia
Evaluate the relationship between scar amount and malignant arrythmia
mortality
Evaluate the relationship between scar amount and mortality

Full Information

First Posted
October 12, 2016
Last Updated
May 30, 2023
Sponsor
RenJi Hospital
Collaborators
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02941315
Brief Title
Risk Stratification of Heart Failure in Cardiomyopathies.
Acronym
EARLY-MYO-HF
Official Title
EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Ruijin Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy With Unknown Etiology
Keywords
Cardiomyopathy, Heart Failure, Cardiac Magnetic Resonance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
with CMR confirmed etiology
Arm Type
Experimental
Arm Description
Participants who were identified with cardiac magnetic resonance (CMR) in etiology were treated with drug including etiologic treatment,anti-myocardial remodeling.
Arm Title
etiology unconfirmed without acute HF
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
etiology unconfirmed with acute HF
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
etiology confirmed with acute HF
Arm Type
Experimental
Arm Description
Participants who were identified with CMR in etiology but with acute hearts failure were treated with drug with Etiological, anti-remodeling and symptom treatment.
Intervention Type
Drug
Intervention Name(s)
etiologic treatment,anti-myocardial remodeling
Other Intervention Name(s)
Etiology treatment, captopril, beta-blocker
Intervention Description
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
Intervention Name(s)
anti-myocardial remodeling
Other Intervention Name(s)
Captopril, beta-blocker
Intervention Description
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
Intervention Name(s)
anti-myocardial remodeling,anti-acute heart failure
Other Intervention Name(s)
captopril, fursemide, spironolactone
Intervention Description
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
Intervention Name(s)
Etiological, anti-remodeling and symptom treatment
Other Intervention Name(s)
Etiology treatment,captopril, fursemide, spironolactone
Intervention Description
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.
Primary Outcome Measure Information:
Title
hospitalization due to heart failure
Description
Evaluate the relationship between scar amount and hospitalization due to heart failure
Time Frame
6 months after the first visit
Secondary Outcome Measure Information:
Title
malignant arrythmia
Description
Evaluate the relationship between scar amount and malignant arrythmia
Time Frame
6 months after the first visit
Title
mortality
Description
Evaluate the relationship between scar amount and mortality
Time Frame
6 months after the first visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Jiang, MD
Organizational Affiliation
RenJi Hospital, School of Medicine, Shanghai Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Risk Stratification of Heart Failure in Cardiomyopathies.

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