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Completed

NCT Number: NCT02941315

Risk Stratification of Heart Failure in Cardiomyopathies.

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.

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Key information

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Renji Hospital

Shanghai, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etiologic treatment,anti-myocardial remodeling

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.

Other names: Etiology treatment, captopril, beta-blocker

anti-myocardial remodeling

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.

Other names: Captopril, beta-blocker

anti-myocardial remodeling,anti-acute heart failure

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.

Other names: captopril, fursemide, spironolactone

Etiological, anti-remodeling and symptom treatment

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.

Other names: Etiology treatment,captopril, fursemide, spironolactone

Primary outcomes

  1. 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

Secondary outcomes

  1. malignant arrythmia

    Time frame: 6 months after the first visit

    Evaluate the relationship between scar amount and malignant arrythmia

  2. mortality

    Time frame: 6 months after the first visit

    Evaluate the relationship between scar amount and mortality

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Ruijin Hospital

Registry information

Official study title

EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure

Acronym: EARLY-MYO-HF

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Oct 21, 2016
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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