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Risk Stratification of Heart Failure in Cardiomyopathies.

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ClinicalTrials.gov Identifier: NCT02941315
Recruitment Status : Not yet recruiting
First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiomyopathy With Unknown Etiology Drug: etiologic treatment,anti-myocardial remodeling Drug: anti-myocardial remodeling Drug: anti-myocardial remodeling,anti-acute heart failure Drug: Etiological, anti-remodeling and symptom treatment Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Risk Stratification of Heart Failure in Cardiomyopathies With Unknown Etiology.
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: Etiology treatment, captopril, beta-blocker

Placebo Comparator: etiology unconfirmed WO 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 Name: 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 Name: 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 Name: Etiology treatment,captopril, fursemide, spironolactone




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941315


Contacts
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Contact: Meng Jiang, MD 13788912766 ext 58752445 jiangmeng0919@163.com
Contact: Xiaoying Ying, MD 18621517838 ext 58752445 akoma78@hotmail.com

Locations
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China
Renji Hospital Recruiting
Shanghai, China, 200127
Contact: Zi Wang, postgraduate       wangziz10@126.com   
Contact: Xuan Su, postgraduate       18817560226@163.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Meng Jiang, MD RenJi Hospital, School of Medicine, Shanghai Jiaotong University

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02941315     History of Changes
Other Study ID Numbers: 2015015K
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by RenJi Hospital:
Cardiomyopathy
Heart Failure
Cardiac Magnetic Resonance
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Failure
Heart Diseases
Cardiovascular Diseases
Captopril
Spironolactone
Furosemide
Adrenergic beta-Antagonists
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators