Cardiomyopathy With Unknown EtiologyPhase 1EARLY-MYO-HFNCT02941315
Risk Stratification of Heart Failure in Cardiomyopathies.
A Phase 1 study testing etiologic treatment,anti-myocardial remodeling, anti-myocardial remodeling and anti-myocardial remodeling,anti-acute heart failure in people with Cardiomyopathy With Unknown Etiology, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Cardiomyopathy With Unknown Etiology
- What is being tested?
- etiologic treatment,anti-myocardial remodeling, anti-myocardial remodeling and anti-myocardial remodeling,anti-acute heart failure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 1 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with cardiomyopathy diagnosed by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
- no known etiology of cardiomyopathy was confirmed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- etiologic treatment,anti-myocardial remodeling, anti-myocardial remodeling, anti-myocardial remodeling,anti-acute heart failure, Etiological, anti-remodeling and symptom treatment
- Keywords
- Cardiomyopathy, Heart Failure, Cardiac Magnetic Resonance
- Medical subject headings
- Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etiologic treatment,anti-myocardial remodelingDrug
Also called Etiology treatment, captopril, beta-blocker
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.
anti-myocardial remodelingDrug
Also called Captopril, beta-blocker
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.
anti-myocardial remodeling,anti-acute heart failureDrug
Also called captopril, fursemide, spironolactone
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.
Etiological, anti-remodeling and symptom treatmentDrug
Also called Etiology treatment,captopril, fursemide, spironolactone
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.
| Study group | Role | What they receive |
|---|---|---|
| with CMR confirmed etiology | Experimental | Participants who were identified with cardiac magnetic resonance (CMR) in etiology were treated with drug including etiologic treatment,anti-myocardial remodeling. Receives: Drug: etiologic treatment,anti-myocardial remodeling |
| etiology unconfirmed without acute HF | Placebo comparator | 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. Receives: Drug: anti-myocardial remodeling |
| etiology unconfirmed with acute HF | Placebo comparator | 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. Receives: Drug: anti-myocardial remodeling,anti-acute heart failure |
| etiology confirmed with acute HF | Experimental | Participants who were identified with CMR in etiology but with acute hearts failure were treated with drug with Etiological, anti-remodeling and symptom treatment. Receives: Drug: Etiological, anti-remodeling and symptom treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospitalization due to heart failure
Evaluate the relationship between scar amount and hospitalization due to heart failure
Measured: 6 months after the first visit
Secondary outcomes (2)
malignant arrythmia
Evaluate the relationship between scar amount and malignant arrythmia
Measured: 6 months after the first visit
mortality
Evaluate the relationship between scar amount and mortality
Measured: 6 months after the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 Dec 2016
- Primary completion1 Oct 2021
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy With Unknown EtiologyStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor
- Investigators
- Meng Jiang, MD, Study chair, RenJi Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941315
- Sponsor's protocol ID
- 2015015K
- Acronym
- EARLY-MYO-HF
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2016
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure
- ClinicalTrials.gov ID
- NCT02941315
- Acronym / sponsor ID
- EARLY-MYO-HF / 2015015K
- Conditions
- Cardiomyopathy With Unknown Etiology
- Keywords
- Cardiomyopathy, Heart Failure, Cardiac Magnetic Resonance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| with CMR confirmed etiology | Experimental | Drug: etiologic treatment,anti-myocardial remodelingParticipants who were identified with cardiac magnetic resonance (CMR) in etiology were treated with drug including etiologic treatment,anti-myocardial remodeling. |
| etiology unconfirmed without acute HF | Placebo comparator | Drug: anti-myocardial remodelingParticipants 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. |
| etiology unconfirmed with acute HF | Placebo comparator | Drug: anti-myocardial remodeling,anti-acute heart failureParticipants 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. |
| etiology confirmed with acute HF | Experimental | Drug: Etiological, anti-remodeling and symptom treatmentParticipants who were identified with CMR in etiology but with acute hearts failure were treated with drug with Etiological, anti-remodeling and symptom treatment. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants with cardiomyopathy diagnosed by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
- no known etiology of cardiomyopathy was confirmed.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etiologic treatment,anti-myocardial remodelingAlso: Etiology treatment, captopril, beta-blockerWhen 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. | Drug | with CMR confirmed etiology |
| anti-myocardial remodelingAlso: Captopril, beta-blockerWhen 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. | Drug | etiology unconfirmed without acute HF |
| anti-myocardial remodeling,anti-acute heart failureAlso: captopril, fursemide, spironolactoneWhen 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. | Drug | etiology unconfirmed with acute HF |
| Etiological, anti-remodeling and symptom treatmentAlso: Etiology treatment,captopril, fursemide, spironolactoneWhen 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. | Drug | etiology confirmed with acute HF |
Primary outcome
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
2 secondary outcomes
malignant arrythmia
Time frame: 6 months after the first visit
mortality
Time frame: 6 months after the first visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Jiang, MD study chair
RenJi Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing etiologic treatment,anti-myocardial remodeling, anti-myocardial remodeling and anti-myocardial remodeling,anti-acute heart failure in people with Cardiomyopathy With Unknown Etiology, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospitalization due to heart failure (time frame: 6 months after the first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.