CardiomyopathyNCT02917395
Evaluate the Efficacy of Disopyramide Therapy in Hypertrophic Obstructive Cardiomyopathy Patients
A study testing echocardiography in people with Cardiomyopathy, run by Rabin Medical Center.
Trial summary
Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide. Tow echo examination, few hours apart, that includes strain rate will be done to each patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jun 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypertrophic cardiomyopathy that treated with disopyramid
Who cannot join
- pregnancy
- pacemaker
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluate the Efficacy of Disopyramide Therapy in Hypertrophic Obstructive Cardiomyopathy Patients; Comparison of Two Echocardiography Based Methods: Global Longitudinal Strain vs. Left Ventricle Ejection Fraction
Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide.
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.
Read the detailed description
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.
- Conditions
- Cardiomyopathy
- Being tested
- echocardiography
- Keywords
- hypertrophic cardiomyopathy, disopyramide,
- Medical subject headings
- Cardiomyopathies, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDevice
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.
| Study group | Role | What they receive |
|---|---|---|
| echo | Experimental | Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide.
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide. Receives: Device: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide
Measured: 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idit Yedidya, Rabin Medical Center
- Investigators
- Idit Yedidya, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917395
- Sponsor's protocol ID
- 0538-16-RMC
- Status last verified
- Oct 2016
- First submitted
- 27 Sep 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy of Disopyramide Therapy in Hypertrophic Obstructive Cardiomyopathy Patients; Comparison of Two Echocardiography Based Methods: Global Longitudinal Strain vs. Left Ventricle Ejection Fraction
- ClinicalTrials.gov ID
- NCT02917395
- Acronym / sponsor ID
- 0538-16-RMC
- Conditions
- Cardiomyopathy
- Keywords
- hypertrophic cardiomyopathy, disopyramide,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 28 Sep 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.
Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide.
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.
Detailed description
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| echo | Experimental | Device: echocardiographyPopulation study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide. Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hypertrophic cardiomyopathy that treated with disopyramid
Key exclusion criteria (2 listed)
- pregnancy
- pacemaker
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 |
|---|---|---|
| echocardiographyTow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide. | Device | echo |
Primary outcome
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide
Time frame: 2-3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Idit Yedidya, MD principal investigator
Rabin Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing echocardiography in people with Cardiomyopathy, run by Rabin Medical Center.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Idit Yedidya, md (972-3-9372242, iditye@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide (time frame: 2-3 hours). 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 4 Oct 2016.