Heart; ComplicationsNCT03247153
Influence of Corticosteroids on Heart Function
A study testing Echocardiography in people with Heart; Complications, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
This study will examine the effect of corticosteroid treatment on heart function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Complications
- What is being tested?
- Echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2017to Aug 2019
- 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
- Patients with good echogenic body structure
- Patients with sinus rhythm with no conduction disorder
Who cannot join
- Patients with major medical condition
- Patients who are not hemodynamical stable
- Patients receiving long-term corticosteroid therapy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Natalia Kastsyuchenka, MD, 972-630-8350, nataluyshkka@gmail.com
About this study
Official title: Influence of Corticosteroid Therapy on Heart Function
This study will examine the effect of corticosteroid treatment on heart function.
- Conditions
- Heart; Complications
- Being tested
- Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Imaging of the heart using ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Therapy Patients | Experimental | Corticosteroid therapy patients will be examined by echocardiography before, during and after receiving treatment Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart function
Comparison of echocardiography performed before, during, and after corticosteroid administration will display changes in heart function
Measured: One month after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study startAug 2017 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; ComplicationsStudies 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nina Avshovitch, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247153
- Sponsor's protocol ID
- HYMC-52-17
- Status last verified
- Aug 2017
- First submitted
- 9 Aug 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Corticosteroid Therapy on Heart Function
- ClinicalTrials.gov ID
- NCT03247153
- Acronym / sponsor ID
- HYMC-52-17
- Conditions
- Heart; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2017 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 11 Aug 2017 (actual)
- 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.
This study will examine the effect of corticosteroid treatment on heart function.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Therapy Patients | Experimental | Diagnostic Test: EchocardiographyCorticosteroid therapy patients will be examined by echocardiography before, during and after receiving treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with good echogenic body structure
- Patients with sinus rhythm with no conduction disorder
Key exclusion criteria (3 listed)
- Patients with major medical condition
- Patients who are not hemodynamical stable
- Patients receiving long-term corticosteroid therapy
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 |
|---|---|---|
| EchocardiographyImaging of the heart using ultrasound | Diagnostic test | Corticosteroid Therapy Patients |
Primary outcome
Changes in heart function
Time frame: One month after completion of treatment
Comparison of echocardiography performed before, during, and after corticosteroid administration will display changes in heart function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- 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.
Nina Avshovitch, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography in people with Heart; Complications, run by Hillel Yaffe Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 11 Aug 2017. 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 Israel. 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. 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 Natalia Kastsyuchenka, MD (972-630-8350, nataluyshkka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart function (time frame: One month after completion of treatment). 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 11 Aug 2017.