Secondary Cardiac Damage in Rheumatic FeverNCT03183180
Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Penicillin Secondary Prophylaxis
An observational study of Secondary Cardiac Damage in Rheumatic Fever, run by Assuta Hospital Systems.
Trial summary
According to American Heart Association criteria, patients who have had Rheumatic Fever (RF) should be treated with antibiotic prophylaxis. Continuous prophylaxis is recommended in patients with well-documented histories of RF and in those with evidence of rheumatic heart disease. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Secondary Cardiac Damage in Rheumatic Fever
- What is being tested?
- Echocardiogram
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to May 2019
- Phase
- Observational
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 21 years who were diagnosed with RF (before age 18 years) acoording to the computerized database.
Who may be able to join
- Patients older than 21 years who were diagnosed with RF (before age 18 years) according to the computerized database.
Who cannot join
- patients with other rheumatic disease diagnosed before RF diagnosis
- patients with other cardiac disease diagnosed before RF diagnosis
- patients with neoplastic disease diagnosed before RF diagnosis
About this study
Official title: Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Adherence to Penicillin Secondary Prophylaxis
According to American Heart Association criteria, patients who have had Rheumatic Fever (RF) should be treated with antibiotic prophylaxis. Continuous prophylaxis is recommended in patients with well-documented histories of RF and in those with evidence of rheumatic heart disease.
There is a limited data regarding adherence of patients to treatment and efficacy of treatment.
Read more
In this study, patients with RF who are older than 21 years will be collected from a computerized database of 'Maccabi Healthcare Services', one of the biggest Israeli Health Funds. Patients will be assigned to the study after obtaining informed consent.
Previous adherence to antibiotic prophylaxis will be examined according to computerized database of drugs which were issued to the patient since RF diagnosis.
Past history of cardiac involvement, including past Echocardiograms, will be collected from computerized database. In addition, the current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination.
- Being tested
- Echocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramDiagnostic test
Current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function including vulvar involvement
Cardiac morphology and function measured by echocardiography
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Cardiac Damage in Rheumatic FeverStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amir Ben-Tov, Assuta Hospital Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183180
- Sponsor's protocol ID
- 0137-16-ASMC
- Status last verified
- Jun 2017
- First submitted
- 7 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Adherence to Penicillin Secondary Prophylaxis
- ClinicalTrials.gov ID
- NCT03183180
- Acronym / sponsor ID
- 0137-16-ASMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 9 Jun 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.
According to American Heart Association criteria, patients who have had Rheumatic Fever (RF) should be treated with antibiotic prophylaxis. Continuous prophylaxis is recommended in patients with well-documented histories of RF and in those with evidence of rheumatic heart disease.
There is a limited data regarding adherence of patients to treatment and efficacy of treatment.
In this study, patients with RF who are older than 21 years will be collected from a computerized database of 'Maccabi Healthcare Services', one of the biggest Israeli Health Funds. Patients will be assigned to the study after obtaining informed consent.
Previous adherence to antibiotic prophylaxis will be examined according to computerized database of drugs which were issued to the patient since RF diagnosis.
Past history of cardiac involvement, including past Echocardiograms, will be collected from computerized database. In addition, the current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 21 years who were diagnosed with RF (before age 18 years) acoording to the computerized database.
Key inclusion criteria (1 listed)
- Patients older than 21 years who were diagnosed with RF (before age 18 years) according to the computerized database.
Key exclusion criteria (3 listed)
- patients with other rheumatic disease diagnosed before RF diagnosis
- patients with other cardiac disease diagnosed before RF diagnosis
- patients with neoplastic disease diagnosed before RF diagnosis
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 |
|---|---|---|
| EchocardiogramCurrent cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination | Diagnostic test | – |
Primary outcome
Cardiac function including vulvar involvement
Time frame: 60 days
Cardiac morphology and function measured by echocardiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Cardiac Damage in Rheumatic Fever, run by Assuta Hospital Systems.
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 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 9 Jun 2017. 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?
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?
Cardiac function including vulvar involvement (time frame: 60 days). 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 9 Jun 2017.