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Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Penicillin Secondary Prophylaxis

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ClinicalTrials.gov Identifier: NCT03183180
Recruitment Status : Not yet recruiting
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Amir Ben-Tov, Assuta Hospital Systems

Tracking Information
First Submitted Date June 7, 2017
First Posted Date June 9, 2017
Last Update Posted Date June 9, 2017
Estimated Study Start Date June 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2017)
Cardiac function including vulvar involvement [ Time Frame: 60 days ]
Cardiac morphology and function measured by echocardiography
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Penicillin Secondary Prophylaxis
Official Title Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Adherence to Penicillin Secondary Prophylaxis
Brief 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.

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients older than 21 years who were diagnosed with RF (before age 18 years) acoording to the computerized database.
Condition Secondary Cardiac Damage in Rheumatic Fever
Intervention Diagnostic Test: Echocardiogram
Current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 8, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2019
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- Patients older than 21 years who were diagnosed with RF (before age 18 years) according to the computerized database.

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03183180
Other Study ID Numbers 0137-16-ASMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dr. Amir Ben-Tov, Assuta Hospital Systems
Study Sponsor Assuta Hospital Systems
Collaborators Not Provided
Investigators Not Provided
PRS Account Assuta Hospital Systems
Verification Date June 2017