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

Sponsor

Assuta Hospital Systems (Other)

Overall Status

Unknown status

CT.gov ID

NCT03183180

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Cardiac Damage in Rheumatic Fever	Diagnostic Test: Echocardiogram

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

May 1, 2019

Outcome Measures

Primary Outcome Measures

Cardiac function including vulvar involvement [60 days]
Cardiac morphology and function measured by echocardiography

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assuta Hospital Systems

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Amir Ben-Tov, Medical Director online centers, Assuta Hospital Systems

ClinicalTrials.gov Identifier:

NCT03183180

Other Study ID Numbers:

0137-16-ASMC

First Posted:

Jun 9, 2017

Last Update Posted:

Jun 9, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2017