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

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.

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 Overview

• Status: Unknown
• Conditions: Secondary Cardiac Damage in Rheumatic Fever
• Intervention / Treatment: Diagnostic test: Echocardiogram

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac function including vulvar involvement	Cardiac morphology and function measured by echocardiography	60 days

Collaborators and Investigators

• Sponsor: Assuta Hospital Systems

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Neoplastic Processes; Body Temperature Changes; Neoplasm Metastasis; Rheumatic Diseases; Fever; Rheumatic Fever
• Other Study ID Numbers: 0137-16-ASMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No