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

Secondary Cardiac Damage in Rheumatic Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03183180
• Other study ID #: 0137-16-ASMC
• Status: Not yet recruiting
• Phase: N/A
• First received: June 7, 2017
• Last updated: June 8, 2017
• Start date: June 2017
• Est. completion date: May 2019

Study information

• Verified date: June 2017
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Neoplasm Metastasis
• Rheumatic Diseases
• Rheumatic Fever
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function including vulvar involvement	Cardiac morphology and function measured by echocardiography	60 days