Schoolchildren in grades 7-12 in fifteen randomly selected schools in Lusaka area

Rheumatic Heart Disease

University Teaching Hosptial

Rheumatic Heart Disease Study in Lusaka

Prevalence of Rheumatic Heart Disease in Zambian Schoolchildren: an Echocardiographic Screening Study Involving Task-shifting to General Radiographers

John Musuku

Consultant Paediatrician / Cardiologist

University of Zambia

University of Cape Town

Novartis

Placebo: Capsule that is containing lactate hydrate, identically appearing with fimasartan will be administered to patient in placebo group, once daily. Same placebo drug which was used in phase 3 clinical trial of fimasartan will be provided by Boryoung Phamaceutical company. Dose titration will be done with same criteria of fimasartan group. 30mg form and 60 mg form of placebo will be identical in its morphology.

Fimasartan, Initial dose will be started with 30mg per day. At 12 months follow-up after the enrollment, dose titration up to 60 mg per day will be made with target blood pressure of 120/80.
Dose escalization from 30mg/day to 60mg/day will be performed in the case of follow-up systolic blood pressure is over 120. If the follow-up systolic blood pressure is less than 120, initial dose of 30mg/day will be maintained throughout the study duration. If hypotension (BP < 90/60) is developed, the study medication will be discontinued and the patient will be included safety outcome analysis and intention to treat analysis. Per protocol analysis will be also performed. The dose of placebo will be adjusted identically, according to the blood pressure criteria of fimasartan.

Critical Stenosis of Aortic Valve

Fimasartan

Placebo was used in phase 3 clinical trial of fimasartan (NCT00922480, NCT01135212, and NCT01258673). The same placebo, which is manufactures at Boryoung pharmaceutical company, will be used in this trial. After enrollment and randomization, placebo will be administered one capsule once daily in placebo group.

Placebo

Seoul National University Bundang Hospital

Chonnam University Hospital

Seoul National University Hospital

Samsung Medical Center, Sungkyunkwan University School of Medicine

Korea University Anam Hospital

Korea University Guro Hospital

Yonsei University Hospital

A Randomized Trial of Angiotensin Receptor bLocker,Fimasartan, in Aortic Stenosis (ALFA Trial)

Safety and Efficacy of Angiotensin Receptor Blocker, Fimasartan, on Patients With Aortic Stenosis

Change of VmaxO2 from baseline to 1 year follow-up. VmaxO2 is defined as the highest oxygen uptake, averaged over 5 consecutive breaths, during the last minute of symptom-limited cardiopulmonary exercise test. For each patient, the change in VamxO2 is calculated as (VmaxO2 at 1 year follow-up) - (VmaxO2 at baseline)

Change of peak aortic jet velocity which defined as (peak aortic jet velocity at 1 year follow-up) - (peak aortic jet velocity at baseline) on Doppler echocardiography.

Change of mean pressure gradient which will be measured in echocardiography from baseline to study end.

Change of LA area (cm2), E/E' value measured with Doppler echocardiography from baseline to study end

Change of LVMI from baseline to study end.

Development of aortic stenosis symptoms angina, dyspnea, or syncope

During 1 year follow-up, admission due to congestiv eheart failure will be evaluated as secondary clinical outcome.

During follow-up, the development of LV dysfunction in echocardiography will be evaluated.

During 1 year follow-up, the incidence of aortic valver surgery will be evaluated.

Composite Endpoint which is consist of following:
Development of symptom of aortic stenosis: angina, dyspnea, or syncope Admission for heart failure Development of left ventricular dysfunction (LVEF <50%) Aortic valve surgery Cardiac death including Sudden cardiac death (will be collected separately) All-cause death Individual components of composite endpoint will be investigated separately also

6-minutes walk distance from baseline to 1 year follow-up. For each patient, the change in 6-minutes walk distance is calculated as (6-minutes walk distance at 1 year follow-up) - (6-minutes walk distance at baseline)

Development of symptomatic hypotension (dizziness, orthostatic hypotension with BP < 90/60)
Development of overt azotemia (serum creatinine > 2.0mg/dL)
Intolerance or development of other adverse drug reactions related with study drug.

heart murmurs/inflammation

Rheumatic Heart Disease Study in Lusaka

A Randomized Trial of Angiotensin Receptor bLocker,Fimasartan, in Aortic Stenosis (ALFA Trial)

Rheumatic Heart Disease School Project

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