Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG

Completed

• Conditions: Left Ventricular Hypertrophy; Hypertension

• Registration Number: NCT03219632
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Assess the efficacy of fimasartan on left ventricular hypertrophy in hypertensive patients

Detailed Description

Patients who were diagnosed with left ventricular hypertrophy (LVH) by ECG at the start of the study are followed up at 3-month intervals for 1 year.

Increase Fimasartan if blood pressure is not controlled.

Study Timeline

• Study Start: 2012-06-05
• Primary Completion: 2017-04-30
• Study Completion: 2017-05-30
• Status Verified: 2017-07
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-14
• Last Update Submitted: 2017-07-14
• Study First Posted: 2017-07-17
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patients who have been treated or not treated with hypertension from 20 to 80 years of age

• Patients with electrocardiographic left ventricular hypertrophy (In this study, we define left ventricular hypertrophy if one of the following two criteria is met)

  1. RaVL+SV3 > 20mm(M). 16mm(F)
  2. SV1+RV5 or RV6 > 35mm.

• Patients who are taking or expecting Fimasartan

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Exclusion Criteria

• Patients with unstable angina or myocardial infarction within 3 months
• Patients with clinically significant severe valve disease, congenital heart disease, peripheral vascular disease, cerebrovascular disease
• Clinically significant severe congestive heart failure patients
• Patients with renal dialysis
• Clinically significant renal disease patients
• Patients with clinically significant hepatic impairment
• Patients with a history of alcohol or substance abuse
• Patients with hypersensitivity to angiotensin-receptor blocker
• Patients needing angiotensin-receptor blocker drugs other than fimasartan
• For women, pregnancy, Patients who are breastfeeding or planning to become pregnant
• A person who is determined to be inappropriate by the Investigator
• Patients participating in other clinical trials

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG (composite).	1 year	Measurements of changes in baseline at 12 months (change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG)