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

July 14, 2017 updated by: Dong-Ju Choi, Seoul National University Bundang Hospital

Angiotensin Blocking Effect of Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG: a Prospective, Multicenter, Observational Registry

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

72

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Registered 319 people considering 30% dropout rate

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG (composite).
Time Frame: 1 year
Measurements of changes in baseline at 12 months (change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2012

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (Actual)

July 17, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACADEMY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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