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Completed

NCT Number: NCT03219632

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

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

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Key information

Conditions

Left Ventricular Hypertrophy Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertension Hypertrophy Hypertrophy, Left Ventricular Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • RaVL+SV3 > 20mm(M). 16mm(F)
  • 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

Treatment and study plan

Fimasartan

Drug

Fimasartan is a non-peptide angiotensin II receptor antagonist (ARB) used for the treatment of hypertension and heart failure.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2017
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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