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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219632
• Other study ID #: ACADEMY
• Status: Completed
• Phase: N/A
• First received: July 12, 2017
• Last updated: July 14, 2017
• Start date: June 5, 2012
• Est. completion date: May 30, 2017

Study information

• Verified date: July 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Hypertension
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

References & Publications (4)

Katholi RE, Couri DM. Left ventricular hypertrophy: major risk factor in patients with hypertension: update and practical clinical applications. Int J Hypertens. 2011;2011:495349. doi: 10.4061/2011/495349. Epub 2011 Jun 30. — View Citation

Okin PM, Devereux RB, Jern S, Kjeldsen SE, Julius S, Nieminen MS, Snapinn S, Harris KE, Aurup P, Edelman JM, Dahlof B; Losartan Intervention for Endpoint reduction in hypertension Study Investigations. Regression of electrocardiographic left ventricular hypertrophy by losartan versus atenolol: The Losartan Intervention for Endpoint reduction in Hypertension (LIFE) Study. Circulation. 2003 Aug 12;108(6):684-90. Epub 2003 Jul 28. — View Citation

Sadoshima J, Izumo S. Molecular characterization of angiotensin II--induced hypertrophy of cardiac myocytes and hyperplasia of cardiac fibroblasts. Critical role of the AT1 receptor subtype. Circ Res. 1993 Sep;73(3):413-23. — View Citation

Vakili BA, Okin PM, Devereux RB. Prognostic implications of left ventricular hypertrophy. Am Heart J. 2001 Mar;141(3):334-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG (composite).	Measurements of changes in baseline at 12 months (change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG)	1 year