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

NCT03219632 | Completed DMC

• 1 other identifier: ACADEMY
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Left Ventricular Hypertrophy; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Fimasartan DRUG

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Registered 319 people considering 30% dropout rate

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Related Publications (4)

• Vakili BA, Okin PM, Devereux RB. Prognostic implications of left ventricular hypertrophy. Am Heart J. 2001 Mar;141(3):334-41. doi: 10.1067/mhj.2001.113218.

  PMID: 11231428 BACKGROUND

• 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.

  PMID: 21755036 BACKGROUND

• 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. doi: 10.1161/01.res.73.3.413.

  PMID: 8348686 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000083724.28630.C3. Epub 2003 Jul 28.

  PMID: 12885747 BACKGROUND

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Hypertension

Interventions

fimasartan

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Dong-Ju choi

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 17, 2017
• Study Start: June 5, 2012
• Primary Completion: April 30, 2017
• Study Completion: May 30, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share