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

NCT ID: NCT03219632

Last Updated: 2017-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-05

Study Completion Date

2017-05-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Left Ventricular Hypertrophy Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Fimasartan

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Ju Choi

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Ju choi

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

References

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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.

Reference Type BACKGROUND
PMID: 11231428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21755036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8348686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12885747 (View on PubMed)

Other Identifiers

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ACADEMY

Identifier Type: -

Identifier Source: org_study_id

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