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

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



Sponsors


Source

Seoul National University Bundang Hospital

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

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

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.

Overall Status

Completed

Start Date

2012-06-05

Completion Date

2017-05-30

Primary Completion Date

2017-04-30

Phase

N/A

Study Type

Observational [Patient Registry]

Primary Outcome

Measure

Time Frame

The change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG (composite).
1 year

Number Of Groups

1

Enrollment

72

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

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


Eligibility

Study Pop

Registered 319 people considering 30% dropout rate

Sampling Method

Non-Probability Sample

Criteria

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

Gender

All

Minimum Age

20 Years

Maximum Age

80 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Dong-Ju choi
Principal Investigator
Seoul National University Bundang Hospital

Verification Date

2017-07-01

Lastchanged Date

2017-07-14

Firstreceived Date

2017-07-12

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Seoul National University Bundang Hospital

Investigator Full Name

Dong-Ju Choi

Investigator Title

Professor, MD, PhD


Has Expanded Access

No

Condition Browse


Firstreceived Results Date

N/A

Reference

Citation

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

PMID

11231428


Citation

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


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.

PMID

8348686


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.

PMID

12885747



Target Duration

1 Year

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Case-Control

Time Perspective

Prospective



ClinicalTrials.gov processed this data on July 17, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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