Clinical trial NCT03219632: Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG
Official title: Angiotensin Blocking Effect of Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG: a Prospective, Multicenter, Observational Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Hypertrophy
Hypertension
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registered 319 people considering 30% dropout rate

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.

Eligibility 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

Primary outcomes:
measure: The change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG (composite).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Dong-Ju choi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1161/01.res.73.3.413.
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. doi: 10.1161/01.CIR.0000083724.28630.C3. Epub 2003 Jul 28.