Left Ventricular HypertrophyNCT03219632
Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG
An observational study of Left Ventricular Hypertrophy and Hypertension, run by Seoul National University Bundang Hospital.
Trial summary
Assess the efficacy of fimasartan on left ventricular hypertrophy in hypertensive patients Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Left Ventricular Hypertrophy, Hypertension
- What is being tested?
- Fimasartan
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2012to 30 May 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Registered 319 people considering 30% dropout rate
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
Official title: Angiotensin Blocking Effect of Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG: a Prospective, Multicenter, Observational Registry
Assess the efficacy of fimasartan on left ventricular hypertrophy in hypertensive patients
Read the 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.
- Conditions
- Left Ventricular Hypertrophy, Hypertension
- Being tested
- Fimasartan
- Medical subject headings
- Hypertrophy, Left Ventricular, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
Fimasartan is a non-peptide angiotensin II receptor antagonist (ARB) used for the treatment of hypertension and heart failure.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start5 Jun 2012
- Primary completion30 Apr 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular HypertrophyStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Ju Choi, Seoul National University Bundang Hospital
- Investigators
- Dong-Ju choi, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219632
- Sponsor's protocol ID
- ACADEMY
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2017
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11231428Katholi 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.
PubMed 21755036Sadoshima 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.
PubMed 8348686Okin 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.
PubMed 12885747
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin Blocking Effect of Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG: a Prospective, Multicenter, Observational Registry
- ClinicalTrials.gov ID
- NCT03219632
- Acronym / sponsor ID
- ACADEMY
- Conditions
- Left Ventricular Hypertrophy, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 5 Jun 2012 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Registered 319 people considering 30% dropout rate
Key inclusion criteria (5 listed)
- 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)
- Patients who are taking or expecting Fimasartan
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FimasartanFimasartan is a non-peptide angiotensin II receptor antagonist (ARB) used for the treatment of hypertension and heart failure. | Drug | – |
Primary outcome
The change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG (composite).
Time frame: 1 year
Measurements of changes in baseline at 12 months (change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Background: PubMed 11231428Vakili 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.
- Background: PubMed 21755036Katholi 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.
- Background: PubMed 8348686Sadoshima 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.
- Background: PubMed 12885747Okin 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.
- Individual participant dataSharing planned: No
Related trials for Left Ventricular Hypertrophy
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruiting
Therapeutic Implications of CMR Low Native T1 in Non-treated Non-hypertrophic Females With Fabry Disease (FD)
Fabry Disease
RecruitingPhase 2
A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
Danon Disease
Active, not recruiting
Sodium Lowering Vascular Effects Trial
Endothelial Dysfunction, Vascular Stiffness
RecruitingObservational study
Can Exercise Electrocardiography Discriminate Hypertensive Heart Disease From Obstructive Coronary Artery Disease? A Multimodality Imaging Study
Obstructive Coronary Artery Disease, Left Ventricular Hypertrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Ju choi principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Hypertrophy and Hypertension, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in systolic and diastolic blood pressure, left ventricular hypertrophy in ECG (composite). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219632, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.