Critical Stenosis of Aortic ValvePhase 4ALFANCT01589380
A Randomized Trial of Angiotensin Receptor bLocker,Fimasartan, in Aortic Stenosis (ALFA Trial)
A Phase 4 study testing Fimasartan in people with Critical Stenosis of Aortic Valve, run by Seoul National University Hospital at 7 sites in South Korea.
Trial summary
We hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse LV remodeling favorably in patients with asymptomatic moderate to severe AS. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Critical Stenosis of Aortic Valve
- What is being tested?
- Fimasartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Apr 2012to Dec 2014
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age: 20-75 years
- Moderate to severe aortic stenosis defined as a continuous wave Doppler determined peak aortic valve jet velocity of 3.0 - 4.5 m/s, mean pressure gradient of 25 - 49 mmHg, or aortic valve area of 0.76 - 1.5 cm2.
- Asymptomatic aortic stenosis patients, Stationary or minimum dyspnea on exertion (NYHA Fc ≤ I or II) will be included.
- Patients who were prescribed ACEI or ARBs for treatment of hypertension will be enrolled after 2 weeks wash-out period.
- SBP 120-140 mmHg with or without medication regardless of presence of hypertension or not.
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- Patients with BP > 140/90 mmHg with or without medication will be included after their BP is controlled with anti-hypertensive medication other than ACEI/ARBs.
- Patients who are able to perform appropriate cardiopulmonary exercise test with treadmill.
- The patient agrees to the study protocol and the schedule of clinical, cardiopulmonary exercise test, and echocardiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- Symptomatic aortic stenosis: presence of exertional dyspnea (≥ NYHA Fc III), angina or syncope
- Very severe aortic stenosis regardless of presence of symptoms. It was defined as a critical stenosis in the aortic valve area ≤ 0.75 cm2 accompanied by a peak aortic jet velocity ≥4.5 m/s or a mean transaortic pressure gradient ≥50 mm Hg on Doppler echocardiography.
- Uncontrolled HTN (SBP > 160 or DBP >100) without ACEI or ARBs during 2-weeks wash out period in patients who were prescribed ACEI or ARBs for treatment of hypertension.
- Patients with known history of coronary artery disease including myocardial infarction, regardless of the treatment (medication only, percutaneous coronary intervention, or coronary artery bypass grafting).
- Planned cardiac surgery or planned major non-cardiac surgery within the study period.
- Stroke or resuscitated sudden death in the past 6 months.
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- Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, or nasal corticosteroids is permissible).
- Untreated hyperthyroidism or hypothyroidism with TSH levels more than 2 times upper limit of normal.
- A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
- Female of child-bearing potential who do not use adequate contraception and women who are pregnant or breast-feeding.
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- Evidence of congestive heart failure, or left ventricular ejection fraction < 50%.
- Significant renal disease manifested by serum creatinine > 2.0mg/dL
- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- Documented bilateral renal artery stenosis or known contraindication of ACEI or ARBs
- History of chronic obstructive pulmonary disease or asthma manifested by acute aggravation of COPD in the past 6 months, or currently taking bronchodilators including long-acting beta2 agonist, anticholinergics, or inhaled steroids.
- Other valvular disease : Moderate or severe mitral regurgitation or mitral stenosis, Moderate or severe aortic regurgitation
- Patients who are unable to perform cardiopulmonary exercise test.
- Unwillingness or inability to comply with the procedures described in this protocol.
- Patient who have been diagnosed with galactose intolerance, lactase deficiency, malabsorption of glucose or galactose which is main ingredient of placebo.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites, 7 recruiting
- Recruiting
Chonnam University Hospital
Gwangju, Gwangju, 501-757
Kye Hun Kim, MD,PhD, christiankyehun@hanmail.net
Kye Hun Kim, MD,PhD
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Goo-Yeong Cho, cardioch@snu.ac.kr
Goo-Yeong Cho, MD,PhD
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 110-744
Yong-Jin Kim, MD,PhD, 82-10-3782-9382, kimdamas@snu.ac.kr
Joo Myung Lee, MD, 82-11-9884-8439, drone80@hanmail.net
- Recruiting
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Seoul, 135-710
Sung-Ji Park, MD,PhD, tyche.park@gmail.com
Sung-Ji Park, MD,PhD
- Recruiting
Korea University Anam Hospital
Seoul, Seoul, 136-705
Seong-Mi Park, MD,PhD, smparkmd@korea.ac.kr
Seong-Mi Park, MD,PhD
- Recruiting
Korea University Guro Hospital
Seoul, Seoul, 136-705
Seong Woo Han, MD,PhD, hansw29@gmail.com
Seong Woo Han, MD,PhD
- Recruiting
Yonsei University Hospital
Seoul, Seoul, 705-717
Geu-Ru Hong, MD,PhD, grhong@ynu.ac.kr
Geu-Ru Hong, MD,PhD
About this study
Official title: Safety and Efficacy of Angiotensin Receptor Blocker, Fimasartan, on Patients With Aortic Stenosis
We hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse LV remodeling favorably in patients with asymptomatic moderate to severe AS.
Read the detailed description
Aortic stenosis (AS) is common valvular disorder, affecting 2% to 4% of adults older than 65 years. It is gradually but constantly progressive disease whit a long asymptomatic phase, but once symptoms develop, the prognosis is poor.
Currently, treatment strategy is focused mainly to watchful monitoring and judicious timing of aortic valve replacement (AVR). However, not all patients are proper candidate of corrective surgery and the needs of development of medical treatment are increasing. Various mechanisms have been suggested in progression of AS and recent observational studies suggested not only mechanical stress of "wear and tear" but also active inflammatory process likewise atherosclerosis may contribute the progression of AS. Through clinical descriptive studies, atherosclerotic risk factors, such as hypertension, diabetes mellitus, dyslipidemia, obesity, smoking, and metabolic syndrome have been known to facilitate the progression of AS.
The renin-angiotensin system (RAS) is activated at an early stage of AS, promoting developemtnt of left ventricular hypertrophy (LVH), myocardial fibrosis, and diastolic dysfunction. Lipid lowering therapy and RAS blockade have emerged potential medical treatment to slow the progression of AS, however, many clinical trials did not show consistent beneficial effect of statins.8-10 RAS blockers are perceived as being relative contraindication due to concerns about increasing pressure gradient. However, patients with AS tolerate RAS blocker well on initiation and the use of angiotensin converting enzyme (ACE) inhibitors appears to confer long term survival benefit on patients considered to have a contraindication including AS.Pressure overload of LV, activation of RAS, and subsequent adverse LV remodeling, myocardial fibrosis, and LV dysfunction may potential therapeutic target to retard the progression of AS and to improve exercise capacity, and even long-term outcomes. RAS blocker including ACEI or angiotensin receptor blockers (ARBs) have been known to improve exercise capacity and long term outcome in patient with hypertension, congestive heart failure, or myocardial infarction.
We hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse LV remodeling favorably in patients with asymptomatic moderate to severe AS.
Prospective, double-blinded, randomized clinical trial with enrollment of normotensive or hypertensive patients of age 20 to 75 who require echocardiography for a clinical indication, which typically consists of known aortic stenosis or presence of cardiac murmur. Moderate to severe aortic stenosis will be defined as a continuous wave Doppler determined peak aortic valve jet velocity of 3.0 - 4.5 m/s or mean pressure gradient of 25 - 49 mmHg, or aortic valve area of 0.76 - 1.5 cm2. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 to angiotensin receptor blocker, Fimasartan, or placebo. After 1-year enrollment period, all patients will be followed for 1 year. Cardiopulmonary exercise test will be performed at baseline enrollment period, and at the end of follow-up. Echocardiographic evaluation will be performed at regular interval of baseline and 6 months interval until the end of study.
- Conditions
- Critical Stenosis of Aortic Valve
- Being tested
- Fimasartan, Placebo
- Keywords
- Aortic stenosis, Exercise performance, cardiopulmonary exercise test, fimasartan
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
Also called Fimasartan (BR-A-657; CAS : 247257-48-3; Kanarb)
Fimasartan, Initial dose will be started with 30mg per day. At 12 months follow-up after the enrollment, dose titration up to 60 mg per day will be made with target blood pressure of 120/80.
Dose escalization from 30mg/day to 60mg/day will be performed in the case of follow-up systolic blood pressure is over 120. If the follow-up systolic blood pressure is less than 120, initial dose of 30mg/day will be maintained throughout the study duration. If hypotension (BP < 90/60) is developed, the study medication will be discontinued and the patient will be included safety outcome analysis and intention to treat analysis. Per protocol analysis will be also performed. The dose of placebo will be adjusted identically, according to the blood pressure criteria of fimasartan.
PlaceboDrug
Also called Lactose Hydrate
Placebo was used in phase 3 clinical trial of fimasartan (NCT00922480, NCT01135212, and NCT01258673). The same placebo, which is manufactures at Boryoung pharmaceutical company, will be used in this trial. After enrollment and randomization, placebo will be administered one capsule once daily in placebo group.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Placebo: Capsule that is containing lactate hydrate, identically appearing with fimasartan will be administered to patient in placebo group, once daily. Same placebo drug which was used in phase 3 clinical trial of fimasartan will be provided by Boryoung Phamaceutical company. Dose titration will be done with same criteria of fimasartan group. 30mg form and 60 mg form of placebo will be identical in its morphology. Receives: Drug: Placebo |
| Fimasartan | Active comparator | Fimasartan, Initial dose will be started with 30mg per day. At 12 months follow-up after the enrollment, dose titration up to 60 mg per day will be made with target blood pressure of 120/80.
Dose escalization from 30mg/day to 60mg/day will be performed in the case of follow-up systolic blood pressure is over 120. If the follow-up systolic blood pressure is less than 120, initial dose of 30mg/day will be maintained throughout the study duration. If hypotension (BP < 90/60) is developed, the study medication will be discontinued and the patient will be included safety outcome analysis and intention to treat analysis. Per protocol analysis will be also performed. The dose of placebo will be adjusted identically, according to the blood pressure criteria of fimasartan. Receives: Drug: Fimasartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of VmaxO2 in Cardiopulmonary Exercise Test
Change of VmaxO2 from baseline to 1 year follow-up. VmaxO2 is defined as the highest oxygen uptake, averaged over 5 consecutive breaths, during the last minute of symptom-limited cardiopulmonary exercise test. For each patient, the change in VamxO2 is calculated as (VmaxO2 at 1 year follow-up) - (VmaxO2 at baseline)
Measured: Baseline and 1 year
Secondary outcomes (13)
Change of peak aortic jet velocity in echocardiography
Change of peak aortic jet velocity which defined as (peak aortic jet velocity at 1 year follow-up) - (peak aortic jet velocity at baseline) on Doppler echocardiography.
Measured: Baseline and 1 year
Change of mean pressure gradient across aortic valve
Change of mean pressure gradient which will be measured in echocardiography from baseline to study end.
Measured: Baseline and 1 year
Diastolic function - LA area (cm2), E/E' value
Change of LA area (cm2), E/E' value measured with Doppler echocardiography from baseline to study end
Measured: Baseline and 1 year
Left ventricular mass index (LVMI)
Change of LVMI from baseline to study end.
Measured: Baseline and 1 year
Development of aortic stenosis symptoms
Development of aortic stenosis symptoms angina, dyspnea, or syncope
Measured: Baseline and 1 year
Admission for heart failure
During 1 year follow-up, admission due to congestiv eheart failure will be evaluated as secondary clinical outcome.
Measured: Baseline and 1 year
Development of left ventricular dysfunction (LVEF <50%)
During follow-up, the development of LV dysfunction in echocardiography will be evaluated.
Measured: Baseline and 1 year
Aortic valve surgery
During 1 year follow-up, the incidence of aortic valver surgery will be evaluated.
Measured: Baseline and 1 year
Cardiac death including Sudden cardiac death
Cardiac death
Measured: Baseline and 1 year
All-cause death
All-cause mortality
Measured: Baseline and 1 year
Composite Clinical Endpoint
Composite Endpoint which is consist of following:
Development of symptom of aortic stenosis: angina, dyspnea, or syncope Admission for heart failure Development of left ventricular dysfunction (LVEF <50%) Aortic valve surgery Cardiac death including Sudden cardiac death (will be collected separately) All-cause death Individual components of composite endpoint will be investigated separately also
Measured: Baseline and 1 year
6-minutes walk distance
6-minutes walk distance from baseline to 1 year follow-up. For each patient, the change in 6-minutes walk distance is calculated as (6-minutes walk distance at 1 year follow-up) - (6-minutes walk distance at baseline)
Measured: Baseline and 1 year
Safety Endpoint
- Development of symptomatic hypotension (dizziness, orthostatic hypotension with BP < 90/60)
- Development of overt azotemia (serum creatinine > 2.0mg/dL)
- Intolerance or development of other adverse drug reactions related with study drug.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Stenosis of Aortic ValveStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd, Seoul National University Bundang Hospital, Severance Hospital, Korea University Anam Hospital, Korea University Guro Hospital, Chonnam National University Hospital, Samsung Medical Center
- Responsible party
- Principal investigator, Yong-Jin Kim, Seoul National University Hospital
- Investigators
- Yong-Jin Kim, MD,PhD, Study chair, Seoul National University HospitalSeung-Pyo Lee, MD, Study director, Seoul National University HospitalJoo Myung Lee, MD, Study director, Seoul National University HospitalSung-Ji Park, MD,PhD, Principal investigator, Samsung Medical CenterGoo-Yeong Cho, MD,PhD, Principal investigator, Seoul National University Bundang HospitalHyung-Kwan Kim, MD, PhD, Study director, Seoul National University HospitalSeong-Mi Park, Principal investigator, Korea University Anam HospitalSeong Woo Han, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589380
- Sponsor's protocol ID
- NCT16453143
- Acronym
- ALFA
- Status last verified
- Apr 2012
- First submitted
- 29 Apr 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Angiotensin Receptor Blocker, Fimasartan, on Patients With Aortic Stenosis
- ClinicalTrials.gov ID
- NCT01589380
- Acronym / sponsor ID
- ALFA / NCT16453143
- Conditions
- Critical Stenosis of Aortic Valve
- Keywords
- Aortic stenosis, Exercise performance, cardiopulmonary exercise test, fimasartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd, Seoul National University Bundang Hospital, Severance Hospital, Korea University Anam Hospital, Korea University Guro Hospital, Chonnam National University Hospital, Samsung Medical Center
- Study start
- Apr 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 May 2012 (estimated)
- 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.
We hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse LV remodeling favorably in patients with asymptomatic moderate to severe AS.
Detailed description
Aortic stenosis (AS) is common valvular disorder, affecting 2% to 4% of adults older than 65 years. It is gradually but constantly progressive disease whit a long asymptomatic phase, but once symptoms develop, the prognosis is poor.
Currently, treatment strategy is focused mainly to watchful monitoring and judicious timing of aortic valve replacement (AVR). However, not all patients are proper candidate of corrective surgery and the needs of development of medical treatment are increasing. Various mechanisms have been suggested in progression of AS and recent observational studies suggested not only mechanical stress of "wear and tear" but also active inflammatory process likewise atherosclerosis may contribute the progression of AS. Through clinical descriptive studies, atherosclerotic risk factors, such as hypertension, diabetes mellitus, dyslipidemia, obesity, smoking, and metabolic syndrome have been known to facilitate the progression of AS.
The renin-angiotensin system (RAS) is activated at an early stage of AS, promoting developemtnt of left ventricular hypertrophy (LVH), myocardial fibrosis, and diastolic dysfunction. Lipid lowering therapy and RAS blockade have emerged potential medical treatment to slow the progression of AS, however, many clinical trials did not show consistent beneficial effect of statins.8-10 RAS blockers are perceived as being relative contraindication due to concerns about increasing pressure gradient. However, patients with AS tolerate RAS blocker well on initiation and the use of angiotensin converting enzyme (ACE) inhibitors appears to confer long term survival benefit on patients considered to have a contraindication including AS.Pressure overload of LV, activation of RAS, and subsequent adverse LV remodeling, myocardial fibrosis, and LV dysfunction may potential therapeutic target to retard the progression of AS and to improve exercise capacity, and even long-term outcomes. RAS blocker including ACEI or angiotensin receptor blockers (ARBs) have been known to improve exercise capacity and long term outcome in patient with hypertension, congestive heart failure, or myocardial infarction.
We hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse LV remodeling favorably in patients with asymptomatic moderate to severe AS.
Prospective, double-blinded, randomized clinical trial with enrollment of normotensive or hypertensive patients of age 20 to 75 who require echocardiography for a clinical indication, which typically consists of known aortic stenosis or presence of cardiac murmur. Moderate to severe aortic stenosis will be defined as a continuous wave Doppler determined peak aortic valve jet velocity of 3.0 - 4.5 m/s or mean pressure gradient of 25 - 49 mmHg, or aortic valve area of 0.76 - 1.5 cm2. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 to angiotensin receptor blocker, Fimasartan, or placebo. After 1-year enrollment period, all patients will be followed for 1 year. Cardiopulmonary exercise test will be performed at baseline enrollment period, and at the end of follow-up. Echocardiographic evaluation will be performed at regular interval of baseline and 6 months interval until the end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo: Capsule that is containing lactate hydrate, identically appearing with fimasartan will be administered to patient in placebo group, once daily. Same placebo drug which was used in phase 3 clinical trial of fimasartan will be provided by Boryoung Phamaceutical company. Dose titration will be done with same criteria of fimasartan group. 30mg form and 60 mg form of placebo will be identical in its morphology. |
| Fimasartan | Active comparator | Drug: FimasartanFimasartan, Initial dose will be started with 30mg per day. At 12 months follow-up after the enrollment, dose titration up to 60 mg per day will be made with target blood pressure of 120/80. Dose escalization from 30mg/day to 60mg/day will be performed in the case of follow-up systolic blood pressure is over 120. If the follow-up systolic blood pressure is less than 120, initial dose of 30mg/day will be maintained throughout the study duration. If hypotension (BP < 90/60) is developed, the study medication will be discontinued and the patient will be included safety outcome analysis and intention to treat analysis. Per protocol analysis will be also performed. The dose of placebo will be adjusted identically, according to the blood pressure criteria of fimasartan. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female
- Age: 20-75 years
- Moderate to severe aortic stenosis defined as a continuous wave Doppler determined peak aortic valve jet velocity of 3.0 - 4.5 m/s, mean pressure gradient of 25 - 49 mmHg, or aortic valve area of 0.76 - 1.5 cm2.
- Asymptomatic aortic stenosis patients, Stationary or minimum dyspnea on exertion (NYHA Fc ≤ I or II) will be included.
- Patients who were prescribed ACEI or ARBs for treatment of hypertension will be enrolled after 2 weeks wash-out period.
Key exclusion criteria (20 listed)
- Symptomatic aortic stenosis: presence of exertional dyspnea (≥ NYHA Fc III), angina or syncope
- Very severe aortic stenosis regardless of presence of symptoms. It was defined as a critical stenosis in the aortic valve area ≤ 0.75 cm2 accompanied by a peak aortic jet velocity ≥4.5 m/s or a mean transaortic pressure gradient ≥50 mm Hg on Doppler echocardiography.
- Uncontrolled HTN (SBP > 160 or DBP >100) without ACEI or ARBs during 2-weeks wash out period in patients who were prescribed ACEI or ARBs for treatment of hypertension.
- Patients with known history of coronary artery disease including myocardial infarction, regardless of the treatment (medication only, percutaneous coronary intervention, or coronary artery bypass grafting).
- Planned cardiac surgery or planned major non-cardiac surgery within the study period.
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 |
|---|---|---|
| FimasartanAlso: Fimasartan (BR-A-657; CAS : 247257-48-3; Kanarb)Fimasartan, Initial dose will be started with 30mg per day. At 12 months follow-up after the enrollment, dose titration up to 60 mg per day will be made with target blood pressure of 120/80. Dose escalization from 30mg/day to 60mg/day will be performed in the case of follow-up systolic blood pressure is over 120. If the follow-up systolic blood pressure is less than 120, initial dose of 30mg/day will be maintained throughout the study duration. If hypotension (BP < 90/60) is developed, the study medication will be discontinued and the patient will be included safety outcome analysis and intention to treat analysis. Per protocol analysis will be also performed. The dose of placebo will be adjusted identically, according to the blood pressure criteria of fimasartan. | Drug | Fimasartan |
| PlaceboAlso: Lactose HydratePlacebo was used in phase 3 clinical trial of fimasartan (NCT00922480, NCT01135212, and NCT01258673). The same placebo, which is manufactures at Boryoung pharmaceutical company, will be used in this trial. After enrollment and randomization, placebo will be administered one capsule once daily in placebo group. | Drug | Placebo Arm |
Primary outcome
Change of VmaxO2 in Cardiopulmonary Exercise Test
Time frame: Baseline and 1 year
Change of VmaxO2 from baseline to 1 year follow-up. VmaxO2 is defined as the highest oxygen uptake, averaged over 5 consecutive breaths, during the last minute of symptom-limited cardiopulmonary exercise test. For each patient, the change in VamxO2 is calculated as (VmaxO2 at 1 year follow-up) - (VmaxO2 at baseline)
13 secondary outcomes
Change of peak aortic jet velocity in echocardiography
Time frame: Baseline and 1 year
Change of mean pressure gradient across aortic valve
Time frame: Baseline and 1 year
Diastolic function - LA area (cm2), E/E' value
Time frame: Baseline and 1 year
Left ventricular mass index (LVMI)
Time frame: Baseline and 1 year
Development of aortic stenosis symptoms
Time frame: Baseline and 1 year
Admission for heart failure
Time frame: Baseline and 1 year
Development of left ventricular dysfunction (LVEF <50%)
Time frame: Baseline and 1 year
Aortic valve surgery
Time frame: Baseline and 1 year
Cardiac death including Sudden cardiac death
Time frame: Baseline and 1 year
All-cause death
Time frame: Baseline and 1 year
Composite Clinical Endpoint
Time frame: Baseline and 1 year
6-minutes walk distance
Time frame: Baseline and 1 year
Safety Endpoint
Time frame: Baseline and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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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.
Yong-Jin Kim, MD,PhD study chair
Seoul National University Hospital
Seung-Pyo Lee, MD study director
Seoul National University Hospital
Joo Myung Lee, MD study director
Seoul National University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fimasartan in people with Critical Stenosis of Aortic Valve, run by Seoul National University Hospital at 7 sites in South Korea.
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 9 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong-Jin Kim, MD, PhD (82-010-3782-9382, kimdamas@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of VmaxO2 in Cardiopulmonary Exercise Test (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2012.