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A Randomized Trial of Angiotensin Receptor bLocker,Fimasartan, in Aortic Stenosis (ALFA Trial) (ALFA)

Primary Purpose

Critical Stenosis of Aortic Valve

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Stenosis of Aortic Valve focused on measuring Aortic stenosis, Exercise performance, cardiopulmonary exercise test, fimasartan

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting
  • Chonnam University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Samsung Medical Center, Sungkyunkwan University School of MedicineRecruiting
  • Korea University Anam HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Yonsei University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Arm

Fimasartan

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
Change of mean pressure gradient across aortic valve
Change of mean pressure gradient which will be measured in echocardiography from baseline to study end.
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
Left ventricular mass index (LVMI)
Change of LVMI from baseline to study end.
Development of aortic stenosis symptoms
Development of aortic stenosis symptoms angina, dyspnea, or syncope
Admission for heart failure
During 1 year follow-up, admission due to congestiv eheart failure will be evaluated as secondary clinical outcome.
Development of left ventricular dysfunction (LVEF <50%)
During follow-up, the development of LV dysfunction in echocardiography will be evaluated.
Aortic valve surgery
During 1 year follow-up, the incidence of aortic valver surgery will be evaluated.
Cardiac death including Sudden cardiac death
Cardiac death
All-cause death
All-cause mortality
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
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)
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.

Full Information

First Posted
April 29, 2012
Last Updated
April 30, 2012
Sponsor
Seoul National University Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT01589380
Brief Title
A Randomized Trial of Angiotensin Receptor bLocker,Fimasartan, in Aortic Stenosis (ALFA Trial)
Acronym
ALFA
Official Title
Safety and Efficacy of Angiotensin Receptor Blocker, Fimasartan, on Patients With Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Stenosis of Aortic Valve
Keywords
Aortic stenosis, Exercise performance, cardiopulmonary exercise test, fimasartan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Fimasartan
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fimasartan
Other Intervention Name(s)
Fimasartan (BR-A-657; CAS : 247257-48-3; Kanarb)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lactose Hydrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of VmaxO2 in Cardiopulmonary Exercise Test
Description
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)
Time Frame
Baseline and 1 year
Secondary Outcome Measure Information:
Title
Change of peak aortic jet velocity in echocardiography
Description
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.
Time Frame
Baseline and 1 year
Title
Change of mean pressure gradient across aortic valve
Description
Change of mean pressure gradient which will be measured in echocardiography from baseline to study end.
Time Frame
Baseline and 1 year
Title
Diastolic function - LA area (cm2), E/E' value
Description
Change of LA area (cm2), E/E' value measured with Doppler echocardiography from baseline to study end
Time Frame
Baseline and 1 year
Title
Left ventricular mass index (LVMI)
Description
Change of LVMI from baseline to study end.
Time Frame
Baseline and 1 year
Title
Development of aortic stenosis symptoms
Description
Development of aortic stenosis symptoms angina, dyspnea, or syncope
Time Frame
Baseline and 1 year
Title
Admission for heart failure
Description
During 1 year follow-up, admission due to congestiv eheart failure will be evaluated as secondary clinical outcome.
Time Frame
Baseline and 1 year
Title
Development of left ventricular dysfunction (LVEF <50%)
Description
During follow-up, the development of LV dysfunction in echocardiography will be evaluated.
Time Frame
Baseline and 1 year
Title
Aortic valve surgery
Description
During 1 year follow-up, the incidence of aortic valver surgery will be evaluated.
Time Frame
Baseline and 1 year
Title
Cardiac death including Sudden cardiac death
Description
Cardiac death
Time Frame
Baseline and 1 year
Title
All-cause death
Description
All-cause mortality
Time Frame
Baseline and 1 year
Title
Composite Clinical Endpoint
Description
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
Time Frame
Baseline and 1 year
Title
6-minutes walk distance
Description
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)
Time Frame
Baseline and 1 year
Title
Safety Endpoint
Description
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.
Time Frame
Baseline and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-Jin Kim, MD, PhD
Phone
82-010-3782-9382
Email
kimdamas@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Joo Myung Lee, MD
Phone
82-011-9884-8439
Email
drone80@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Jin Kim, MD,PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Seung-Pyo Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sung-Ji Park, MD,PhD
Organizational Affiliation
Samsung Medical Center, Sungkyunkwan University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Goo-Yeong Cho, MD,PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyung-Kwan Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seong-Mi Park
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seong Woo Han
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kye Hun Kim
Organizational Affiliation
Chonnam University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geu-Ru Hong
Organizational Affiliation
Yonsei University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goo-Yeong Cho
Email
cardioch@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Goo-Yeong Cho, MD,PhD
Facility Name
Chonnam University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kye Hun Kim, MD,PhD
Email
christiankyehun@hanmail.net
First Name & Middle Initial & Last Name & Degree
Kye Hun Kim, MD,PhD
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Jin Kim, MD,PhD
Phone
82-10-3782-9382
Email
kimdamas@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD
Phone
82-11-9884-8439
Email
drone80@hanmail.net
First Name & Middle Initial & Last Name & Degree
Yong-Jin Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hyung-Kwan Kim, MD,PhD
First Name & Middle Initial & Last Name & Degree
Seung-Pyo Lee, MD
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD
Facility Name
Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Ji Park, MD,PhD
Email
tyche.park@gmail.com
First Name & Middle Initial & Last Name & Degree
Sung-Ji Park, MD,PhD
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong-Mi Park, MD,PhD
Email
smparkmd@korea.ac.kr
First Name & Middle Initial & Last Name & Degree
Seong-Mi Park, MD,PhD
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Woo Han, MD,PhD
Email
hansw29@gmail.com
First Name & Middle Initial & Last Name & Degree
Seong Woo Han, MD,PhD
Facility Name
Yonsei University Hospital
City
Seoul
ZIP/Postal Code
705-717
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geu-Ru Hong, MD,PhD
Email
grhong@ynu.ac.kr
First Name & Middle Initial & Last Name & Degree
Geu-Ru Hong, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

A Randomized Trial of Angiotensin Receptor bLocker,Fimasartan, in Aortic Stenosis (ALFA Trial)

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