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

Conditions

• Critical Stenosis of Aortic Valve

Interventions

DRUG

Fimasartan

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

Placebo

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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd

  collaborator INDUSTRY

• Seoul National University Bundang Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Yong-Jin Kim, MD,PhD · Seoul National University Hospital

• Seung-Pyo Lee, MD · Seoul National University Hospital

• Joo Myung Lee, MD · Seoul National University Hospital

• Sung-Ji Park, MD,PhD · Samsung Medical Center, Sungkyunkwan University School of Medicine

• Goo-Yeong Cho, MD,PhD · Seoul National University Bundang Hospital

• Hyung-Kwan Kim, MD, PhD · Seoul National University Hospital

• Seong-Mi Park · Korea University Anam Hospital

• Seong Woo Han · Korea University Guro Hospital

• Kye Hun Kim · Chonnam University Hospital

• Geu-Ru Hong · Yonsei University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2013-05-31

Completion

2014-12-31

Countries

• South Korea

Study Locations