Angiotensin Receptor Blocker After TAVR in Severe Aortic Stenosis With Left Ventricular Hypertrophy (ARBITAR)

Angiotensin Receptor Blockade In patients after Transcatheter Aortic valve Replacement for severe aortic stenosis with left ventricular hypertrophy (ARBITAR) trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0012112

Enrollment

632

Registered

2026-06-11

Start date

2026-06-15

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : An oral angiotensin receptor blocker — candesartan, losartan, or valsartan — is administered to the experimental group and, as a principle, up-titrated toward the target daily dose, with initia

losartan 25–50 mg once daily titrated to 50–150 mg once daily

valsartan 20–40 mg once daily titrated to 160 mg twice daily. Treatment is continued for up to 24 months. The control(No ARB) group is not administered any ARB drugs, including oral angiotensin recept

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female aged 40 years or older 2. Symptomatic severe aortic stenosis (AS) with left ventricular hypertrophy (LVH) who successfully underwent transcatheter aortic valve replacement (TAVR) within the prior 30 days, including native-valve or valve-in-valve TAVR a) Severe AS defined by at least one of the following: aortic valve area =1.0 cm²; aortic valve area index =0.6 cm²/m²; mean pressure gradient =40 mmHg; or maximal aortic valve velocity =4.0 m/sec; LVH defined as left ventricular mass index >115 g/m² in men or >95 g/m² in women b) Successful TAVR (technical success) meeting all VARC-3 criteria: survival; successful access, delivery, and retrieval of the device; correct positioning of a single prosthetic valve in the proper anatomic location; no additional surgery or procedure related to the device (excluding permanent pacemaker implantation) or to major vascular, access-site, or cardiac structural complications; and intended prosthetic valve performance (mean gradient 40% after TAVR 4. Provided written informed consent to participate, either voluntarily or through a legal representative.

Exclusion criteria

Exclusion criteria: 1. Hypotension (systolic blood pressure 6.0 mmol/L) 3. Bilateral renal artery stenosis without stent placement 4. Allergy, hypersensitivity, or prior intolerance to angiotensin receptor blockers 5. Pregnancy, breastfeeding, or planning to become pregnant 6. Estimated life expectancy of less than 2 years 7. Acute coronary syndrome diagnosed within the past 1 year 8. Any other medical condition that, in the investigator's judgment, makes participation in the trial inappropriate

Design outcomes

Primary

Measure	Time frame
Composite of all-cause death or admission for heart failure	—

Secondary

Measure	Time frame
admission for heart failure;myocardial infarction;stroke (ischemic and/or hemorrhagic);redo aortic valve replacement (redo-AVR);Echocardiographic measurements;NT-proBNP;New York Heart Association (NYHA) functional class;Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score;all-cause death;cardiovascular death;any admission	—

Countries

Korea, Republic of

Contacts

Public ContactJung-Kyu Han

Seoul National University Hospital

hpcrates@gmail.com+82-2-2072-4870

Outcome results