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Transcatheter Aortic Valve Replacement (TAVR)Phase 4ARBITARNCT07735130

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

A Phase 4 study testing Angiotensin Receptor Blocker (ARB) in people with Transcatheter Aortic Valve Replacement (TAVR) and Left Ventricular Hypertrophy, run by Seoul National University Hospital at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, prospective, open-label, randomized, investigator-initiated trial evaluating whether angiotensin receptor blocker (ARB) therapy improves clinical outcomes in patients with severe aortic stenosis (AS) and left ventricular hypertrophy (LVH) who have undergone transcatheter aortic valve replacement… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Angiotensin Receptor Blocker (ARB)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
632 participants
Where
1 siteSouth Korea
Study dates
15 Aug 2026to 15 Jun 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged 40 years or older
  • 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
  • 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
  • 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 <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)
  • Left ventricular ejection fraction (LVEF) >40% before TAVR
  • Provided written informed consent to participate, either voluntarily or through a legal representative

Who cannot join

  • Hypotension (systolic blood pressure <90 mmHg) or hemodynamic instability defined as a need for continuous intravenous vasopressor support at screening
  • Hyperkalemia (serum potassium >5.5 mmol/L)
  • Bilateral renal artery stenosis without stent placement
  • Allergy, hypersensitivity, or prior intolerance to angiotensin receptor blockers
  • Pregnancy, breastfeeding, or planning to become pregnant
  • Estimated life expectancy of less than 2 years
Show all 9Show fewer
  • Acute coronary syndrome diagnosed within the past 1 year
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 by the CKD-EPI equation, or currently undergoing renal replacement therapy
  • Any other medical condition that, in the investigator's judgment, makes participation in the trial inappropriate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jung-Kyu Han, MD, PhD contact

+82-2-2072-4870

hpcrates@gmail.com

South Korea1 site

  • Seoul National University Hospital

    Seoul, Seoul, 03080

    Jung-Kyu Han, MD, PhD, +82-2-2072-4870, hpcrates@gmail.com

Other trials in South Korea

About this study

Official title: Angiotensin Receptor Blockade In Patients After Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis With Left Ventricular Hypertrophy (ARBITAR) Trial

This is a multicenter, prospective, open-label, randomized, investigator-initiated trial evaluating whether angiotensin receptor blocker (ARB) therapy improves clinical outcomes in patients with severe aortic stenosis (AS) and left ventricular hypertrophy (LVH) who have undergone transcatheter aortic valve replacement (TAVR).

Severe AS imposes chronic pressure overload on the left ventricle, leading to LVH as a compensatory response. While initially adaptive, sustained LVH promotes myocardial fibrosis, reduced ventricular compliance, and impaired cardiac function. LVH that persists after valve replacement is associated with increased morbidity and mortality, including a higher risk of heart failure. Blockade of the renin-angiotensin system (RAS) with angiotensin-converting enzyme inhibitors (ACEi) or ARBs has been proposed as a strategy to attenuate adverse left ventricular remodeling after valve replacement by inhibiting angiotensin II-mediated hypertrophic and fibrotic signaling. However, evidence in TAVR patients with LVH remains limited, and a small randomized trial of an ACEi reported drug discontinuation in approximately 10% of patients due to dry cough. The ARBITAR trial therefore evaluates the clinical efficacy of an ARB in this population.

Read more

A total of 632 patients with symptomatic severe AS and LVH who have successfully undergone TAVR within the prior 30 days will be randomized 1:1 to receive an ARB (experimental group) or no ARB (control group), stratified by site and sex. Assigned treatment is continued for up to 24 months, with follow-up visits at 1, 6, 12, and 24 months. In the experimental group, the ARB (candesartan, losartan, or valsartan) is up-titrated toward a target dose. ACE inhibitors, direct renin inhibitors, and angiotensin receptor/neprilysin inhibitors are prohibited in both groups.

The primary endpoint is the composite of all-cause death or admission for heart failure over 2 years. Secondary endpoints include the individual components of the primary endpoint and other clinical events, as well as echocardiographic measures, NT-proBNP, NYHA functional class, and KCCQ-12 score. The primary analysis follows the intention-to-treat principle.

Read the detailed description

Background and Rationale Severe aortic stenosis (AS) imposes chronic pressure overload on the left ventricle. To compensate for the elevated afterload, the left ventricular myocardium thickens, producing left ventricular hypertrophy (LVH). Although LVH initially serves as an adaptive mechanism in early AS, when it persists over the long term it leads to myocardial fibrosis, reduced left ventricular compliance, and deterioration of cardiac function.

Patients with severe AS and concomitant LVH generally have a poor prognosis even after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). LVH that persists after the procedure, and the resulting myocardial fibrosis, are closely associated with increased morbidity and mortality, including an increased risk of heart failure.

Blockade of the renin-angiotensin system (RAS), using ACE inhibitors (ACEi) or angiotensin receptor blockers (ARBs), has been proposed as a treatment strategy from which patients with severe AS may benefit after TAVR. By inhibiting angiotensin II, RAS blockade may attenuate adverse left ventricular remodeling after the procedure by blocking the hypertrophic signaling and fibrosis to which angiotensin II contributes in AS. Some preliminary studies have suggested favorable effects of RAS blockers on LVH regression and improvement of left ventricular function after valve replacement, but current evidence is insufficient, and data in TAVR patients with LVH are particularly limited. Among RAS blockers, an ACEi was recently studied in a small randomized trial in patients who had undergone TAVR, in which approximately 10% of patients discontinued the study drug because of dry cough. The ARBITAR trial therefore evaluates the clinical efficacy of an ARB used after TAVR in patients with severe AS and LVH.

Objective To evaluate whether an ARB improves clinical outcomes and patient symptoms, and reduces LVH, in patients with severe AS and LVH who have undergone TAVR.

Study Design ARBITAR is a multicenter, prospective, open-label, randomized, investigator-initiated trial. Patients with severe AS and LVH who have undergone TAVR are randomized 1:1 to an experimental group receiving an ARB and a control group receiving no ARB. The funding organization provides financial support only and does not participate in any aspect of the study, including study design, site selection, conduct, management, data collection, or statistical analysis. The study is conducted in accordance with the Declaration of Helsinki, and all participants provide written informed consent at enrollment.

Randomization and Blinding Patients who provide written informed consent and meet all inclusion and exclusion criteria are randomized 1:1 to the experimental or control group. Randomization is stratified by participating site and sex and is managed independently through a web-based interactive web response service (IWRS) to ensure balanced allocation. As an open-label study, no blinding of treatment assignment is performed. Approximately 632 patients will be enrolled at multicenter TAVR centers in Korea, and the assigned treatment is continued for up to 24 months of follow-up.

Intervention and Dosing

In the experimental group, one of the following ARBs is administered and up-titrated toward the target daily dose as a principle; treatment may be initiated at the lower starting dose based on clinical need:

Candesartan: starting dose 4-8 mg once daily; target dose 32 mg once daily Losartan: starting dose 25-50 mg once daily; target dose 50-150 mg once daily Valsartan: starting dose 20-40 mg once daily; target dose 160 mg twice daily

The control group does not receive any ARB during the study period. In both groups, concomitant use of ACE inhibitors, direct renin inhibitors, and angiotensin receptor/neprilysin inhibitors (ARNI) is prohibited throughout the study.

Study Assessments and Schedule Follow-up visits are scheduled at 1 month (±15 days), 6 months (±30 days), 12 months (±90 days), and 24 months (±90 days) after enrollment, with additional visits permitted at the investigator's discretion. At screening/baseline, eligibility assessment, informed consent, medical history, demographics, vital signs and physical examination, laboratory tests, procedural data, medication history, NYHA functional class, KCCQ-12, and transthoracic echocardiography are collected. At each follow-up visit, vital signs, laboratory tests (including NT-proBNP), medication review, NYHA class, KCCQ-12, transthoracic echocardiography, clinical outcomes, and adverse events are assessed. Investigators are encouraged to maintain follow-up through in-person visits or telephone contact and to contact patients who miss scheduled visits to minimize underreporting of clinical events.

Endpoints The primary endpoint is the composite of all-cause death or admission for heart failure. Secondary endpoints comprise all-cause death, cardiovascular death, any admission, admission for heart failure, myocardial infarction, stroke (ischemic and/or hemorrhagic), and redo aortic valve replacement (TAVR or surgical AVR). Other secondary endpoints include echocardiographic measurements (LVEF, peak aortic velocity, peak transaortic gradient, mean transaortic gradient, aortic valve area, aortic valve area index, and aortic regurgitation), NT-proBNP, NYHA functional class, and KCCQ-12 overall summary score.

Endpoint Definitions Endpoint definitions are based on the Valve Academic Research Consortium-3 (VARC-3) criteria. Cardiovascular death is defined as death due to a clear cardiovascular cause (e.g., heart failure, cardiogenic shock, prosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, cardiac tamponade, vascular complication, arrhythmia or conduction disorder, or cardiovascular infection such as mediastinitis or endocarditis), intraprocedural death, sudden death, or death of undetermined cause. Admission for heart failure is defined as hospitalization of at least 24 hours for new or worsening heart failure that is confirmed by signs and symptoms together with diagnostic testing and requires intravenous pharmacologic therapy or mechanical heart failure therapies. All endpoints are first evaluated by the investigator and subsequently adjudicated by an independent adjudicator before final determination.

Statistical Analysis The primary efficacy analysis is performed on the full analysis set according to the intention-to-treat principle; safety analysis is performed on the safety set. For the primary endpoint, time-to-event data are estimated and visualized with the Kaplan-Meier method, between-group differences are tested with a stratified log-rank test adjusted for stratification factors, and the treatment effect is expressed as a hazard ratio with 95% confidence interval from a Cox proportional hazards model, with verification of the proportional hazards assumption. Secondary endpoints are analyzed using the same principles while accounting for competing risk: for endpoints other than all-cause death, all-cause death is treated as a competing-risk event, cumulative incidence is compared using the cumulative incidence function, and a Fine and Gray model is used to estimate subdistribution hazard ratios with 95% confidence intervals. Other secondary endpoints (echocardiographic measurements, NT-proBNP, NYHA class, KCCQ-12) are summarized at baseline and follow-up time points and compared between and within groups using appropriate parametric or nonparametric tests. Safety is evaluated through adverse events of special interest.

Study Oversight The study is overseen by an Executive Committee, an independent Data Safety and Monitoring Board (DSMB), and a Clinical Event Adjudication Committee (CEAC) composed of independent cardiologists who adjudicate protocol-defined clinical events in a blinded manner. Data are collected through a web-based electronic case report form (eCRF) system, and clinical research associates conduct site monitoring, including source data verification.

Being tested
Angiotensin Receptor Blocker (ARB)
Keywords
Severe aortic stenosis, Renin-angiotensin system blockade, Angiotensin receptor blocker, Transcatheter aortic valve replacement (TAVR), Left ventricular hypertrophy
Medical subject headings
Hypertrophy, Left Ventricular, Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Angiotensin Receptor Blocker (ARB)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 initiation at a lower starting dose permitted based on clinical need. Doses are:

    candesartan 4-8 mg once daily titrated to 32 mg once daily; 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.

    Up-titration is considered when all of the following are met: standing systolic blood pressure ≥90 mmHg, no symptoms of hypotension, serum creatinine <2.0 mg/dL or <50% increase from baseline, and serum potassium <5.5 mmol/L. If serum potassium exceeds 6.0 mmol/L, the ARB is discontinued and resumed at a low dose once potassium returns below 5.5 mmol/L.

Study groups in NCT07735130
Study groupRoleWhat they receive
Angiotensin Receptor Blocker (ARB) GroupExperimentalParticipants in this group receive an angiotensin receptor blocker (candesartan, losartan, or valsartan) in addition to standard care after TAVR. As a principle, the ARB is up-titrated toward the target daily dose, but it may be initiated at a lower starting dose based on clinical need. Assigned treatment is continued for up to 24 months. ACE inhibitors, direct renin inhibitors, and angiotensin receptor/neprilysin inhibitors are prohibited.
Receives: Drug: Angiotensin Receptor Blocker (ARB)
Control (No ARB) GroupNo interventionParticipants in this group receive standard care after TAVR without any angiotensin receptor blocker during the study period. ACE inhibitors, direct renin inhibitors, and angiotensin receptor/neprilysin inhibitors are also prohibited in this group. Participants are followed for up to 24 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of all-cause death or admission for heart failure

    Time to the first occurrence of either all-cause death or admission for heart failure. Admission for heart failure is defined per VARC-3 criteria as hospitalization of at least 24 hours for new or worsening heart failure that is confirmed by signs and symptoms together with diagnostic testing and requires intravenous pharmacologic therapy or mechanical heart failure therapies.

    Measured: From randomization to 2 years

Secondary outcomes (7)

  1. All-cause death

    Time to death from any cause after randomization.

    Measured: From randomization to 2 years

  2. Cardiovascular death

    Time to death from a cardiovascular cause as defined by VARC-3, including death due to heart failure, cardiogenic shock, prosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, cardiac tamponade, vascular complication, arrhythmia or conduction disorder, or cardiovascular infection, as well as intraprocedural death, sudden death, and death of undetermined cause.

    Measured: From randomization to 2 years

  3. Any admission

    Time to first hospitalization for any cause after randomization.

    Measured: From randomization to 2 years

  4. Admission for heart failure

    Time to first hospitalization for new or worsening heart failure, defined per VARC-3 as an admission of at least 24 hours confirmed by signs and symptoms together with diagnostic testing and requiring intravenous pharmacologic therapy or mechanical heart failure therapies.

    Measured: From randomization to 2 years

  5. Myocardial infarction

    Time to first myocardial infarction as defined by VARC-3 criteria.

    Measured: From randomization to 2 years

  6. Stroke (ischemic and/or hemorrhagic)

    Time to first stroke, including ischemic and/or hemorrhagic stroke, as defined by VARC-3 criteria.

    Measured: From randomization to 2 years

  7. Redo aortic valve replacement (redo-AVR)

    Time to first repeat aortic valve replacement procedure, by either transcatheter or surgical approach.

    Measured: From randomization to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start15 Aug 2026 (estimated)
  3. Primary completion15 Jun 2030 (estimated)
  4. Study completion15 Jun 2030 (estimated)

Resources

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
Model description
Eligible patients are randomized in a 1:1 ratio to one of two parallel groups: an experimental group receiving an angiotensin receptor blocker (ARB) and a control group receiving no ARB. Randomization is stratified by participating site and sex and is managed through an independent web-based interactive web response service (IWRS). This is an open-label study, so treatment assignment is not blinded; however, protocol-defined clinical endpoints are adjudicated by an independent, blinded Clinical Event Adjudication Committee. The assigned treatment is continued for up to 24 months of follow-up, with visits at 1, 6, 12, and 24 months.
Masking
None (open label)
Enrolment
632 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07735130
Sponsor's protocol ID
H-2601-159-1713
Acronym
ARBITAR
Status last verified
Jul 2026
First submitted
10 Jun 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cleland JG, Tendera M, Adamus J, Freemantle N, Polonski L, Taylor J; PEP-CHF Investigators. The perindopril in elderly people with chronic heart failure (PEP-CHF) study. Eur Heart J. 2006 Oct;27(19):2338-45. doi: 10.1093/eurheartj/ehl250. Epub 2006 Sep 8.

    PubMed 16963472

  • Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

    PubMed 30883053

  • Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

    PubMed 30883058

  • Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.

    PubMed 28304219

  • Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.

    PubMed 27040324

  • Amat-Santos IJ, Lopez-Otero D, Nombela-Franco L, Peral-Disdier V, Gutierrez-Ibanes E, Jimenez-Diaz V, Munoz-Garcia A, Del Valle R, Regueiro A, Ibanez B, Romaguera R, Cuellas Ramon C, Garcia B, Sanchez PL, Gomez-Herrero J, Gonzalez-Juanatey JR, Tirado-Conte G, Fernandez-Aviles F, Raposeiras-Roubin S, Revilla-Orodea A, Lopez-Diaz J, Gomez I, Carrasco-Moraleja M, San Roman JA. Ramipril After Transcatheter Aortic Valve Implantation in Patients Without Reduced Ejection Fraction: The RASTAVI Randomized Clinical Trial. J Am Heart Assoc. 2024 Oct;13(19):e035460. doi: 10.1161/JAHA.124.035460. Epub 2024 Sep 18.

    PubMed 39291483

  • Brilla CG, Funck RC, Rupp H. Lisinopril-mediated regression of myocardial fibrosis in patients with hypertensive heart disease. Circulation. 2000 Sep 19;102(12):1388-93. doi: 10.1161/01.cir.102.12.1388.

    PubMed 10993857

  • Goel SS, Kleiman NS, Zoghbi WA, Reardon MJ, Kapadia SR. Renin-Angiotensin System Blockade in Aortic Stenosis: Implications Before and After Aortic Valve Replacement. J Am Heart Assoc. 2020 Sep 15;9(18):e016911. doi: 10.1161/JAHA.120.016911. Epub 2020 Sep 6.

    PubMed 32893727

  • Basile C, Mancusi C, Franzone A, Avvedimento M, Bardi L, Angellotti D, Castiello DS, Mariani A, Manzo R, De Luca N, Cirillo P, De Simone G, Esposito G. Renin-angiotensin system inhibitors reduce cardiovascular mortality in hypertensive patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: insights from the EffecTAVI registry. Front Cardiovasc Med. 2023 Aug 24;10:1234368. doi: 10.3389/fcvm.2023.1234368. eCollection 2023.

    PubMed 37692038

  • Chen S, Redfors B, Nazif T, Kirtane A, Crowley A, Ben-Yehuda O, Kapadia S, Finn MT, Goel S, Lindman BR, Alu MC, Chau KH, Thourani VH, Vahl TP, Douglas PS, Kodali SK, Leon MB. Impact of renin-angiotensin system inhibitors on clinical outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement: an analysis of from the PARTNER 2 trial and registries. Eur Heart J. 2020 Feb 21;41(8):943-954. doi: 10.1093/eurheartj/ehz769.

    PubMed 31711153

  • Inohara T, Manandhar P, Kosinski AS, Matsouaka RA, Kohsaka S, Mentz RJ, Thourani VH, Carroll JD, Kirtane AJ, Bavaria JE, Cohen DJ, Kiefer TL, Gaca JG, Kapadia SR, Peterson ED, Vemulapalli S. Association of Renin-Angiotensin Inhibitor Treatment With Mortality and Heart Failure Readmission in Patients With Transcatheter Aortic Valve Replacement. JAMA. 2018 Dec 4;320(21):2231-2241. doi: 10.1001/jama.2018.18077.

    PubMed 30512100

  • Goel SS, Aksoy O, Gupta S, Houghtaling PL, Tuzcu EM, Marwick T, Mihaljevic T, Svensson L, Blackstone EH, Griffin BP, Stewart WJ, Barzilai B, Menon V, Kapadia SR. Renin-angiotensin system blockade therapy after surgical aortic valve replacement for severe aortic stenosis: a cohort study. Ann Intern Med. 2014 Nov 18;161(10):699-710. doi: 10.7326/M13-1505.

    PubMed 25402513

  • Kammerlander AA, Nitsche C, Dona C, Koschutnik M, Dannenberg V, Mascherbauer K, Schonbauer R, Zafar A, Winter MP, Bartko PE, Goliasch G, Hengstenberg C, Mascherbauer J. Heart failure with preserved ejection fraction after left-sided valve surgery: prevalent and relevant. Eur J Heart Fail. 2021 Dec;23(12):2008-2016. doi: 10.1002/ejhf.2345. Epub 2021 Oct 4.

    PubMed 34506046

  • Ito N, Zen K, Takahara M, Tani R, Nakamura S, Fujimoto T, Takamatsu K, Yashige M, Kadoya Y, Yamano M, Yamano T, Nakamura T, Yaku H, Matoba S. Left ventricular hypertrophy as a predictor of cardiovascular outcomes after transcatheter aortic valve replacement. ESC Heart Fail. 2023 Apr;10(2):1336-1346. doi: 10.1002/ehf2.14305. Epub 2023 Feb 1.

    PubMed 36725669

  • Palmiero P, Zito A, Maiello M, Cameli M, Modesti PA, Muiesan ML, Novo S, Saba PS, Scicchitano P, Pedrinelli R, Ciccone MM. Left ventricular diastolic function in hypertension: methodological considerations and clinical implications. J Clin Med Res. 2015 Mar;7(3):137-44. doi: 10.14740/jocmr2050w. Epub 2014 Dec 29.

    PubMed 25584097

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Angiotensin Receptor Blocker (ARB) in people with Transcatheter Aortic Valve Replacement (TAVR) and Left Ventricular Hypertrophy, run by Seoul National University Hospital at 1 site 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jung-Kyu Han, MD, PhD (+82-2-2072-4870, hpcrates@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause death or admission for heart failure (time frame: From randomization to 2 years). 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 NCT07735130, which also lists 17 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 29 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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