AzTrials
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Aortic StenosisPhase 2NCT05646381

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

A Phase 2 study testing Pelacarsen (TQJ230) 80mg in people with Aortic Stenosis, run by Novartis Pharmaceuticals at 140 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Aortic Stenosis
What is being tested?
Pelacarsen (TQJ230) 80mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
502 participants
Where
140 sitesin 15 countries
Study dates
7 Mar 2024to 12 Mar 2030
Phase
Phase 2
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female ≥50 to <80 years of age at Screening Part II
  • Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
  • Mild or moderate calcific aortic valve stenosis
  • At the randomization visit, participant must be optimally treated for existing CV risk factors

Who cannot join

  • Severe calcific aortic valve stenosis
  • Uncontrolled hypertension
  • History of malignancy of any organ system
  • History of hemorrhagic stroke or other major bleeding
  • Platelet count ≤ LLN
  • Active liver disease or hepatic dysfunction
Show all 9Show fewer
  • Significant kidney disease
  • Pregnant or nursing women
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

140 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

140 sites in 15 countries

United States38 sites, 33 recruiting

  • Capital Cardiology Associates

    Albany, New York, 12211

    Shreya Shah, sshah@capitalcardiology.com

    Lance Sullenberger

    Recruiting

  • Cardiovascular Res Found

    Beverly Hills, California, 90210

    Juan Ramos, +1 310 278 3400, juan.ramos@cvmg.com

    Ronald P Karlsberg

    Recruiting

  • National Heart Institute

    Beverly Hills, California, 90211

    Maria Flores, +1 301 289 5221, mflores@nationalheartinstitute.org

    Norman Lepor

    Recruiting

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida, 33434

    Withdrawn

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Veronique Recile, +1 617 636 5897

    Benjamin Wessler

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Victoria Viscosi, +1 813 943 3440, vviscosi@mgh.harvard.edu

    Michael Honigberg

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Victoria Viscosi, vviscosi@mgh.harvard.edu

    Michael Honigberg

    Recruiting

  • Brigham and Womens Hosp Harvard Med School

    Boston, Massachusetts, 02115

    Sam Wong, +1 617 347 8680, swong1@bwh.harvard.edu

    Rhanderson Cardoso

    Recruiting

  • Brigham and Womens Hosp Harvard Med School

    Boston, Massachusetts, 02115

    Sam Wong, +1 617 525 1227, swong1@bwh.harvard.edu

    Rhanderson Cardoso

    Recruiting

  • Nova Clinical Research LLC

    Bradenton, Florida, 34209

    Sade Andrews, +1 941 792 6564, sade.andrews@novaclinicalresearch.com

    Christian Zellner

    Recruiting

  • Lindner Ctr At The Christ Hosp

    Cincinnati, Ohio, 45219

    Meghan Grone, +1 513 585 1777, Meghan.Grone@thechristhospital.com

    Sitaramesh Emani

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Withdrawn

  • Flourish Clinical Resrch Covin

    Covina, California, 91723

    Sarita Garcia, +1 714 299 2412, sgarcia@flourishresearch.com

    Fahed Bitar

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Jodi Carter, BS, CCRP, +1 (313) 916-3613

    Khaled Abdul-Nour

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Jodi Carter, +1 313 590 2407, jcarte23@hfhs.org

    Khaled Abdul-Nour

    Recruiting

  • Virginia Heart

    Falls Church, Virginia, 22042

    Oyinda Agbale, +1 703 766 5920, oagbale@virginiaheart.com

    Tariq Haddad

    Recruiting

  • AA Medical Research Center

    Flint, Michigan, 48504

    Fayyaz Shah, +1 810 237 1125, fshah@aamrc.net

    Ahmed A Arif

    Recruiting

  • Texas Heart Institute

    Houston, Texas, 77030

    Dominique Robertson, +1 832 355 8520, dominique.robertson@bcm.edu

    Alexander Postalian

    Recruiting

  • Orion Medical

    Houston, Texas, 77034

    Lena Olivera Perez, lena.oliveraperez@usheartandvascular.com

    Karan Bhalla

    Recruiting

  • Heart Center Research Llc

    Huntsville, Alabama, 35801

    Amy Williams, +1 256 519 8255, awilliams@theheartcenter.md

    Vernon R Hunter

    Recruiting

  • Carient Heart and Vascular

    Manassas, Virginia, 20109

    Hameeda Tasneem, +1 70 333 58 750, htasneem@carient.com

    Vikram Prasanna

    Recruiting

  • Flourish Res Acq LLC North Miami

    Miami, Florida, 33138

    Ashlee Sealy, asealy@flourishresearch.com

    Rimsky Denis

    Recruiting

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014

    Dora Gutierrez, +1 786 502 4303, dgutierrez@inpatientresearch.com

    Alexis Gutierrez

    Recruiting

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

    Withdrawn

  • University Of Minnesota

    Minneapolis, Minnesota, 55455

    Michelle Pitt, +1 612 624 4948, henni032@umn.edu

    Daniel Duprez

    Recruiting

  • Advanced Research for Health Improvement LLC

    Naples, Florida, 34102

    Withdrawn

  • New York Presbyterian Hospital

    New York, New York, 10021

    Active, not recruiting

  • Icahn School of Med at Mt Sinai

    New York, New York, 10029

    Jay Krishna Katragadda, +1 212 659 9174, jaykrishna.katragadda@mssm.edu

    Robert Rosenson

    Recruiting

  • Valley Clinical Trials

    Northridge, California, 91325

    Haydee Gutierrez, +1 818 280 4220, haydee@valleyclinicaltrials.com

    Mehrdad Ariani

    Recruiting

  • Midwest Heart and Vascular Spec

    Overland Park, Kansas, 66211

    Elizabeth Fulks, +1 913 253 3000, Elizabeth.fulks@hcahealthcare.com

    Vasvi Singh

    Recruiting

  • Stanford University Medical Center

    Palo Alto, California, 94304

    Tamara Bazouzi, +1 650 736 7878, bazouzit@stanford.edu

    Abha Khandelwal

    Recruiting

  • Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104

    Manali Shah, manali.shah2@pennmedicine.upenn.edu

    Archna Bajaj

    Recruiting

  • Strong Memorial Hospital

    Rochester, New York, 14642

    Ferogh Shakouri, +1 716 275 7753, ferogh_shakouri@URMC.Rochester.edu

    Robert Block

    Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-4192

    Rachel Wylie, +1 248 551 4192, rachel.wylie@corewellhealth.org

    Joel Skaistis

    Recruiting

  • University Of California San Diego

    San Diego, California, 92103-8415

    Ruby Swaim, +1 858 246 2510, rswaim@health.ucsd.edu

    Anna Narezkina

    Recruiting

  • UC San Francisco Medical Center

    San Francisco, California, 94143

    Liliann Zou, +1 415 514 3156, liliann.zou@ucsf.edu

    Eveline Stock

    Recruiting

  • Overlook Medical Center

    Summit, New Jersey, 07901

    Rosmery Montesino, +1 908 522 6279, Rosmery.montesino@atlantichealth.org

    Robert Fishberg

    Recruiting

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Donna Davis, donna.h.davis@advocatehealth.org

    Michael Shapiro

    Recruiting

Other trials in United States

Germany15 sites, 14 recruiting

  • Novartis Investigative Site

    Ahaus, 48683

    Recruiting

  • Novartis Investigative Site

    Berlin, 13353

    Recruiting

  • Novartis Investigative Site

    Bonn, 53105

    Recruiting

  • Novartis Investigative Site

    Dresden, Saxony, 01099

    Recruiting

  • Novartis Investigative Site

    Essen, 45147

    Recruiting

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60594

    Recruiting

  • Novartis Investigative Site

    Hamburg, 20246

    Recruiting

  • Novartis Investigative Site

    Hamburg, 22763

    Recruiting

  • Novartis Investigative Site

    Kaiserslautern, Rhineland-Palatinate, 67655

    Recruiting

  • Novartis Investigative Site

    Leipzig, Saxony, 04289

    Recruiting

  • Novartis Investigative Site

    Lüneburg, 21339

    Withdrawn

  • Novartis Investigative Site

    Mannheim, 68165

    Recruiting

  • Novartis Investigative Site

    München, 80636

    Recruiting

  • Novartis Investigative Site

    Münster, 48149

    Recruiting

  • Novartis Investigative Site

    Oldenburg, 26133

    Recruiting

Other trials in Germany

Italy12 sites, 11 recruiting

  • Novartis Investigative Site

    Ancona, AN, 60126

    Recruiting

  • Novartis Investigative Site

    Bergamo, BG, 24127

    Recruiting

  • Novartis Investigative Site

    Bologna, BO, 40138

    Withdrawn

  • Novartis Investigative Site

    Brescia, BS, 25123

    Recruiting

  • Novartis Investigative Site

    Caserta, CE, 81100

    Recruiting

  • Novartis Investigative Site

    Cona, FE, 44124

    Recruiting

  • Novartis Investigative Site

    Milan, MI, 20138

    Recruiting

  • Novartis Investigative Site

    Milan, MI, 20157

    Recruiting

  • Novartis Investigative Site

    Milan, MI, 20162

    Recruiting

  • Novartis Investigative Site

    Padova, PD, 35128

    Recruiting

  • Novartis Investigative Site

    Pordenone, PN, 33170

    Recruiting

  • Novartis Investigative Site

    Pozzilli, IS, 86077

    Recruiting

Other trials in Italy

United Kingdom12 sites, 12 recruiting

  • Novartis Investigative Site

    Edinburgh, EH16 4SA

    Recruiting

  • Novartis Investigative Site

    Leicester, LE3 9QP

    Recruiting

  • Novartis Investigative Site

    Liverpool, L14 3PE

    Recruiting

  • Novartis Investigative Site

    London, EC1A 7BE

    Recruiting

  • Novartis Investigative Site

    London, SE1 7EH

    Recruiting

  • Novartis Investigative Site

    Londonderry, BT47 6SB

    Recruiting

  • Novartis Investigative Site

    Manchester, M23 9LT

    Recruiting

  • Novartis Investigative Site

    Middlesbrough, TS4 3BW

    Recruiting

  • Novartis Investigative Site

    Norwich, NR4 7UY

    Recruiting

  • Novartis Investigative Site

    Portadown, Nothern Ireland, BT63 5QQ

    Recruiting

  • Novartis Investigative Site

    Reading, Berkshire, RG1 5AN

    Recruiting

  • Novartis Investigative Site

    Tyne and Wear, NE29 8NH

    Recruiting

Other trials in United Kingdom

Israel9 sites, 9 recruiting

  • Novartis Investigative Site

    Beersheba, 8457108

    Recruiting

  • Novartis Investigative Site

    Haifa, 3104802

    Recruiting

  • Novartis Investigative Site

    Haifa, 3109601

    Recruiting

  • Novartis Investigative Site

    Jerusalem, 9103102

    Recruiting

  • Novartis Investigative Site

    Jerusalem, 9112001

    Recruiting

  • Novartis Investigative Site

    Nahariya, 2210001

    Recruiting

  • Novartis Investigative Site

    Petah Tikva, 4941492

    Recruiting

  • Novartis Investigative Site

    Ramat Gan, 5265601

    Recruiting

  • Novartis Investigative Site

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Spain8 sites, 7 recruiting

  • Novartis Investigative Site

    Cáceres, Extremadura, 10003

    Recruiting

  • Novartis Investigative Site

    Córdoba, 14004

    Recruiting

  • Novartis Investigative Site

    Madrid, 28034

    Recruiting

  • Novartis Investigative Site

    Madrid, 28040

    Withdrawn

  • Novartis Investigative Site

    Madrid, 28041

    Recruiting

  • Novartis Investigative Site

    Madrid, 28046

    Recruiting

  • Novartis Investigative Site

    Salamanca, 37007

    Recruiting

  • Novartis Investigative Site

    Valencia, 46010

    Recruiting

Other trials in Spain

Canada7 sites, 7 recruiting

  • Novartis Investigative Site

    Cambridge, Ontario, N1R 6V6

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H1T 1C8

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1

    Recruiting

  • Novartis Investigative Site

    North York, Ontario, M6B 3H7

    Recruiting

  • Novartis Investigative Site

    Ottawa, Ontario, K1Y 4W7

    Recruiting

  • Novartis Investigative Site

    Québec, Quebec, G1V 4G5

    Recruiting

Other trials in Canada

France6 sites, 6 recruiting

  • Novartis Investigative Site

    Paris, 75012

    Recruiting

  • Novartis Investigative Site

    Paris, 75013

    Recruiting

  • Novartis Investigative Site

    Paris, 75015

    Recruiting

  • Novartis Investigative Site

    Pessac, 33604

    Recruiting

  • Novartis Investigative Site

    Poitiers, 86021

    Recruiting

  • Novartis Investigative Site

    Rennes, 35033

    Recruiting

Other trials in France

Austria5 sites, 4 recruiting

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

    Recruiting

  • Novartis Investigative Site

    Linz, 4021

    Withdrawn

  • Novartis Investigative Site

    Vienna, 1100

    Recruiting

  • Novartis Investigative Site

    Vienna, 1190

    Recruiting

  • Novartis Investigative Site

    Vienna, A 1090

    Recruiting

Other trials in Austria

Belgium5 sites, 5 recruiting

  • Novartis Investigative Site

    Aalst, Oost Vlaanderen, 9300

    Recruiting

  • Novartis Investigative Site

    Genk, Limburg, 3600

    Recruiting

  • Novartis Investigative Site

    Kortrijk, West-Vlaanderen, 8500

    Recruiting

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen, 8800

    Recruiting

  • Novartis Investigative Site

    Yvoir, Namur, 5530

    Recruiting

Other trials in Belgium

Czechia5 sites, 5 recruiting

  • Novartis Investigative Site

    Hradec Králové, 500 02

    Recruiting

  • Novartis Investigative Site

    Jaroměř, 551 01

    Recruiting

  • Novartis Investigative Site

    Prague, 128 08

    Recruiting

  • Novartis Investigative Site

    Prague, 14021

    Recruiting

  • Novartis Investigative Site

    Prague, 150 06

    Recruiting

Other trials in Czechia

Netherlands5 sites, 5 recruiting

  • Novartis Investigative Site

    Amsterdam, North Holland, 1090 HM

    Recruiting

  • Novartis Investigative Site

    Amsterdam, North Holland, 1105 AZ

    Recruiting

  • Novartis Investigative Site

    Nieuwegein, Utrecht, 3435 CM

    Recruiting

  • Novartis Investigative Site

    Rotterdam, South Holland, 3015 GD

    Recruiting

  • Novartis Investigative Site

    Rotterdam, South Holland, 3079 DZ

    Recruiting

Other trials in Netherlands

Switzerland5 sites, 4 recruiting

  • Novartis Investigative Site

    Basel, 4031

    Recruiting

  • Novartis Investigative Site

    Geneva, 1211

    Recruiting

  • Novartis Investigative Site

    Lausanne, 1011

    Recruiting

  • Novartis Investigative Site

    Lugano, 6900

    Recruiting

  • Novartis Investigative Site

    Zurich, 8091

    Withdrawn

Other trials in Switzerland

Denmark4 sites, 4 recruiting

  • Novartis Investigative Site

    Esbjerg, 6700

    Recruiting

  • Novartis Investigative Site

    Hvidovre, 2650

    Recruiting

  • Novartis Investigative Site

    Roskilde, 4000

    Recruiting

  • Novartis Investigative Site

    Viborg, 8800

    Recruiting

Other trials in Denmark

Portugal4 sites, 4 recruiting

  • Novartis Investigative Site

    Alcabideche, 2755-009

    Recruiting

  • Novartis Investigative Site

    Braga, 4710243

    Recruiting

  • Novartis Investigative Site

    Coimbra, 3004-561

    Recruiting

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434 502

    Recruiting

Other trials in Portugal

About this study

Official title: A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

Conditions
Aortic Stenosis
Being tested
Pelacarsen (TQJ230) 80mg, Matching placebo
Keywords
Cardiovascular, Lipoprotein(a), Lp(a), Hyperlipoproteinemia(a), Calcific aortic valve stenosis, TQJ230, Pelacarsen, Aortic valve stenosis, Aortic stenosis
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.

  • Pelacarsen (TQJ230) 80mgDrug

    Also called TQJ230

    Pelacarsen (TQJ230) 80mg

  • Matching placeboDrug

    Also called Placebo

    Matching placebo

Study groups in NCT05646381
Study groupRoleWhat they receive
Pelacarsen (TQJ230) 80mgExperimentalPelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
Receives: Drug: Pelacarsen (TQJ230) 80mg
Matching placeboPlacebo comparatorPlacebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
Receives: Drug: Matching placebo

What is being measured

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

  1. Change in peak aortic jet velocity

    To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography

    Measured: 36 months

  2. Change in aortic valve calcium score

    To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography

    Measured: 36 months

Secondary outcomes (3)

  1. Change in Lp(a) levels

    To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12

    Measured: 12 months

  2. Change in fibrocalcific thickening of the aortic valve

    To assess the effect of pelacarsen (TQJ230) vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in fibrocalcific thickening of the aortic valve by contrast CT

    Measured: 36 months

  3. Time from randomization to first occurrence of composite clinical endpoint event

    To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either:

    1. Unplanned CAVS related hospital admission
    2. Aortic valve intervention
    3. Death related to calcific aortic valve stenosis

    Measured: Up to 36 months

Timeline

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

  1. First posted12 Dec 2022
  2. Study start7 Mar 2024
  3. Primary completion12 Mar 2030 (estimated)
  4. Study completion12 Mar 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
502 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05646381
Sponsor's protocol ID
CTQJ230A12203
Status last verified
Jun 2026
First submitted
2 Dec 2022
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with the applicable laws and regulations.
Expanded access
Available

Publications

  • Aksoy O, Tintut Y, Demer LL. Lipids and lipoproteins in calcific aortic valve disease. Curr Opin Lipidol. 2026 Aug 13. doi: 10.1097/MOL.0000000000001053. Online ahead of print.

    PubMed 42592935

  • Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.

    PubMed 39329200

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pelacarsen (TQJ230) 80mg in people with Aortic Stenosis, run by Novartis Pharmaceuticals at 140 sites in 15 countries.

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 4 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Germany, Italy, United Kingdom, Israel and 10 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in peak aortic jet velocity (time frame: 36 months). The study lists 2 primary outcomes in all. 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 NCT05646381, which also lists 2 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 23 Jun 2026.

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