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Obstructive Hypertrophic Cardiomyopathy (oHCM)Phase 3MAPLE-HCMNCT05767346

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM

A Phase 3 study testing Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg) and Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg) in people with Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Cytokinetics at 71 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg) and Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
71 sitesin 13 countries
Study dates
20 Jun 2023to 28 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who meet all the following criteria at screening may be included in the trial:
  • Males and females between 18 to 85 years of age, inclusive, at screening
  • Body mass index < 35 kg/m2
  • Diagnosed with oHCM per the following criteria by cardiac magnetic resonance imaging (CMR) or echocardiography -
  • Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease and
  • Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory:
Show all 16Show fewer
  • ≥ 15 mm in one or more myocardial segments OR
  • ≥ 13 mm in one or more wall segments and a known disease-causing gene mutation or positive family history of HCM
  • New York Heart Association (NYHA) class II or III
  • Has a Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) score of ≤ 90 at screening
  • Has a screening echocardiogram with the following determined by the echocardiography core laboratory:
  • Resting left ventricular outflow tract gradient (LVOT-G) > 30 mm Hg and/or post-Valsalva LVOT-G ≥ 50 mmHg at screening AND
  • LVEF ≥ 60%
  • Hemoglobin ≥ 10g/dL
  • Respiratory exchange ratio (RER) ≥ 1.05 and peak oxygen uptake (pVO2) < 100% predicted on the screening cardiopulmonary exercise testing (CPET) per the core laboratory
  • Patients previously exposed to mavacamten are allowed to participate but must be off mavacamten for at least 8 weeks

Who cannot join

  • Any of the following criteria will exclude potential participants from the trial:
  • Medical indication for either beta blocker or calcium-channel blockers prohibiting drug discontinuation other than oHCM
  • History of intolerance or medical contraindication to beta blocker therapy
  • Resting Systolic Blood Pressure (SBP) of > 160 mmHg
  • Resting heart rate of > 100 bpm
  • Significant valvular heart disease
Show all 18Show fewer
  • Moderate-severe valvular aortic stenosis or fixed subaortic obstruction
  • Mitral regurgitation not due to systolic anterior motion of the mitral valve (per Investigator judgment)
  • Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
  • History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy at any time during their clinical course
  • Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
  • Documented room air oxygen saturation reading < 90% at screening
  • Planned septal reduction treatment that cannot be deferred during the trial period
  • History of septal reduction therapy (surgical myectomy or alcohol septal ablation) within 6 months of screening
  • History of paroxysmal or persistent atrial fibrillation or atrial flutter. Atrial flutter treated with radio frequency ablation without recurrence within the last 6 months prior to screening is allowed.
  • Current or recent (< 4 weeks) therapy with disopyramide
  • History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
  • Has received prior treatment with aficamten or previously intolerant (reduced LVEF requiring permanent drug discontinuation) to mavacamten

Trial locations and contacts

71 sites in 13 countries.

71 sites in 13 countries

United States28 sites

  • Alaska Heart and Vascular Institute

    Anchorage, Alaska, 99508

  • Emory Clinic

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01803

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Sanger Heart & Vascular Institute - HCM Clinic

    Charlotte, North Carolina, 28204

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Northwestern University

    Evanston, Illinois, 60208

  • Inova Schar Heart and Vascular

    Falls Church, Virginia, 22042

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • CHI St. Luke's Health Baylor-St. Luke's Medical Center

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • UC San Diego Health - Sulpizio Cardiovascular Center

    La Jolla, California, 92037

  • Cedars-Sinai Medical Center (Smidt Heart Institute)

    Los Angeles, California, 90048

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Duke Health Center Arringdon

    Morrisville, North Carolina, 27560

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Ascension Saint Thomas Heart West

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale New Haven Hospital

    New Haven, Connecticut, 06519

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032

  • AdventHealth

    Orlando, Florida, 32804

  • Division of Heart Failure and Transplantation (Hospital of the University of Pennsylvania)

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

Spain8 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital Clinico Universitario Virgen Arrixaca

    El Palmar

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital Universitario Virgen del Rocio

    Seville

  • Hospital Universitario Virgen Macarena

    Seville

  • Hospital Universitario Son Llatzer

    Son Ferriol

Other trials in Spain

China6 sites

  • Xiangya Second Hospital of Central South University

    Changsha

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Zhongshan Hospital Fudan University

    Shanghai

  • Renmin Hospital of Wuhan University

    Wuhan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

France6 sites

  • CHU La Timone

    Marseille

  • Hopital Europeen Georges Pompidou

    Paris

  • Hopital Lariboisiere - APHP

    Paris

  • Hopital Cardiologique Haut Leveque - CHU de Bordeaux

    Pessac

  • CHU Pontchaillou

    Rennes

  • Hopital Laennec - CHU de Nantes

    Saint-Herblain

Other trials in France

United Kingdom6 sites

  • NHS Greater Glasgow and Clyde

    Glasgow

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool

  • Barts Health NHS Trust

    London

  • Royal Brompton Hospital

    London

  • St George's University Hospitals NHS Foundation Trust

    London

  • Oxford University Hospital NHS Trust - John Radcliffe Hospital - OCMR

    Oxford

Other trials in United Kingdom

Israel5 sites

  • Barzilai Medical Center

    Ashkelon

  • Hadassah Hebrew Medical Center- Ein Kerem

    Jerusalem

  • The Chaim Sheba Medical Center

    Ramat Gan

  • Kaplan Medical Center

    Rehovot

  • Ziv Medical Center

    Safed

Other trials in Israel

Brazil3 sites

  • Instituto de Pesquisa Clinica de Campinas - IPECC

    Campinas, São Paulo, 13060-080

  • Institutdo Danta Pazzanese

    Ibirapuera, 04012-909

  • lnstituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

Germany3 sites

  • Charite-Universitatsmedizin Berlin - Campus Virchow Klinikum

    Berlin

  • Universitaetsklinikum Essen

    Essen

  • Universitaetsklinikum Jena

    Jena

Other trials in Germany

Denmark2 sites

  • Aarhus University Hospital

    Aarhus

  • Copenhagen University Hospital

    Copenhagen

Other trials in Denmark

Canada1 site

  • Institut universitaire de cardiologie et de pneumonlogie de Quebec - Universite Laval

    Québec

Other trials in Canada

Hungary1 site

  • Semmelweis Egyetem, Városmajori Szív- és Érgyógyászati Klinika

    Budapest

Other trials in Hungary

Italy1 site

  • AOU Careggi

    Florence

Other trials in Italy

Netherlands1 site

  • Erasmus Medical Center

    Rotterdam

Other trials in Netherlands

About this study

Official title: A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

Being tested
Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg), Placebo to match aficamten, Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg), Placebo to match metoprolol succinate
Keywords
Obstructive Hypertrophic Cardiomyopathy, Aficamten, Metoprolol, oHCM, CK-3773274, CK-274, MAPLE-HCM, MAPLE, CY 6032
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

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

  • Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg)Drug

    Aficamten (CK-3773274) tablets administered orally

  • Placebo to match aficamtenDrug

    Placebo for aficamten (CK-3773274) administered orally

  • Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)Drug

    Metoprolol succinate tablets administered orally

  • Placebo to match metoprolol succinateDrug

    Placebo for metoprolol succinate administered orally

Study groups in NCT05767346
Study groupRoleWhat they receive
Aficamten up to 20 mg plus placebo for metoprololExperimentalPatients will receive doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten (CK-3773274) plus placebo for metoprolol succinate with dose levels guided by echocardiography assessments for up to 24 weeks.
Receives: Drug: Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg); Drug: Placebo to match metoprolol succinate
Metoprolol succinate up to 200 mg plus placebo for aficamtenActive comparatorPatients will receive 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten (CK-3773274) with dose levels guided by echocardiography and heart rate assessments for up to 24 weeks.
Receives: Drug: Placebo to match aficamten; Drug: Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)

What is being measured

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

  1. Change in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)

    Effect of aficamten compared with metoprolol succinate on exercise capacity in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Exercise capacity was determined through changes in peak oxygen uptake (pVO2) after 24 weeks of treatment. pVO2 was measured by cardiopulmonary exercise testing (CPET) on a treadmill or bicycle. A higher pVO2 indicates better cardiorespiratory fitness.

    Measured: Baseline to Week 24

Secondary outcomes (6)

  1. Proportion of Patients With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class

    Effect of aficamten compared with metoprolol succinate on NYHA Functional Classification

    Measured: Baseline to Week 24

  2. Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)

    Effect of aficamten compared with metoprolol succinate on participant health status was measured by change in KCCQ-CSS. The KCCQ is a patient-reported outcome designed to assess the physical limitations, symptoms, self-efficacy, quality of life, and social limitation of patients with heart failure symptoms. The CSS is the sum of the physical limitation score and the total symptom score. The KCCQ-Clinical Symptoms Score (KCCQ-CSS) is scored on a scale from 0 to 100, with higher scores indicating better physical functioning and symptoms.

    Measured: Baseline to Week 24

  3. Change in Left Ventricular Mass Index (LVMI)

    Effect of aficamten on mass of the heart as compared with metoprolol succinate

    Measured: Baseline to Week 24

  4. Change in Left Atrial Volume Index (LAVI)

    Effect of aficamten on size of the heart as compared with metoprolol succinate

    Measured: Baseline to Week 24

  5. Change From Baseline Values in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)

    Effect of aficamten on NT-proBNP as compared with metoprolol succinate. For change in NT-proBNP from baseline to Week 24, the log transformed proportional change up to Week 24 was analyzed using a mixed model for repeated measures (MMRM) then the estimate was back transformed to obtain the ratio.

    Measured: Baseline to Week 24

  6. Change in Post-Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G)

    Effect of aficamten on post-Valsalva LVOT-G as compared with metoprolol succinate

    Measured: Baseline to Week 24

Timeline

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

  1. First posted14 Mar 2023
  2. Study start20 Jun 2023
  3. Primary completion28 Feb 2025
  4. Study completion28 Mar 2025

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767346
Sponsor's protocol ID
CY 6032
Other IDs
2023-504809-37-00, 2023
Acronym
MAPLE-HCM
Status last verified
Jun 2026
First submitted
2 Mar 2023
Last updated
9 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Dominguez F, Barriales-Villa R, Claggett BL, Dybro A, Ge J, Lakdawala NK, Maron MS, Masri A, Merkely B, Miao ZM, Nair A, Nassif ME, Pena-Pena ML, Schulze PC, Wang A, Hegde SM, Lewis GD, Elliott P, Sohn R, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Berhane I, Wohltman A, Fifer MA, Garcia-Pavia P; MAPLE-HCM Investigators. Efficacy of Aficamten vs Metoprolol According to Pretrial Beta-Blocker Treatment in Obstructive Hypertrophic Cardiomyopathy: Insights From MAPLE-HCM. JACC Heart Fail. 2026 Aug 29:103352. doi: 10.1016/j.jchf.2026.103352. Online ahead of print.

    PubMed 42667283

  • Masri A, Lewis GD, Barriales-Villa R, Claggett BL, Coats CJ, Elliott P, Hagege A, Kulac IJ, Garcia-Pavia P, Fifer MA, Meder B, Olivotto I, Nassif MA, Lakdawala NK, Owens AT, Heitner SB, Jacoby DL, Sohn R, Kupfer S, Malik FI, Wohltman A, Maron MS. The Threshold for a Clinically Meaningful Improvement in Cardiopulmonary Exercise Testing Measures for Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy. J Card Fail. 2026 Aug 20:S1071-9164(26)00500-2. doi: 10.1016/j.cardfail.2026.08.011. Online ahead of print.

    PubMed 42624353

  • Lewis GD, Garcia-Pavia P, Masri A, Merkely B, Nassif ME, Pena-Pena ML, Barriales-Villa R, Bilen O, Burroughs M, Claggett B, Costabel JP, de Barros Correia E, Dybro AM, Kulac IJ, Lakdawala NK, Mann A, Maron MS, McGinnis S, Nair A, Newlands C, Poulsen SH, Reant P, Schulze PC, Solomon SD, Wang A, Sohn R, Berhane I, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Wohltman A, Fifer MA, Elliott PM; MAPLE-HCM Investigators. Exercise Performance With Aficamten vs Metoprolol in Obstructive Hypertrophic Cardiomyopathy: The MAPLE-HCM Randomized Clinical Trial. JAMA Cardiol. 2026 Aug 1;11(8):736-746. doi: 10.1001/jamacardio.2026.1730.

    PubMed 42307914

  • Nassif ME, Garcia-Pavia P, Masri A, Merkely B, Pena-Pena ML, Barriales-Villa R, Bilen O, Burroughs M, Claggett BL, Costabel JP, de Barros Correia E, Dybro AM, Elliott P, Lakdawala NK, Lewis GD, Mann A, Maron MS, Miao ZM, Nair A, Poulsen SH, Reant P, Schulze PC, Solomon SD, Wang A, Sohn R, Berhane I, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Wohltman A, Fifer MA, Spertus JA; MAPLE-HCM Investigators. Effect of Aficamten vs Metoprolol on Patient-Reported Health Status in Obstructive Hypertrophic Cardiomyopathy. J Am Coll Cardiol. 2026 Mar 3;87(8):1046-1058. doi: 10.1016/j.jacc.2025.10.059. Epub 2025 Nov 18.

    PubMed 41493295

  • Wang A, Garcia-Pavia P, Masri A, Merkely B, Nassif ME, Pena-Pena ML, Barriales-Villa R, Bilen O, Burroughs M, Claggett BL, Costabel JP, de Barros Correia E, Dybro A, Elliott P, Hegde SM, Kulac IJ, Lakdawala NK, Lewis GD, Mann A, Nair A, Poulsen SH, Reant P, Schulze PC, Solomon SD, Sohn R, Berhane I, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Wohltman A, Fifer MA, Maron MS; MAPLE-HCM Investigators. Aficamten in Obstructive Hypertrophic Cardiomyopathy: A Multidomain, Patient-Level Analysis of the MAPLE-HCM Trial. J Am Coll Cardiol. 2026 Mar 3;87(8):1029-1042. doi: 10.1016/j.jacc.2025.10.057. Epub 2025 Nov 18.

    PubMed 41348072

  • Hegde SM, Wang X, Garcia-Pavia P, Getchevski S, Masri A, Merkely B, Nassif ME, Pena-Pena ML, Barriales-Villa R, Bilen O, Burroughs M, Claggett B, Costabel JP, Correia EB, Dybro AM, Elliott P, Lakdawala NK, Mann A, Maron MS, Nair A, Poulsen SH, Reant P, Schulze PC, Wang A, Sohn R, Berhane I, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Wohltman A, Fifer MA, Solomon SD; MAPLE-HCM Investigators. Effect of Aficamten Compared With Metoprolol on Echocardiographic Measures in Symptomatic Obstructive Hypertrophic Cardiomyopathy: MAPLE-HCM. J Am Coll Cardiol. 2025 Dec 16;86(24):2452-2467. doi: 10.1016/j.jacc.2025.08.022. Epub 2025 Aug 27.

    PubMed 40932433

  • Garcia-Pavia P, Maron MS, Masri A, Merkely B, Nassif ME, Pena-Pena ML, Barriales-Villa R, Bilen O, Burroughs M, Claggett B, Costabel JP, Correia EB, Dybro AM, Elliott P, Hegde SM, Lakdawala NK, Lewis GD, Mann A, Miao ZM, Nair A, Poulsen SH, Reant P, Schulze PC, Solomon SD, Wang A, Sohn R, Berhane I, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Wohltman A, Fifer MA; MAPLE-HCM Investigators. Aficamten or Metoprolol Monotherapy for Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. 2025 Sep 11;393(10):949-960. doi: 10.1056/NEJMoa2504654. Epub 2025 Aug 30.

    PubMed 40888697

  • Garcia-Pavia P, Bilen O, Burroughs M, Costabel JP, de Barros Correia E, Dybro AM, Elliott P, Lakdawala NK, Mann A, Nair A, Nassif ME, Poulsen SH, Reant P, Schulze PC, Wang A, Berhane I, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Meng L, Sohn R, Wohltman A, Fifer MA; MAPLE-HCM Study Investigators. Aficamten vs Metoprolol for Obstructive Hypertrophic Cardiomyopathy: MAPLE-HCM Rationale, Study Design, and Baseline Characteristics. JACC Heart Fail. 2025 Feb;13(2):346-357. doi: 10.1016/j.jchf.2024.11.011.

    PubMed 39909646

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg) and Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg) in people with Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Cytokinetics at 71 sites in 13 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 16 inclusion and 18 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: finished, as of the sponsor's last update on 9 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 71 sites in United States, Spain, China, France, United Kingdom and 8 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET) (time frame: Baseline to Week 24). 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 NCT05767346, which also lists 8 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 9 Jun 2026.

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