AzTrials
AzTrials

Obstructive Hypertrophic CardiomyopathyDISCOVER-HCMNCT05489705

A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)

An observational study of Obstructive Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 101 sites in 9 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Hypertrophic Cardiomyopathy
What is being tested?
Mavacamten and Non-mavacamten symptomatic oHCM therapy
How many people
1,700 participants
Where
101 sitesin 9 countries
Study dates
16 Aug 2022to 17 Aug 2029
How long will I take part?
5 Years
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will include adult participants with symptomatic obstructive HCM who are receiving pharmacological treatment for obstructive HCM (for example, BBs, non-DHP CCBs, disopyramide, and/or mavacamten) as part of routine care in the United States or Europe.

Who may be able to join

  • ≥ 18 years of age at the time of informed consent.
  • Willing and able to provide written informed consent form (ICF) and any required privacy authorization prior to the initiation of study procedures (or in those situations where consent cannot be given by participants, consent provided by their legally acceptable representatives)
  • United States Sub-Study
  • Diagnosis of obstructive HCM consistent with 2020 American Heart Association/American College of Cardiology (AHA/ACC) guidelines.
  • Obstructive HCM is defined clinically by the presence of increased LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of HCM) in a nondilated ventricular chamber that is not solely explained by abnormal loading conditions (eg, another cardiac or systemic disease) and peak LVOT gradient of ≥ 30 mmHg at rest or with provocation.
  • Has documented LVEF of ≥ 55% recorded by echocardiography within the last 6 months.
Show all 13Show fewer
  • Symptoms consistent with NYHA functional class II-IV.
  • Receiving beta blocker (BB)s, non-dihydropyridine calcium. channel blockers (nonDHP CCBs), disopyramide, and/or mavacamten (once available) as part of routine clinical care; or currently receiving no treatment due to intolerance or failure of prior treatment (eg, BBs, non-DHP CCBs, or disopyramide) for obstructive HCM.
  • European Sub-study
  • Diagnosis of obstructive HCM consistent with the most recent European Society of Cardiology (ESC) and American Heart Association/American College of Cardiology (AHA/ACC) guidelines
  • Documented LVEF of ≥55% recorded by TTE
  • Documented symptoms consistent with NYHA functional class II-III at enrollment or within 6 months prior to enrollment (if not available at enrollment).
  • As part of routine clinical care for obstructive HCM: receiving BBs, non-DHP CCBs, disopyramide; initiating mavacamten at enrollment; or currently receiving no treatment due to intolerance or failure of prior treatment (e.g., BBs, non-DHP CCBs, or disopyramide).

Who cannot join

  • Known phenocopy disease (e.g., Fabry disease, amyloidosis) or LV hypertrophy associated with hypertension.
  • Documentation of any fixed obstruction of the outflow tract such as aortic valve stenosis or replacement.
  • Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to enrollment; participants with an unsuccessful myectomy or percutaneous ASA performed > 6 months prior to enrollment may be enrolled.
  • Naïve to treatment for obstructive HCM (ie, never treated with BBs, nonDHP CCBs, or disopyramide).
  • United States Sub-Study
  • Receiving an investigational therapeutic agent for obstructive HCM (eg, myosin-inhibitors other than mavacamten) in an interventional clinical trial at participant enrollment.
Show all 12Show fewer
  • Previously or currently enrolled in a long-term safety extension study of mavacamten (eg, EXPLORER-HCM [ClinicalTrials.gov, NCT03470545], MAVA-LTE [NCT03723655], PIONEER-OLE [NCT03496168], VALORHCM [NCT04349072], or MAVERICK [NCT03442764])
  • European Sub-study
  • Receiving an investigational therapeutic agent or any cardiac myosin inhibitor and/or modulators for obstructive HCM at patient enrolment
  • Previously or currently enrolled in other HCM registry studies (e.g., TORCH, REMY, EU-PASS)
  • Previously or currently enrolled in a study of mavacamten (e.g., EXPLORER-HCM [ClinicalTrials.gov, NCT03470545], MAVA-LTE [NCT03723655], PIONEER-OLE [NCT03496168], VALOR-HCM [NCT04349072], MAVERICK [NCT03442764], or MEMENTO [NCT2264899])
  • Previously treated with mavacamten

Trial locations and contacts

101 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

101 sites in 9 countries

United States60 sites, 48 recruiting

  • Alaska Heart Institute

    Anchorage, Alaska, 99508

    Ahmed Abuzaid, Site 0023, 907-561-3211

    Recruiting

  • UC Denver, AMC

    Aurora, Colorado, 48377

    David Raymer, Site 0050, 720-848-5300

    Recruiting

  • Local Institution - 0059

    Baltimore, Maryland, 21201

    Active, not recruiting

  • MedStar Health Research Institute

    Baltimore, Maryland, 21218

    Sandeep Jani, Site 0030

    Recruiting

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

    Jamshid Shirani, Site 0043, 718-430-3314

    Recruiting

  • Harvard (Massachusetts General Hospital)

    Boston, Massachusetts, 02114

    Albree Tower-Rader, Site 0024, 617-724-5434

    Recruiting

  • Harvard Medical School - Brigham and Women's Hospital (BWH)

    Boston, Massachusetts, 02215

    Carolyn Ho, Site 0068, 617-732-5500

    Recruiting

  • Focus Clinical Research

    Charlotte, North Carolina, 28207

    Aamer Qurehshi, Site 0040, 888-635-0552

    Recruiting

  • The Rector and Visitors of the Univ of Virginia

    Charlottesville, Virginia, 22908

    Christopher Kramer, Site 0011, 434-982-0853

    Recruiting

  • University of Chicago Dept of Medicine

    Chicago, Illinois, 60637

    Gene Kim, Site 0063, 773-702-9396

    Recruiting

  • Christ Hospital Health Network

    Cincinnati, Ohio, 45219

    Wojciech Mazur, Site 0015, 513-721-8881

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Anene Clair Ukaigwe, Site 0041, 216-286-1023

    Recruiting

  • Local Institution - 0003

    Cleveland, Ohio, 44195

    Active, not recruiting

  • Bassett Medical Center

    Cooperstown, New York, 13326

    Mun Hong, Site 0006, 607-547-4582

    Recruiting

  • North Texas Cardiology Center

    Dallas, Texas, 75208

    Manavjot Sidhu, Site 0018, 214-933-7430

    Recruiting

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246

    Robert Gottlieb, Site 0008

    Recruiting

  • Duke University Health System

    Durham, North Carolina, 27710

    Andrew Wang, Site 0022

    Recruiting

  • Spectrum Health Medical Group

    Grand Rapids, Michigan, 49525

    David Fermin, Site 0073, 616-885-5000

    Recruiting

  • Prisma Health - Upstate

    Greenville, South Carolina, 29605

    Josh Doll, Site 0042, 864-455-7727

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Dmitry Nemirovsky, Site 0029, 551-996-5870

    Recruiting

  • Local Institution - 0067

    Hartford, Connecticut, 06106

    Active, not recruiting

  • Local Institution - 0046

    Honolulu, Hawaii, 96813

    Active, not recruiting

  • The Methodist Hospital, Methodist Cancer Cencer

    Houston, Texas, 77030

    Sherif Nagueh, Site 0058, 713-441-2850

    Recruiting

  • BI Research Center

    Houston, Texas, 77084

    Asif Akhtar, Site 0039, 281-944-3610

    Recruiting

  • Indiana. University

    Indianapolis, Indiana, 46202

    Roopa Rao, Site 0013, 317-962-9700

    Recruiting

  • Franciscan Physician Network-Indiana Heart Physicians

    Indianapolis, Indiana, 46237

    George Lolay, Site 0016, 317-893-1712

    Recruiting

  • Local Institution - 0045

    Iowa City, Iowa, 52242

    Active, not recruiting

  • Local Institution - 0065

    Jacksonville, Florida, 32209

    Active, not recruiting

  • St. Luke's Mid-America Heart Institute

    Kansas City, Missouri, 64111

    Michael Nassif, Site 0069

    Recruiting

  • Local Institution - 0033

    Kansas City, Missouri, 66160

    Active, not recruiting

  • Local Institution - 0037

    La Jolla, California, 92037

    Active, not recruiting

  • Local Institution - 0076

    Lancaster, Pennsylvania, 17603

    Active, not recruiting

  • UAMS

    Little Rock, Arkansas, 72205-7199

    Srikanth Vallurupalli, Site 0007, 501-686-5545

    Recruiting

  • Keck School of Medicine of USC-Usc

    Los Angeles, California, 90033

    Eugene DePasquale, Site 0057, 323-442-6130

    Recruiting

  • Local Institution - 0004

    Madison, Wisconsin, 53792

    Active, not recruiting

  • Medical College of Wisconsin, Inc (PI Address)

    Milwaukee, Wisconsin, 53226

    Abhinav Sharma, Site 0054, 414-805-6000

    Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

    Robert Fraser, Site 0010, 612-863-3900

    Recruiting

  • WVU Hospitals

    Morgantown, West Virginia, 26506

    Christopher Bianco, Site 0055, 304-598-4000

    Recruiting

  • Local Institution - 0026

    Morristown, New Jersey, 07960

    Active, not recruiting

  • Tristar Centennial Medical Ctr

    Nashville, Tennessee, 37203

    Bryan Doherty, Site 0048, 347-949-3060

    Recruiting

  • Saint Thomas Health

    Nashville, Tennessee, 37205-2018

    Mark Zenker, Site 0019, 615-269-4545

    Recruiting

  • Local Institution - 0009

    New York, New York, 10019

    Active, not recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Johanna Contreras, Site 0035, 917-751-5850

    Recruiting

  • CHI Health Reseach Center

    Omaha, Nebraska, 68124

    Amjad Kabach, Site 0070

    Recruiting

  • Stanford Health Care Hospital & Clinics

    Palo Alto, California, 94304

    Matthew Wheeler, Site 0012

    Recruiting

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Timothy Wong, Site 0027

    Recruiting

  • Baylor Scott & White The Heart Hospital Plano

    Plano, Texas, 75093

    David Rawitscher, Site 0028, 469-800-6390

    Recruiting

  • VCU Medical Center

    Richmond, Virginia, 23298

    Mohammed Makkiya, Site 0080, 804-828-9989

    Recruiting

  • Carilion Clinic; Virginia Tech-Carilion School of Medicine

    Roanoke, Virginia, 24014

    Ali Hama Amin, Site 0044, 540-982-8204

    Recruiting

  • Saint Francis Hospital

    Roslyn, New York, 11576

    Allen Jeremias, Site 0075, 631-707-2586

    Recruiting

  • University Of California San Francisco Medical Center

    San Francisco, California, 94117

    Theodore Abraham, Site 0021

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Mariko Harper, Site 0052, 206-341-1111

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Richard Bach, Site 0036, 314-362-1963

    Recruiting

  • Baylor Scott & White Medical Centre - Temple

    Temple, Texas, 76508

    Vinh Nguyen, Site 0051, 254-724-5119

    Recruiting

  • Pima Heart and Vascular

    Tucson, Arizona, 85704

    Greg Koshkarian, Site 0025, 000-000-0000

    Recruiting

  • Cardiology Associates Research, Llc

    Tupelo, Mississippi, 38801

    Barry Bertolet, Site 0062, 904-392-2469

    Recruiting

  • WMCHealth Advanced Physician Services

    Valhalla, New York, 10595

    Srihari Naidu, Site 0053, 914-598-7651

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Patrick Bering, Site 0081, 202-877-5975

    Recruiting

  • Henry Ford Health System

    West Bloomfield, Michigan, 48322

    Karthikeyan Ananthasubramaniam, Site 0034

    Recruiting

  • Geisinger Health System

    Wilkes-Barre, Pennsylvania, 18711

    Vernon Mascarenhas, Site 0056, 570-808-6020

    Recruiting

Other trials in United States

Spain8 sites, 7 recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006

    Ana Merino Merino, Site 0107, +34947281800

    Recruiting

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, Murcia, 30120

    Juan Ramon Gimeno Blanes, Site 0105, +34619068153

    Recruiting

  • Local Institution - 0102

    Madrid, 28007

    Withdrawn

  • Hospital Clinico San Carlos

    Madrid, 28040

    Maria Alejandra Restrepo Cordoba, Site 0108, +34913303944

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

    Pablo García Pavia, Site 0104, +34911917297

    Recruiting

  • Hospital Clinico Universitario Virgen de La Victoria

    Málaga, 29010

    José Manuel García Pinilla, Site 0103, +34951032349

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

    Rebeca Lorca Gutierrez, Site 0106, +3498510800033114

    Recruiting

  • Hospital Fundacion Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198

    Tomas Ripoll, Site 0109, +34871202102

    Recruiting

Other trials in Spain

Austria7 sites, 6 recruiting

  • KH St.Josef Braunau am Inn

    Braunau am Inn, 5280

    Johann Auer, Site 0082, +437722804510

    Recruiting

  • LKH-Univ. Klinikum Graz

    Graz, 8036

    Nicolas Verheyen, Site 0087, +433163851254

    Recruiting

  • Local Institution - 0088

    Innsbruck, 6020

    Site 0088

    Not yet recruiting

  • Local Institution - 0084

    Klagenfurt, 9020

    Withdrawn

  • Kepler Universitätsklinikum Linz

    Linz, 4021

    Christian Reiter, Site 0086, 4357680836220

    Recruiting

  • Local Institution - 0085

    Sankt Pölten, 3100

    Site 0085

    Not yet recruiting

  • Local Institution - 0083

    Vienna, 1090

    Site 0083

    Not yet recruiting

Other trials in Austria

France7 sites, 6 recruiting

  • CHU Amiens-Picardie

    Amiens, Somme, 80054

    Yohann Bohbot, Site 0091, 33322087258

    Recruiting

  • Centre Hospitalier Haguenau

    Haguenau, Bas Rhin, 67500

    Charlotte Dagrenat, Site 0092, 33388063435

    Recruiting

  • Hôpital Saint Vincent-de-Paul

    Lille, Nord, 59000

    Ludovic Appert, Site 0090, 33320874996

    Recruiting

  • Local Institution - 0117

    Montpellier, 34000

    Withdrawn

  • CHU De Poitiers - Hopital De La Miletrie

    Poitiers, Vienne, 86000

    Benjamin Alos, Site 0089, 33549444444

    Recruiting

  • CHU Nantes Hopital Nord Laennec

    Saint-Herblain, Loire Atlantique, 44800

    Nicolas Piriou, Site 0093, +33240165716

    Recruiting

  • Hôpital Sainte Musse

    Toulon, Var, 83000

    Jean-Michel Tartière, Site 0094, 33483772070

    Recruiting

Other trials in France

Germany7 sites, 6 recruiting

  • Ostalb-Klinikum Aalen

    Aalen, Baden-Wurttemberg, 73430

    Stephanie Loebig, Site 0098, 497361550

    Recruiting

  • Kardiologische und angiologische Praxen im Spreebogen

    Berlin, 10719

    Wilhelm Haverkamp, Site 0096, +4930450565906

    Recruiting

  • Immanuel Klinikum Bernau

    Bernau, State of Berlin, 16321

    Christian Butter, Site 0095, +493338694644

    Recruiting

  • Praxisklinik Herz Und Gefasse-Klinikum Weisser Hirsch

    Dresden, Saxony, 01099

    Gregor Simonis, Site 0099, 493518064440

    Recruiting

  • Local Institution - 0101

    Erlangen, Bavaria, 91054

    Withdrawn

  • Universitaetsklinikum Leipzig Aoer

    Leipzig, Saxony, 04103

    Karsten Lenk, Site 0097, +4936419324521000000

    Recruiting

  • Universitatsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149

    Jürgen Sindermann, Site 0100, +492518347426

    Recruiting

Other trials in Germany

United Kingdom7 sites, 6 recruiting

  • Local Institution - 0110

    Birmingham, West Midlands, B15 2GW

    Active, not recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW

    Zaheer Yousef, Site 0116, +442920716008

    Recruiting

  • Leeds General Infirmary

    Leeds, West Yorkshire, LS1 3EX

    Alex Simms, Site 0114, +441133922385

    Recruiting

  • Liverpool Heart and Chest Hospital

    Liverpool, Merseyside, L14 3PE

    Robert Cooper, Site 0111, +441512281616

    Recruiting

  • Local Institution - 0113

    London, Greater London, SW3 6NP

    Site 0113

    Not yet recruiting

  • Imperial College Healthcare NHS Trust

    London, Greater London, W6 8RF

    Amanda Varnava, Site 0115, +447532199693

    Recruiting

  • University Of Manchester

    Manchester, Greater Manchester, M13 9WL

    Andrew Crean, Site 0112, +441612761234

    Recruiting

Other trials in United Kingdom

Czechia2 sites

  • Local Institution - 0002

    Olomouc, 779 00

    Withdrawn

  • Local Institution - 0001

    Prague, 150 00

    Withdrawn

Other trials in Czechia

Poland2 sites

  • Local Institution - 0002

    Katowice, 40-635

    Withdrawn

  • Local Institution - 0001

    Warsaw, 04-628

    Withdrawn

Other trials in Poland

Puerto Rico1 site, 1 recruiting

  • Research & Cardiovascular Corp

    Ponce, 00717-1322

    Jose Vazquez-Tanus, Site 0077, 7872908585

    Recruiting

Other trials in Puerto Rico

About this study

Official title: Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States and European Prospective Registry Study

This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment.

United States Sub-Study: The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting.

Europe Sub-Study: The purpose of this study is to evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting.

Being tested
Mavacamten, Non-mavacamten symptomatic oHCM therapy
Keywords
Obstructive hypertrophic cardiomyopathy, Obstructive HCM (oHCM), Mavacamten, Heart failure, oHCM
Medical subject headings
Cardiomyopathy, Hypertrophic, Heart Failure

What participants receive

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

  • MavacamtenDrug

    As per product label

  • Non-mavacamten symptomatic oHCM therapyDrug

    Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label

Study groups in NCT05489705
Study groupRoleWhat they receive
MavacamtenParticipants will receive mavacamten as prescribed by a physician according to standard of care for symptomatic oHCM
Receives: Drug: Mavacamten
Beta-blocker (BB) / non-dihydropyridine (non-DHP) calcium channel blocker (CCB) / disopyramideParticipants will receive BB/non-DHP CCB/disopyramide as prescribed by a physician according to standard of care for symptomatic oHCM
Receives: Drug: Non-mavacamten symptomatic oHCM therapy

What is being measured

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

  1. Incidence rate of new or worsening heart failure due to systolic dysfunction among participants with symptomatic obstructive HCM during periods of exposure to mavacamten and other oHCM treatment

    Systolic dysfunction defined as symptomatic Left Ventricular Ejection Fraction (LVEF) < 50%. United States participants only.

    Measured: Up to 5 Years

  2. Change in resting left ventricular outflow tract (LVOT) gradient from baseline

    European Participants only

    Measured: Up to 18 months

Secondary outcomes (18)

  1. Occurrence of arrhythmia

    Incidence rates of participants with arrhythmia (new onset)

    Measured: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)

  2. New or worsening heart failure due to systolic dysfunction

    Symptomatic left ventricular ejection fraction (LVEF) <50%. European Participants only

    Measured: Baseline and up to 18 months

  3. Proportion of participants with a resting or provoked peak left ventricular outflow tract (LVOT) gradient below 50 mmHG

    European participants only

    Measured: Baseline and up to 18 months

  4. Proportion of participants with a resting or provoked peak left ventricular outflow tract (LVOT) gradient below 30 mmHG

    European participants only

    Measured: Baseline and up to 18 months

  5. Occurrence of Major Adverse Cardiovascular Events (MACE)

    A composite endpoint consisting of non-fatal acute Myocardial Infarction (MI), stroke, hospitalization due to Heart Failure (HF) and Cardiovascular (CV) mortality. United States participants only.

    Measured: Up to 5 Years

  6. Occurrence of non-fatal acute Myocardial Infarction (MI)

    United States participants only

    Measured: Up to 5 Years

  7. Occurrence of Stroke

    United States participants only

    Measured: Up to 5 Years

  8. Occurrence of hospitalization due to heart failure

    Measured: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)

  9. Occurrence of cardiovascular mortality

    United States participants only

    Measured: Up to 5 Years

  10. Occurrence of all-cause mortality

    Measured: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)

  11. Evaluation of functional responses: New York Heart Association (NYHA) function class

    Percentage of Participants Whose NYHA Class Changes

    Measured: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)

  12. Evaluation of functional responses: Left Ventricular Outflow Tract (LVOT) gradient

    Mean Change From Baseline in LVOT Gradients At Rest and Provoked

    Measured: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)

  13. Evaluation of functional responses: LVEF

    Mean Change from Baseline in LVEF

    Measured: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)

  14. Evaluation of patient reported outcome measure: Kansas City Cardiomyopathy Questionnaire 23 (KCCQ-23)

    The KCCQ-23 is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. United States participants only

    Measured: Baseline, and up to 5 Years

  15. Evaluation of patient reported outcome measure: EuroQol Five Dimensions Questionnaire (5-level) (EQ-5D-5L): Health Utility Index

    The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L health utility index and EQ Visual Analog Scale (VAS). EQ-5D-5L health utility index is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participants select an answer for each of the 5 dimensions that best matches his/her health "today". Responses are used to generate a weighted summary index, which ranges from 0 to 1.00. A higher score indicates better health and positive changes from baseline indicate improvement of health. United States participants only

    Measured: Baseline, and up to 5 Years

  16. Evaluation of patient reported outcome measure: EQ-5D-5L: VAS

    The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and VAS.

    The VAS self-rating records the participant's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status. United States participants only

    Measured: Baseline, and up to 5 Years

  17. Evaluation of biomarkers of response: NT-proBNP

    Change From Baseline in Serum concentration of NT-proBNP. United States participants only

    Measured: Baseline, and up to 5 Years

  18. Evaluation of biomarkers of response: Cardiac troponin

    Change From Baseline in Serum Concentration of Cardiac Troponins. United States participants only

    Measured: Baseline, and up to 5 Years

Timeline

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

  1. First posted5 Aug 2022
  2. Study start16 Aug 2022
  3. Primary completion17 Aug 2029 (estimated)
  4. Study completion17 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,700 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05489705
Sponsor's protocol ID
CV027-012
Acronym
DISCOVER-HCM
Status last verified
Aug 2026
First submitted
3 Aug 2022
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 101 sites in 9 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 13 inclusion and 12 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, Spain, Austria, France, Germany and 4 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.

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 BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of new or worsening heart failure due to systolic dysfunction among participants with symptomatic obstructive HCM during periods of exposure to mavacamten and other oHCM treatment (time frame: Up to 5 Years). 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 NCT05489705.

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 19 Aug 2026.

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