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NCT06122779Active, not recruitingPhase 2

Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
227 (actual)
First submitted
3 Nov 2023
Start date
7 Nov 2023
Primary completion date
14 Dec 2026
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT06122779
EU CT number
2023-505919-21-00
EudraCT number
2023-505919-21

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 227
  • From 7 Nov 2023 to the primary completion date, 14 Dec 2026
  • 88 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.

Other

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • \- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.

Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (88)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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Buenos AiresArgentinaUnknown status
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Ciudad del Libertador General San MartinArgentinaUnknown status
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CórdobaArgentinaUnknown status
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CórdobaArgentinaUnknown status
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CórdobaArgentinaUnknown status
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RosarioArgentinaUnknown status
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SaltaArgentinaUnknown status
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San Miguel de TucumánArgentinaUnknown status
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Santa FeArgentinaUnknown status
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ZárateArgentinaUnknown status
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HamiltonCanadaUnknown status
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TorontoCanadaUnknown status
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BeijingChinaUnknown status
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ChangshaChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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LuoyangChinaUnknown status
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
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BristolUnited KingdomUnknown status
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DundeeUnited KingdomUnknown status
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HarrowUnited KingdomUnknown status
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LeedsUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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North ShieldsUnited KingdomUnknown status
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OxfordUnited KingdomUnknown status
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Stockton-on-TeesUnited KingdomUnknown status
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WolverhamptonUnited KingdomUnknown status
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BeershebaIsraelUnknown status
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Be’er Ya‘aqovIsraelUnknown status
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HaifaIsraelUnknown status
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JerusalemIsraelUnknown status
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JerusalemIsraelUnknown status
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Petah TikvaIsraelUnknown status
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RehovotIsraelUnknown status
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SafedIsraelUnknown status
Azienda Ospedaliera Papa Giovanni XXIII
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BergamoItalyCompleted
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyCompleted
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyCompleted
Fondazione Toscana Gabriele Monasterio
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PisaItalyCompleted
IRCCS Policlinico San Donato
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San Donato MilaneseItalyCompleted
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Himeji-ShiJapanUnknown status
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KanazawaJapanUnknown status
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KishiwadaJapanUnknown status
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OkayamaJapanUnknown status
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Takatsuki-ShiJapanUnknown status
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DaeguSouth KoreaUnknown status
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DaejeonSouth KoreaUnknown status
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GwangjuSouth KoreaUnknown status
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JungguSouth KoreaUnknown status
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PusanSouth KoreaUnknown status
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SeongnamSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Clinical Trials Umed Sp. z o.o.
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LodzPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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LublinPolandCompleted
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AbingtonUnited StatesUnknown status
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AlbanyUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BirminghamUnited StatesUnknown status
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BrooklynUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DurhamUnited StatesUnknown status
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HackensackUnited StatesUnknown status
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Hazel CrestUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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IndianapolisUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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LakewoodUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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Oklahoma CityUnited StatesUnknown status
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RochesterUnited StatesUnknown status
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RochesterUnited StatesUnknown status
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RosedaleUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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TullahomaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.