Clinical trial NCT06122779: Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Heart Failure
Keywords: BMS-986435
MYK-224
Pharmacokinetics
Pharmacodynamics
Safety
HFpEF
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 198
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

* 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 protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: Up to approximately 24 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to approximately 24 weeks
measure: Incidence of AEs leading to treatment discontinuation
timeFrame: Up to approximately 20 weeks
Secondary outcomes:
measure: Summary of plasma concentrations of MYK-224
timeFrame: Up to approximately 20 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Lakewood
country: United States
facility: Local Institution - 0096
state: Colorado
city: Jacksonville
country: United States
facility: Local Institution - 0077
state: Florida
city: Miami
country: United States
facility: Infinite Clinical Research
state: Florida
city: Miami
country: United States
facility: Local Institution - 0099
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0014
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0048
state: Georgia
city: Chicago
country: United States
facility: Bluhm Cardiovascular Institute of Northwestern
state: Illinois
city: Hazel Crest
country: United States
facility: Chicago Medical Research, LLC
state: Illinois
city: Indianapolis
country: United States
facility: Ascension Medical Group St. Vincent - Indianapolis Heart Care
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution - 0045
state: Indiana
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Saint Louis
country: United States
facility: Local Institution - 0043
state: Missouri
city: Albany
country: United States
facility: Local Institution - 0070
state: New York
city: Brooklyn
country: United States
facility: Local Institution - 0105
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Rochester
country: United States
facility: Local Institution - 0059
state: New York
city: Rochester
country: United States
facility: Local Institution - 0076
state: New York
city: Rosedale
country: United States
facility: Local Institution - 0094
state: New York
city: Durham
country: United States
facility: Local Institution - 0095
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution - 0058
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 0041
state: Oklahoma
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research
state: Oklahoma
city: Abington
country: United States
facility: Local Institution - 0078
state: Pennsylvania
city: Tullahoma
country: United States
facility: Tennessee Center for Clinical Trials
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0104
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Angiocardiac Care of Texas - PA - PPDS
state: Texas
city: Houston
country: United States
facility: Local Institution - 0051
state: Texas
city: Falls Church
country: United States
facility: Local Institution - 0066
state: Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0060
state: Buenos Aires
city: General San Martín
country: Argentina
facility: Local Institution - 0054
state: Buenos Aires
city: Zárate
country: Argentina
facility: Local Institution - 0107
state: Buenos Aires
city: Zárate
country: Argentina
facility: Local Institution - 0115
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Local Institution - 0090
state: Cordoba
city: Córdoba
country: Argentina
facility: Local Institution - 0053
state: Cordoba
city: Rosario
country: Argentina
facility: Local Institution - 0073
state: Santa FE
city: San Miguel De Tucumán
country: Argentina
facility: Local Institution - 0061
state: Tucuman
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0067
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0068
city: Córdoba
country: Argentina
facility: Local Institution - 0074
city: Salta
country: Argentina
facility: Local Institution - 0069
city: Santa Fe
country: Argentina
facility: Local Institution - 0102
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Medicus MFC Inc.
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0030
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0040
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0011
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Local Institution - 0035
state: Quebec
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: Local Institution - 0087
state: Guangdong
city: Luoyang
country: China
facility: Local Institution - 0080
state: Henan
city: Changsha
country: China
facility: Local Institution - 0079
state: Hunan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Jerusalem
country: Israel
facility: Local Institution - 0109
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Local Institution - 0113
state: Yerushalayim
city: Be'er - Ya'akov
country: Israel
facility: Local Institution - 0112
city: Be'er Sheva
country: Israel
facility: Local Institution - 0111
city: Haifa
country: Israel
facility: Local Institution - 0108
city: Petah Tikva
country: Israel
facility: Local Institution - 0110
city: Rehovot
country: Israel
facility: Local Institution - 0106
city: Napoli
country: Italy
facility: Local Institution - 0019
state: Campania
city: Milano
country: Italy
facility: Local Institution - 0023
state: Lombardia
city: Milano
country: Italy
facility: Local Institution - 0033
state: Lombardia
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Lombardia
city: San Donato Milanese
country: Italy
facility: Local Institution - 0050
state: Lombardia
city: Foggia
country: Italy
facility: Local Institution - 0027
state: Puglia
city: Foggia
country: Italy
facility: Local Institution - 0038
state: Puglia
city: Massa
country: Italy
facility: Local Institution - 0052
state: Toscana
city: Bergamo
country: Italy
facility: Local Institution - 0009
city: Pisa
country: Italy
facility: Local Institution - 0017
city: Himeji-Shi
country: Japan
facility: Local Institution - 0092
state: Hyogo
city: Kanazawa
country: Japan
facility: Local Institution - 0100
state: Ishikawa
city: Okayama-Shi
country: Japan
facility: Local Institution - 0091
state: Okayama
city: Kishiwada
country: Japan
facility: Local Institution - 0093
state: Osaka
city: Takatsuki-Shi
country: Japan
facility: Local Institution - 0103
state: Osaka
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0088
state: Daegu Gwang'yeogsi
city: Daejeon
country: Korea, Republic of
facility: Local Institution - 0084
state: Daejeon Gwang'yeogsi
city: Gwangju
country: Korea, Republic of
facility: Local Institution - 0083
state: Gwangju Gwang'yeogsi
city: Jung-gu
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon Gwang'yeogsi
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0085
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0114
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0055
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Local Institution - 0086
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0098
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0081
city: Lódz
country: Poland
facility: Clinical Trials UMED Sp. z o.o.
state: Lódzkie
city: Bialystok
country: Poland
facility: Local Institution - 0031
state: Podlaskie
city: Bialystok
country: Poland
facility: Local Institution - 0044
state: Podlaskie
city: Lublin
country: Poland
facility: Local Institution - 0020
state: Woj. Lubelskie
city: Lublin
country: Poland
facility: Local Institution - 0049
state: Woj. Lubelskie
city: Krakow
country: Poland
facility: Local Institution - 0006
city: Oswiecim
country: Poland
facility: Local Institution - 0024
city: Hospitalet de Llobregat
country: Spain
facility: Local Institution - 0012
state: Barcelona
city: Majadahonda
country: Spain
facility: Local Institution - 0025
state: Madrid
city: Majadahonda
country: Spain
facility: Local Institution - 0047
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
state: Murcia
city: El Palmar
country: Spain
facility: Local Institution - 0039
state: Murcia
city: Malaga
country: Spain
facility: Local Institution - 0042
state: Málaga
city: Madrid
country: Spain
facility: Local Institution - 0026
city: Madrid
country: Spain
facility: Local Institution - 0034
city: Malaga
country: Spain
facility: Local Institution - 0032
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
city: Sevilla
country: Spain
facility: Local Institution - 0046
city: Valencia
country: Spain
facility: Local Institution - 0010
city: Harrow
country: United Kingdom
facility: Local Institution - 0063
state: Greater London
city: North Shields
country: United Kingdom
facility: Local Institution - 0071
state: Northumberland
city: Oxford
country: United Kingdom
facility: Local Institution - 0062
state: Oxfordshire
city: Leeds
country: United Kingdom
facility: Local Institution - 0072
state: Yorkshire
city: Sheffield
country: United Kingdom
facility: Local Institution - 0057
state: Yorkshire
city: Bristol
country: United Kingdom
facility: Local Institution - 0101
city: Dundee
country: United Kingdom
facility: Local Institution - 0097
city: London
country: United Kingdom
facility: Local Institution - 0075
city: Stockton-On-Tees
country: United Kingdom
facility: Local Institution - 0065
city: Wolverhampton
country: United Kingdom
facility: Local Institution - 0064
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: