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Heart FailurePhase 2AURORA-HFpEFNCT06122779

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 2 study testing BMS-986435 in people with Heart Failure, run by Bristol-Myers Squibb at 86 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Heart Failure
What is being tested?
BMS-986435
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
227 participants
Where
86 sitesin 11 countries
Study dates
7 Nov 2023to 14 Dec 2026
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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

86 sites in 11 countries.

86 sites in 11 countries

United States23 sites

  • Local Institution - 0078

    Abington, Pennsylvania, 19001

  • Local Institution - 0070

    Albany, New York, 12211

  • Local Institution - 0104

    Austin, Texas, 78756-4080

  • Local Institution - 0002

    Birmingham, Alabama, 35233

  • Local Institution - 0105

    Brooklyn, New York, 11215

  • Local Institution - 0004

    Chicago, Illinois, 60611-5969

  • Local Institution - 0036

    Dallas, Texas, 75390

  • Local Institution - 0095

    Durham, North Carolina, 27710-4000

  • Local Institution - 0117

    Hackensack, New Jersey, 07601-1915

  • Local Institution - 0005

    Hazel Crest, Illinois, 60429-2196

  • Local Institution - 0015

    Houston, Texas, 77025-5253

  • Local Institution - 0029

    Indianapolis, Indiana, 46260-1992

  • Local Institution - 0077

    Jacksonville, Florida, 32204-4748

  • Local Institution - 0096

    Lakewood, Colorado, 80228-1710

  • Local Institution - 0003

    Miami, Florida, 33133-4223

  • Local Institution - 0099

    Miami, Florida, 33136-2107

  • Local Institution - 0008

    New York, New York, 10065-4805

  • Local Institution - 0016

    Oklahoma City, Oklahoma, 73135-2607

  • Local Institution - 0059

    Rochester, New York, 14618-2668

  • Local Institution - 0076

    Rochester, New York, 14621

  • Local Institution - 0094

    Rosedale, New York, 11422-1320

  • Local Institution - 0028

    St Louis, Missouri, 63136-6111

  • Local Institution - 0001

    Tullahoma, Tennessee, 37388-8260

Other trials in United States

Argentina11 sites

  • Local Institution - 0060

    Buenos Aires, 1407

  • Local Institution - 0067

    Buenos Aires, C1431FWO

  • Local Institution - 0054

    Ciudad del Libertador General San Martin, Buenos Aires, B1650BNB

  • Local Institution - 0090

    Córdoba, Córdoba Province, 5000

  • Local Institution - 0053

    Córdoba, Córdoba Province, X5003DCE

  • Local Institution - 0074

    Córdoba, X5000AOQ

  • Local Institution - 0073

    Rosario, Santa Fe Province, 2000

  • Local Institution - 0069

    Salta, A4406BPF

  • Local Institution - 0061

    San Miguel de Tucumán, Tucumán Province, T4000IAP

  • Local Institution - 0102

    Santa Fe, S3000FWO

  • Local Institution - 0115

    Zárate, Buenos Aires, B2800DGH

Other trials in Argentina

South Korea10 sites

  • Local Institution - 0088

    Daegu, 42601

  • Local Institution - 0084

    Daejeon, Daejeon Gwang'yeogsi, 35015

  • Local Institution - 0083

    Gwangju, Gwangju Gwang'yeogsi, 61469

  • Local Institution - 0056

    Junggu, Incheon Gwang'yeogsi, 22332

  • Local Institution - 0086

    Pusan, Busan Gwangyeogsi, 49241

  • Local Institution - 0098

    Seongnam, Gyeonggido, 13620

  • Local Institution - 0081

    Seoul, Seoul Teugbyeolsi, 03080

  • Local Institution - 0085

    Seoul, Seoul Teugbyeolsi, 03722

  • Local Institution - 0114

    Seoul, Seoul Teugbyeolsi, 06351

  • Local Institution - 0055

    Seoul, Seoul Teugbyeolsi, 06591

Other trials in South Korea

United Kingdom9 sites

  • Local Institution - 0101

    Bristol, BS2 8HW

  • Local Institution - 0097

    Dundee, DD1 9SY

  • Local Institution - 0063

    Harrow, Greater London, HA1 3UJ

  • Local Institution - 0072

    Leeds, Yorkshire, LS1 3EX

  • Local Institution - 0075

    London, SE1 7EH

  • Local Institution - 0071

    North Shields, Northumberland, NE29 8NH

  • Local Institution - 0062

    Oxford, OX3 9DU

  • Local Institution - 0065

    Stockton-on-Tees, TS19 8PE

  • Local Institution - 0064

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Israel8 sites

  • Local Institution - 0112

    Be’er Ya‘aqov, 7033001

  • Local Institution - 0111

    Beersheba, 84101

  • Local Institution - 0108

    Haifa, 3109601

  • Local Institution - 0109

    Jerusalem, Jerusalem, 90000

  • Local Institution - 0113

    Jerusalem, 9103102

  • Local Institution - 0110

    Petah Tikva, 49100

  • Local Institution - 0106

    Rehovot, 76100

  • Local Institution - 0116

    Safed, 1311001

Other trials in Israel

Spain7 sites

  • Local Institution - 0021

    El Palmar, Murcia, 30120

  • Local Institution - 0012

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Local Institution - 0026

    Madrid, 28034

  • Local Institution - 0025

    Majadahonda, Madrid, 28222

  • Local Institution - 0032

    Málaga, 29010

  • Local Institution - 0018

    Seville, 41014

  • Local Institution - 0010

    Valencia, 46010

Other trials in Spain

China5 sites

  • Local Institution - 0089

    Beijing, Beijing Municipality, 100730

  • Local Institution - 0079

    Changsha, Hunan, 410011

  • Local Institution - 0087

    Guangzhou, Guangdong, 510120

  • Local Institution - 0082

    Hangzhou, Zhejiang, 310009

  • Local Institution - 0080

    Luoyang, Henan, 471003

Other trials in China

Japan5 sites

  • Local Institution - 0092

    Himeji-Shi, Hyōgo, 672-8044

  • Local Institution - 0100

    Kanazawa, Ishikawa-ken, 920-8650

  • Local Institution - 0093

    Kishiwada, Osaka, 596-0042

  • Local Institution - 0091

    Okayama, Okayama-ken, 702-8055

  • Local Institution - 0103

    Takatsuki-Shi, Osaka, 569-1045

Other trials in Japan

Italy4 sites

  • Local Institution - 0009

    Bergamo, 24127

  • Local Institution - 0019

    Naples, Campania, 80131

  • Local Institution - 0017

    Pisa, Tuscany, 56126

  • Local Institution - 0022

    San Donato Milanese, Lombardy, 20097

Other trials in Italy

Canada2 sites

  • Local Institution - 0007

    Hamilton, Ontario, L8L 2X2

  • Local Institution - 0037

    Toronto, Ontario, M4P 1E4

Other trials in Canada

Poland2 sites

  • Local Institution - 0031

    Bialystok, Podlaskie Voivodeship, 15-276

  • Local Institution - 0013

    Lódz, Lódzkie, 92-213

Other trials in Poland

About this study

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)

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).

Conditions
Heart Failure
Being tested
BMS-986435, Placebo
Keywords
BMS-986435, MYK-224, Pharmacokinetics, Pharmacodynamics, Safety, HFpEF
Medical subject headings
Heart Failure

What participants receive

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

  • BMS-986435Drug

    Also called MYK-224

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT06122779
Study groupRoleWhat they receive
BMS-986435ExperimentalNot described
Receives: Drug: BMS-986435
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. Incidence of treatment emergent adverse events (TEAEs)

    Measured: Up to approximately 24 weeks

  2. Incidence of serious adverse events (SAEs)

    Measured: Up to approximately 24 weeks

  3. Incidence of AEs leading to treatment discontinuation

    Measured: Up to approximately 20 weeks

Secondary outcomes (1)

  1. Summary of plasma concentrations of MYK-224

    Measured: Up to approximately 20 weeks

Timeline

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

  1. First posted8 Nov 2023
  2. Study start7 Nov 2023
  3. Primary completion14 Dec 2026 (estimated)
  4. Study completion14 Dec 2026 (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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06122779
Sponsor's protocol ID
CV029-1001
Other IDs
2023-505919-21, U1111-1292-8451, 2023
Acronym
AURORA-HFpEF
Status last verified
Jul 2026
First submitted
3 Nov 2023
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986435 in people with Heart Failure, run by Bristol-Myers Squibb at 86 sites in 11 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Argentina, South Korea, United Kingdom, Israel and 6 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?

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?

Incidence of treatment emergent adverse events (TEAEs) (time frame: Up to approximately 24 weeks). The study lists 3 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 NCT06122779.

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 30 Jul 2026.

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