## Protocol Section
### Identification Module
**NCT ID:** NCT06122779

**Acronym:** AURORA-HFpEF

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** CV029-1001
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
#### Secondary ID Infos
**ID:** 2023-505919-21
**Type:** EUDRACT_NUMBER
**Domain:** WHO
**ID:** U1111-1292-8451
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-01-22

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01-22

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-07

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2023-11-08
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-03
**Study First Submit QC Date:** 2023-11-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Heart Failure

**Keywords:**

- BMS-986435

- MYK-224

- Pharmacokinetics

- Pharmacodynamics

- Safety

- HFpEF

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 48

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BMS-986435

**Label:** BMS-986435

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BMS-986435

**Description:** Specified dose on specified days

**Name:** BMS-986435

**Other Names:**

- MYK-224

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Specified dose on specified days

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of treatment emergent adverse events (TEAEs)

**Time Frame:** Up to approximately 15 weeks

**Measure:** Incidence of serious adverse events (SAEs)

**Time Frame:** Up to approximately 15 weeks

**Measure:** Incidence of AEs leading to treatment discontinuation

**Time Frame:** Up to approximately 10 weeks

#### Secondary Outcomes

**Measure:** Summary of plasma concentrations of MYK-224

**Time Frame:** Up to approximately 15 weeks

### Eligibility Module

**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.

**Maximum Age:** 90 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Clinical.Trials@bms.com

**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com

**Phone:** 855-907-3286

**Role:** CONTACT

**Contact 2:**

**Name:** First line of the email MUST contain NCT # and Site #.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Birmingham

**Contacts:**

***Contact 1:***

- **Name:** Pankaj Arora, Site 0002

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Alabama at Birmingham

**State:** Alabama

**Status:** RECRUITING

**Zip:** 35233

**Location 2:**

**City:** Miami

**Contacts:**

***Contact 1:***

- **Name:** Sander Fernandez, Site 0003

- **Role:** CONTACT

**Country:** United States

**Facility:** Infinite Clinical Research

**State:** Florida

**Status:** RECRUITING

**Zip:** 33133-4223

**Location 3:**

**City:** Atlanta

**Contacts:**

***Contact 1:***

- **Name:** Alanna Morris, Site 0014

- **Role:** CONTACT

**Country:** United States

**Facility:** Emory Heart and Vascular Center

**State:** Georgia

**Status:** NOT_YET_RECRUITING

**Zip:** 30322-1013

**Location 4:**

**City:** Atlanta

**Country:** United States

**Facility:** Local Institution - 0048

**State:** Georgia

**Status:** WITHDRAWN

**Zip:** 30322-1013

**Location 5:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Name:** Ravi B Patel, Site 0004

- **Role:** CONTACT

**Country:** United States

**Facility:** Bluhm Cardiovascular Institute of Northwestern

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60611-5969

**Location 6:**

**City:** Hazel Crest

**Contacts:**

***Contact 1:***

- **Name:** Suhail Khadra, Site 0005

- **Phone:** 708-798-8522

- **Role:** CONTACT

**Country:** United States

**Facility:** Chicago Medical Research, LLC

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60429-2196

**Location 7:**

**City:** Indianapolis

**Contacts:**

***Contact 1:***

- **Name:** Site 0029

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0029

**State:** Indiana

**Status:** NOT_YET_RECRUITING

**Zip:** 46260-1992

**Location 8:**

**City:** Indianapolis

**Country:** United States

**Facility:** Local Institution - 0045

**State:** Indiana

**Status:** WITHDRAWN

**Zip:** 46260-1992

**Location 9:**

**City:** Saint Louis

**Contacts:**

***Contact 1:***

- **Name:** Harvey Serota, Site 0028

- **Phone:** 314-741-0911

- **Role:** CONTACT

**Country:** United States

**Facility:** St. Louis Heart and Vascular

**State:** Missouri

**Status:** RECRUITING

**Zip:** 63136-6111

**Location 10:**

**City:** Saint Louis

**Country:** United States

**Facility:** Local Institution - 0043

**State:** Missouri

**Status:** WITHDRAWN

**Zip:** 63136

**Location 11:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Name:** Parag Goyal, Site 0008

- **Role:** CONTACT

**Country:** United States

**Facility:** Weill Cornell Medicine

**State:** New York

**Status:** RECRUITING

**Zip:** 10065-4805

**Location 12:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Local Institution - 0041

**State:** Oklahoma

**Status:** WITHDRAWN

**Zip:** 73135-2607

**Location 13:**

**City:** Oklahoma City

**Contacts:**

***Contact 1:***

- **Name:** Naeem Tahirkheli, Site 0016

- **Phone:** 405-628-6865

- **Role:** CONTACT

**Country:** United States

**Facility:** South Oklahoma Heart Research

**State:** Oklahoma

**Status:** RECRUITING

**Zip:** 73135-2607

**Location 14:**

**City:** Tullahoma

**Contacts:**

***Contact 1:***

- **Name:** Dinesh Gupta, Site 0001

- **Phone:** 931-461-2663

- **Role:** CONTACT

**Country:** United States

**Facility:** Tennessee Center for Clinical Trials

**State:** Tennessee

**Status:** RECRUITING

**Zip:** 37388-8260

**Location 15:**

**City:** Dallas

**Contacts:**

***Contact 1:***

- **Name:** Ambarish Pandey, Site 0036

- **Phone:** 214-645-8000

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Texas Southwestern Medical Center

**State:** Texas

**Status:** RECRUITING

**Zip:** 75390

**Location 16:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Name:** Amin Karim, Site 0015

- **Phone:** 281-944-3610

- **Role:** CONTACT

**Country:** United States

**Facility:** Angiocardiac Care of Texas - PA - PPDS

**State:** Texas

**Status:** RECRUITING

**Zip:** 77025-5253

**Location 17:**

**City:** Houston

**Country:** United States

**Facility:** Local Institution - 0051

**State:** Texas

**Status:** WITHDRAWN

**Zip:** 77025-5253

**Location 18:**

**City:** Toronto

**Contacts:**

***Contact 1:***

- **Name:** Gordon Moe, Site 0037

- **Phone:** 4168645319

- **Role:** CONTACT

**Country:** Canada

**Facility:** Medicus MFC Inc.

**State:** Ontario

**Status:** RECRUITING

**Zip:** M4P 1E4

**Location 19:**

**City:** Toronto

**Contacts:**

***Contact 1:***

- **Name:** Site 0030

- **Role:** CONTACT

**Country:** Canada

**Facility:** Local Institution - 0030

**State:** Ontario

**Status:** NOT_YET_RECRUITING

**Zip:** M5S 1B2

**Location 20:**

**City:** Toronto

**Country:** Canada

**Facility:** Local Institution - 0040

**State:** Ontario

**Status:** WITHDRAWN

**Zip:** M5S 1B2

**Location 21:**

**City:** Trois-Rivieres

**Contacts:**

***Contact 1:***

- **Name:** Site 0035

- **Role:** CONTACT

**Country:** Canada

**Facility:** Local Institution - 0035

**State:** Quebec

**Status:** NOT_YET_RECRUITING

**Zip:** G9A 1Y1

**Location 22:**

**City:** Napoli

**Contacts:**

***Contact 1:***

- **Name:** Site 0019

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0019

**State:** Campania

**Status:** NOT_YET_RECRUITING

**Zip:** 80131

**Location 23:**

**City:** Melegnano

**Contacts:**

***Contact 1:***

- **Name:** Site 0022

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0022

**State:** Lombardia

**Status:** NOT_YET_RECRUITING

**Zip:** 20077

**Location 24:**

**City:** Milano

**Contacts:**

***Contact 1:***

- **Name:** Site 0023

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0023

**State:** Lombardia

**Status:** NOT_YET_RECRUITING

**Zip:** 20162

**Location 25:**

**City:** Milano

**Country:** Italy

**Facility:** Local Institution - 0033

**State:** Lombardia

**Status:** WITHDRAWN

**Zip:** 20162

**Location 26:**

**City:** San Donato Milanese

**Country:** Italy

**Facility:** Local Institution - 0050

**State:** Lombardia

**Status:** WITHDRAWN

**Zip:** 20097

**Location 27:**

**City:** Foggia

**Country:** Italy

**Facility:** Local Institution - 0027

**State:** Puglia

**Status:** WITHDRAWN

**Zip:** 71100

**Location 28:**

**City:** Foggia

**Contacts:**

***Contact 1:***

- **Name:** Site 0038

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0038

**State:** Puglia

**Status:** NOT_YET_RECRUITING

**Zip:** 71100

**Location 29:**

**City:** Massa

**Country:** Italy

**Facility:** Local Institution - 0052

**State:** Toscana

**Status:** WITHDRAWN

**Zip:** 54100

**Location 30:**

**City:** Pisa

**Contacts:**

***Contact 1:***

- **Name:** Site 0017

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0017

**State:** Toscana

**Status:** NOT_YET_RECRUITING

**Zip:** 56124

**Location 31:**

**City:** Bergamo

**Contacts:**

***Contact 1:***

- **Name:** Site 0009

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0009

**Status:** NOT_YET_RECRUITING

**Zip:** 24127

**Location 32:**

**City:** Lublin

**Contacts:**

***Contact 1:***

- **Name:** Site 0020

- **Role:** CONTACT

**Country:** Poland

**Facility:** Local Institution - 0020

**State:** Lubelskie

**Status:** NOT_YET_RECRUITING

**Zip:** 20-954

**Location 33:**

**City:** Lódz

**Contacts:**

***Contact 1:***

- **Name:** Site 0013

- **Role:** CONTACT

**Country:** Poland

**Facility:** Local Institution - 0013

**State:** Lódzkie

**Status:** NOT_YET_RECRUITING

**Zip:** 92-213

**Location 34:**

**City:** Bialystok

**Contacts:**

***Contact 1:***

- **Name:** Site 0031

- **Role:** CONTACT

**Country:** Poland

**Facility:** Local Institution - 0031

**State:** Podlaskie

**Status:** NOT_YET_RECRUITING

**Zip:** 15-276

**Location 35:**

**City:** Bialystok

**Country:** Poland

**Facility:** Local Institution - 0044

**State:** Podlaskie

**Status:** WITHDRAWN

**Zip:** 15-276

**Location 36:**

**City:** Krakow

**Country:** Poland

**Facility:** Local Institution - 0006

**Status:** WITHDRAWN

**Zip:** 30-082

**Location 37:**

**City:** Lublin

**Country:** Poland

**Facility:** Local Institution - 0049

**Status:** WITHDRAWN

**Zip:** 20-954

**Location 38:**

**City:** Oswiecim

**Country:** Poland

**Facility:** Local Institution - 0024

**Status:** WITHDRAWN

**Zip:** 51162

**Location 39:**

**City:** Hospitalet de Llobregat

**Contacts:**

***Contact 1:***

- **Name:** Josep Comin, Site 0012

- **Phone:** 34932483123

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario de Bellvitge

**State:** Barcelona

**Status:** RECRUITING

**Zip:** 08907

**Location 40:**

**City:** Majadahonda

**Contacts:**

***Contact 1:***

- **Name:** Pablo García Pavia, Site 0025

- **Phone:** +34911917297

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario Puerta de Hierro - Majadahonda

**State:** Madrid

**Status:** RECRUITING

**Zip:** 28222

**Location 41:**

**City:** Majadahonda

**Country:** Spain

**Facility:** Local Institution - 0047

**State:** Madrid

**Status:** WITHDRAWN

**Zip:** 28222

**Location 42:**

**City:** El Palmar

**Contacts:**

***Contact 1:***

- **Name:** Domingo Pascual-Figal, Site 0021

- **Phone:** +34968369662

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario Virgen de La Arrixaca

**State:** Murcia

**Status:** RECRUITING

**Zip:** 30120

**Location 43:**

**City:** El Palmar

**Country:** Spain

**Facility:** Local Institution - 0039

**State:** Murcia

**Status:** WITHDRAWN

**Zip:** 30120

**Location 44:**

**City:** Malaga

**Contacts:**

***Contact 1:***

- **Name:** José Manuel García Pinilla, Site 0032

- **Phone:** +34951032349

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario Virgen de la Victoria

**State:** Málaga

**Status:** RECRUITING

**Zip:** 29010

**Location 45:**

**City:** Malaga

**Country:** Spain

**Facility:** Local Institution - 0042

**State:** Málaga

**Status:** WITHDRAWN

**Zip:** 29010

**Location 46:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Name:** Pau Llacer Iborra, Site 0026

- **Phone:** 34913368923

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario Ramon y Cajal

**Status:** RECRUITING

**Zip:** 28034

**Location 47:**

**City:** Madrid

**Country:** Spain

**Facility:** Local Institution - 0034

**Status:** WITHDRAWN

**Zip:** 28034

**Location 48:**

**City:** Sevilla

**Contacts:**

***Contact 1:***

- **Name:** Antonio Reyes Dominguez, Site 0018

- **Phone:** 34955015777

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Nuestra Señora de Valme

**Status:** RECRUITING

**Zip:** 41014

**Location 49:**

**City:** Sevilla

**Country:** Spain

**Facility:** Local Institution - 0046

**Status:** WITHDRAWN

**Zip:** 41014

**Location 50:**

**City:** Valencia

**Contacts:**

***Contact 1:***

- **Name:** Julio Nuñez Villota, Site 0010

- **Phone:** +34961973520

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Clinico Universitario de Valencia

**Status:** RECRUITING

**Zip:** 46010

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** See Plan Description

**Description:** 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/disclosurecommitment.html

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** See Plan Description

**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

### References Module

#### See Also Links

**Label:** BMS Clinical Trial Information

**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

**Label:** BMS Clinical Trial Patient Recruiting

**URL:** https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06122779

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M258342

- Name: Sulconazole

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
