Heart Failure Clinical Trial
— AURORA-HFpEFOfficial 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).
| Status | Recruiting |
| Enrollment | 48 |
| Est. completion date | January 22, 2025 |
| Est. primary completion date | January 22, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 90 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution - 0030 | Toronto | Ontario |
| Canada | Local Institution - 0040 | Toronto | Ontario |
| Canada | Medicus MFC Inc. | Toronto | Ontario |
| Canada | Local Institution - 0035 | Trois-Rivieres | Quebec |
| Italy | Local Institution - 0009 | Bergamo | |
| Italy | Local Institution - 0027 | Foggia | Puglia |
| Italy | Local Institution - 0038 | Foggia | Puglia |
| Italy | Local Institution - 0052 | Massa | Toscana |
| Italy | Local Institution - 0022 | Melegnano | Lombardia |
| Italy | Local Institution - 0023 | Milano | Lombardia |
| Italy | Local Institution - 0033 | Milano | Lombardia |
| Italy | Azienda Ospedaliera Universitaria 'Federico II' | Napoli | Campania |
| Italy | Fondazione Toscana Gabriele Monasterio - Ospedale San Cataldo - CNR | Pisa | Toscana |
| Italy | Local Institution - 0050 | San Donato Milanese | Lombardia |
| Poland | Local Institution - 0044 | Bialystok | Podlaskie |
| Poland | Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Curie-Sklodowskiej 24a | Bialystok | Podlaskie |
| Poland | Local Institution - 0006 | Krakow | |
| Poland | Local Institution - 0013 | Lódz | Lódzkie |
| Poland | Local Institution - 0020 | Lublin | Woj. Lubelskie |
| Poland | Local Institution - 0049 | Lublin | Woj. Lubelskie |
| Poland | Local Institution - 0024 | Oswiecim | |
| Spain | Hospital Universitario Virgen de La Arrixaca | El Palmar | Murcia |
| Spain | Local Institution - 0039 | El Palmar | Murcia |
| Spain | Hospital Universitario de Bellvitge | Hospitalet de Llobregat | Barcelona |
| Spain | Hospital Universitario Ramon y Cajal | Madrid | |
| Spain | Local Institution - 0034 | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | Madrid |
| Spain | Local Institution - 0047 | Majadahonda | Madrid |
| Spain | Hospital Universitario Virgen de la Victoria | Malaga | Málaga |
| Spain | Local Institution - 0042 | Malaga | Málaga |
| Spain | Hospital Nuestra Señora de Valme | Sevilla | |
| Spain | Local Institution - 0046 | Sevilla | |
| Spain | Hospital Clinico Universitario de Valencia | Valencia | |
| United States | Emory Heart and Vascular Center | Atlanta | Georgia |
| United States | Local Institution - 0048 | Atlanta | Georgia |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Bluhm Cardiovascular Institute of Northwestern | Chicago | Illinois |
| United States | University of Texas Southwestern Medical Center | Dallas | Texas |
| United States | Chicago Medical Research, LLC | Hazel Crest | Illinois |
| United States | Angiocardiac Care of Texas - PA - PPDS | Houston | Texas |
| United States | Local Institution - 0051 | Houston | Texas |
| United States | Local Institution - 0029 | Indianapolis | Indiana |
| United States | Local Institution - 0045 | Indianapolis | Indiana |
| United States | Infinite Clinical Research | Miami | Florida |
| United States | Weill Cornell Medicine | New York | New York |
| United States | Local Institution - 0041 | Oklahoma City | Oklahoma |
| United States | South Oklahoma Heart Research | Oklahoma City | Oklahoma |
| United States | Local Institution - 0043 | Saint Louis | Missouri |
| United States | St. Louis Heart and Vascular | Saint Louis | Missouri |
| United States | Tennessee Center for Clinical Trials | Tullahoma | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Canada, Italy, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of treatment emergent adverse events (TEAEs) | Up to approximately 15 weeks | ||
| Primary | Incidence of serious adverse events (SAEs) | Up to approximately 15 weeks | ||
| Primary | Incidence of AEs leading to treatment discontinuation | Up to approximately 10 weeks | ||
| Secondary | Summary of plasma concentrations of MYK-224 | Up to approximately 15 weeks |
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