Clinical Trials Register (2024)

E.1 Medical condition or disease under investigationE.1.1Medical condition(s) being investigated

Heart failure

E.1.1.1Medical condition in easily understood language

Heart failure

E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]MedDRA ClassificationE.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLGT
E.1.2	Classification code	10019280
E.1.2	Term	Heart failures
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3Condition being studied is a rare disease No E.2 Objective of the trialE.2.1Main objective of the trial

To establish safety & tolerability of BMS-986259 when initiated inhospital in stabilized participants post-ADHF.

E.2.2Secondary objectives of the trial

To evaluate serum PK parameters in participants with HF

E.2.3Trial contains a sub-study No E.3Principal inclusion criteria

-Patients currently hospitalized for acute decompensated heart failure (ADHF)
-Patients must be hemodynamically stable, as assessed by the investigator
-Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
-Women participants must have documented proof that they are not of childbearing potential
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and is not a WOCBP.
- No healthy patients, only subjects

E.4Principal exclusion criteria

-Acute cardiovascular condition other than heart failure (HF) decompensation
-Cardiogenic shock at presentation to emergency room (ER) or at any time before randomization
-Recipient of ventricular assist devices or use of any cardiac extracorporeal devices, within 12 weeks of study randomization
-Participants with contraindications to vasodilator therapy such as restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis

E.5 End pointsE.5.1Primary end point(s)

Incidence of clinically relevant hypotension, defined as:
- Supine SBP =< 85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension
OR
- Supine SBP =< 90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension

E.5.1.1Timepoint(s) of evaluation of this end point

Up to 14 days

E.5.2Secondary end point(s)

1. Maximum observed plasma concentration (Cmax) - On day 5
2. Time of maximum observed plasma concentration (Tmax) - On day 5
3. Area under the concentrationtime curve in one dosing interval [AUC(TAU)] - On day 5
4. Concentration at 24 hours post-dose (C24) - On day 5
5. Incidence of Non-Serious Adverse Events - Up to 32 days
6. Incidence of Serious Adverse Events - Up to 70 days and up to 3 months for participants who develop Anti-Drug Antibody (ADA)
Incidence of clinically significant changes in vital signs of body temperature - Up to 22 days
7. Incidence of clinically significant changes in vital signs of respiratory rate - Up to 22 days
8. Incidence of clinically significant changes in vital signs of blood pressure - Up to 22 days
9. Incidence of clinically significant changes in vital signs of heart rate - Up to 22 days
10. Incidence of clinically significant changes in clinical laboratory tests of clinical chemistry - Up to 40 days
11. Incidence of clinically significant changes in clinical laboratory tests of hematology - Up to 40 days
12. Incidence of clinically significant changes in clinical laboratory tests of urinalysis - Up to 40 days
13. Incidence of clinically significant changes in electrocardiogram (ECG) parameters - Up to 22 days
14. Incidence of clinically significant changes from baseline in physical examination findings - Up to 22 days

E.5.2.1Timepoint(s) of evaluation of this end point

Endpoints from 1 to 4: On day 5
Endpoint 5: Up to 2 days
Endpoint 6: Up to 70 days and up to 3 months for participants who develop Anti-Drug Antibody (ADA)
Endpoints from 7 to 10 and from 14 to 15: Up to 22 days
Endpoints from 11 to 13: Up to 40 days

E.6 and E.7 Scope of the trialE.6Scope of the trialE.6.1Diagnosis Yes E.6.2Prophylaxis No E.6.3Therapy No E.6.4Safety Yes E.6.5Efficacy No E.6.6Pharmaco*kinetic Yes E.6.7Pharmacodynamic No E.6.8Bioequivalence No E.6.9Dose response No E.6.10Pharmacogenetic No E.6.11Pharmacogenomic No E.6.12Pharmacoeconomic No E.6.13Others Yes E.6.13.1Other scope of the trial description

Tolerability

E.7Trial type and phaseE.7.1Human pharmacology (Phase I) No E.7.1.1First administration to humans No E.7.1.2Bioequivalence study No E.7.1.3Other No E.7.1.3.1Other trial type descriptionE.7.2Therapeutic exploratory (Phase II) Yes E.7.3Therapeutic confirmatory (Phase III) No E.7.4Therapeutic use (Phase IV) No E.8 Design of the trialE.8.1Controlled Yes E.8.1.1Randomised Yes E.8.1.2Open No E.8.1.3Single blind No E.8.1.4Double blind Yes E.8.1.5Parallel group No E.8.1.6Cross over No E.8.1.7Other No E.8.2 Comparator of controlled trialE.8.2.1Other medicinal product(s) No E.8.2.2Placebo Yes E.8.2.3Other No E.8.2.4Number of treatment arms in the trial2E.8.3 The trial involves single site in the Member State concerned No E.8.4 The trial involves multiple sites in the Member State concerned Yes E.8.4.1Number of sites anticipated in Member State concerned4E.8.5The trial involves multiple Member States Yes E.8.5.1Number of sites anticipated in the EEA16E.8.6 Trial involving sites outside the EEAE.8.6.1Trial being conducted both within and outside the EEA Yes E.8.6.2Trial being conducted completely outside of the EEA No E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Czech Republic

Greece

Israel

Netherlands

Poland

United Kingdom

E.8.7Trial has a data monitoring committee No E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trialE.8.9.1In the Member State concerned years0E.8.9.1In the Member State concerned months11E.8.9.1In the Member State concerned days28E.8.9.2In all countries concerned by the trial years1E.8.9.2In all countries concerned by the trial months0E.8.9.2In all countries concerned by the trial days10