Acute Decompensated Heart Failure Clinical Trial
Official title:
A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure
| Verified date | August 2022 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | July 19, 2021 |
| Est. primary completion date | July 19, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants currently hospitalized for acute decompensated heart failure (ADHF) - Participants 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 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 Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0007 | Alberdi | Cordoba |
| Argentina | Local Institution | Ciudad Autónoma de Buenos Aires | Distrito Federal |
| Argentina | Local Institution - 0009 | Ciudad de Buenos Aires | Buenos Aires |
| Argentina | Local Institution - 0025 | Cordoba | |
| Argentina | Local Institution - 0028 | Cordoba | Provincia DE Cordoba |
| Argentina | Local Institution - 0010 | Córdoba | Cordoba |
| Czechia | Local Institution - 0020 | Praha 2 | |
| Czechia | Nemocnice Slany-Interna - kardiologicka ambulance | Slany | |
| Greece | Local Institution - 0011 | Athens | |
| Greece | Local Institution - 0022 | Athens | |
| Israel | Local Institution | Jerusalem | |
| Israel | Local Institution | Petah Tikva | |
| Israel | Local Institution - 0014 | Tel Aviv | Tell Abib |
| Poland | Local Institution - 0034 | Bialystok | |
| Poland | Local Institution - 0030 | Wrocaw | |
| Poland | Local Institution - 0027 | Wroclaw | |
| United Kingdom | Local Institution | Edinburgh | |
| United Kingdom | Local Institution | Swindon |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Argentina, Czechia, Greece, Israel, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing Clinically Relevant Hypotension | Clinically Relevant Hypotension is defined as occurrence of any of the following:
Supine Systolic Blood Pressure (SBP) <85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension Supine SBP <90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc). |
From first dose to 30 days following first dose | |
| Secondary | Maximum Observed Serum Concentration (Cmax) | Day 1 and Day 5 of study treatment | ||
| Secondary | Time of Maximum Observed Serum Concentration (Tmax) | Day 1 and Day 5 of study treatment | ||
| Secondary | Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) | Day 1 and Day 5 of study treatment | ||
| Secondary | Trough Concentration (Ctrough) | Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available) |
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