NL-OMON46654CompletedPhase 2
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Cross-over Phase 2 Study of Continuous 5-Hour Intravenous Infusions of BMS-986231 in Patients with Heart Failure and Impaired Systolic Function - BMS CV013-020
Bristol-Myers Squibb0 sites5 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 5
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •* Signed Written Informed Consent
- •* Age 18 years (or age of majority) or older
- •* Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less), as assessed by the echocardiographic corelab.
- •* Stable guideline directed therapy for heart failure (could include oral diuretics, ACEi, ARBs, ARNi, MRAs , and * blockers as tolerated), with no dose changes of these medications in the past 2 weeks
- •* Have screening values of NT pro-BNP * 125 pg/mL (15 pmol/L) or BNP * 35 pg/mL (10 pmol/L).
- •* In sinus rhythm at the start of the infusion
Exclusion Criteria
- •* Body weight < 45 kg or * 140 kg
- •* Low quality echocardiographic visualization windows and image acquisition
- •* Systolic blood pressure (SBP) < 110 mm Hg at screening or pre-randomization
- •* Heart rate < 50 beats per minute (bpm) or > 90 bpm at screening or pre-randomization
- •* Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial Flutter before start of the infusion
- •* Parmanent paced rhythm (VVI, DDD or BiV pacing)
- •* Ventricular assist device or prior heart transplant
- •* Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic or uncorrected severe valvular disease as defined by AHA/ACC/ESC criteria.
- •* (Note: A restrictive mitral inflow pattern is NOT exclusionary)
- •* Large post-MI Left Ventricular aneurisms
- •* Intra-cardiac thrombus
- •* Prior mitral valve repair, mitral or aortic prosthesis
- •* Treatment with oral phosphodiesterase type 5 (PDE5) inhibitor sildenafil, vardenafil or avanafil within 24 hours of study drug infusion or treated with tadalafil within 4 days of study drug infusion
- •* Hospitalized for acute decompensated heart failure in the previous month
- •* Hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening
- •* Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening
- •* NYHA Class IV symptoms of heart failure
- •* Treatment with intravenous inotropic therapy (dobutamine, milrinone, leveosimendan) in the previous month or planned treatment in the next 3 months.
- •* Current treatment with chronic oral, transdermal or sublingual nitrates, except at the discretion of the investigator and treating physician, nitrates could be temporarily interrupted. In which case, an
- •interruption of 3 days is required prior to start of study drug.
- •* Prior solid organ transplant
- •* Estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m2
- •* Have persistent abnormal serum electrolytes not resolved between screening and start of the study drug infusion, as defined by any of the following:
- •o A sodium (Na+) concentration < 130 or >145 mEq/L (mmol/L)
- •o A potassium (K+) concentration < 3.5 or >5.5 mEq/L (mmol/L)
- •* Have severe anemia, as documented by a hemoglobin < 9 g/dL (< 5.59 mmol/L)
- •* Liver disease defined as history of cirrhosis with evidence of portal hypertension such as varices, or encephalopathy, or total bilirubin > 3 mg/dL (> 51 *mol/L) or significant elevation of liver enzymes (AST, ALT > 3 times the upper limit of normal)
- •* Considered clinically unstable for any condition
- •* Serious comorbid non cardiovascular disease in which the life expectancy of the subject is < 3 months;Other Exclusion Criteria
- •a) Prisoners or participants who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and Bristol-Myers Squibb's approval is required.
- •b) Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- •c) Participation in an investigational clinical drug study within 30 days or 5 elimination half-lives, (whichever is longer) prior to randomization.
- •d) Prior particip
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