A Dose-Defining Study of CXL-1020 in Patients With Systolic Heart Failure

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

Study CXL-1020-02 employs is designed to further define suitable clinical dosages for CXL-1020 which will be utilized in a later Phase IIb study. The study is conducted in 3 different stages called 'strata" and evaluates the potential utility of this drug for the treatment of patents who are hospitalized with heart failure.

Key facts

Study ID

NCT01096043

Run by

Bristol-Myers Squibb

People needed

69

Starts

2010-04-01

Expected to finish

2012-02-01

Last updated by the study team

2016-11-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible for randomization, a patient MUST:
• Be a male or post menopausal or surgically sterile female requiring inpatient evaluation or treatment and be between 18 and 85 years of age
• Not require immediate emergent treatment with conventional parenteral inotropes or vasodilators
• Be receiving standard background heart failure therapies as indicated, but not receive an oral dose of a hemodynamically active treatment or diuretic within 3 hours of baseline hemodynamic assessments
• Have chronic Systolic HF due to primary/idiopathic dilated cardiomyopathy, coronary artery disease or hypertension
• For inclusion in the Non-Invasive Strata B, have a baseline (within 48 hours prior to dosing) left ventricular ejection fraction ≤ 35% estimated from a baseline 2D-Echocardiogram
• For inclusion in the Invasive Strata A and C, have baseline hemodynamic values (mean of 3 consecutive CI measurements taken within 1 hours preceding dosing within 10% of one another with a mean CI of less than or equal to (≤) 2.5L/min AND a mean PCWP of greater than 20mmHg
• Have an elevated baseline BNP of at least 400pg/ml in all protocol strata
• Be capable of understanding the nature of the trial and be willing to participate as documented by written informed consent
• Be willing and able to comply with the inpatient and outpatient study protocol requirements for the duration of the study (treatment plus 30 follow up at days)
• If a post-menopausal or surgically sterile female, confirmation of sterility status (post-menopausal or surgically sterile for at least 6 months; post-menopausal subjects will require a urine pregnancy test for confirmation)
• If a fertile male, must be using 2 approved contraceptive methods (a condom and a spermicidal agent, even if partner(s) is using birth control) for 10 days following participation in the study and further agree to not donate sperm for 10 days after participation in the study
• Must have a negative urine test for drugs of abuse and a negative ethanol breath test or blood test at baseline before dosing
• Have required local laboratory safety data within protocol required or local laboratory non-exclusionary ranges before dosing
• May be receiving ICD, Bi V pacing or rate control pacing at the time of randomization so long as no alteration of settings are anticipated within the day of study drug administration
• Exclusion Criteria:
• In order to be eligible for randomization, a patient MUST NOT:
• Have participated in any investigational drug study, SERCa gene therapy or cellular myocardial transplant study within 30 days preceding randomization or have previously received therapy with CXL-1020
• Have received a parenteral or oral dose of diuretics or other hemodynamically active therapy within 3 hours of the baseline hemodynamic assessment
• Have received intravenous inotropes, inodilators or vasodilators (amrinone, digoxin, dopamine, dobutamine, enoximone, levosimendan, milrinone, nesiritide, nitroglycerine or nitroprusside) for more than 4 hours and within 12 hours prior to randomization to treatment with study drug
• Have a heart rate <50 or ≥ 90 BPM at baseline prior to randomization
• Have a blood pressure >150 Systolic and/or >95 diastolic mmHg at baseline prior to randomization
• Have a systolic blood pressure of less than 100 mmHg at baseline prior to randomization
• Be in atrial fibrillation/flutter at the time of randomization or have a history of recent intermittent A-fib/flutter within the previous week
• Have non-sustained VT (HR > 120 bpm) of 10 beats or more during bedside monitoring prior to randomization or excessive VPB's or complex multifocal ventricular ectopy exceeding 10 beats per minute on a 2 minute rhythm strip taken within 10 minutes prior to randomization

Where it is running

• University of Florida — Gainesville, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• Florida Hospital Transplant Center — Orlando, Florida, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• DMC Cardiovascular Institute — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Medicine & Dentistry of New Jersey - New Jersey Medical School — South Orange, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Davis Heart & Lung Research Institute — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Stern Cardiovascular Center PA — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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