Acute Decompensated Heart Failure MedDRA version: 9.1 Level: LLT Classification code 10064653 Term: Acute decompensated heart failure
Conditions
Interventions
Product Name: Chimeric natriuretic peptide - CDNP
Product Code: CD-NP
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: CD-NP
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
Nile Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be between 18 and 85 years of age, inclusive. 2. Systolic blood pressure = 115 mmHg and = 200 mmHg and diastolic blood pressure = 60 mmHg and = 110 mmHg at the time of screening. 3. Hospitalized for ADHF (decompensated chronic HF or acute HF). Patients who develop ADHF while hospitalized for another reason are not eligible. 4. The underlying primary etiology for ADHF should be cardiac rather than pulmonary disease. For this study, ADHF requires all of the following at the time of screening: a. Dyspnea at rest (sitting or supine) or with minimal exertion (such as, talking, eating, etc.); b. Pulmonary congestion on chest radiograph (X-ray) or on physical examination; and c. BNP = 300 pg/mL or NT-pro-BNP = 1200 pg/mL. 5. Compromised renal function defined as CrCL from 30 to 89 mL/min (as estimated by either Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) Study equations). 6. Able to begin study drug infusion within 24 hours from presentation to the hospital, including time spent in the emergency department. 7. Female patients must be post-menopausal or surgically sterile. A woman may be considered to be surgically sterilized if she has had a bilateral tubal ligation (for at least 6 months), bilateral oopherectomy or complete hysterectomy. 8. Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication. The following criteria must continue to be met prior to study drug initiation: 1. Systolic blood pressure = 115 mmHg and = 200 mmHg and DBP = 60 mmHg and = 110 mmHg. 2. Has not received IV bolus dose of furosemide or equivalent loop diuretic including doses administered in the ambulance or emergency department, in excess of the following: - 40 mg within 6 hours prior to study drug initiation - 80 mg within 8 hours prior to study drug initiation - 100 mg within 10 hours prior to study drug initiation 3. Has not received IV bolus dose of furosemide or equivalent loop diuretic within 2 hours prior to study drug initiation. 4. If receiving continuous IV infusion of diuretics or nitrates, the dose has not been up-titrated within 2 hours prior to dosing. 5. No morphine administration within 2 hours prior to dosing and able to withhold morphine administration for the first 6 hours after study drug initiation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acute or suspected acute myocardial infarction (AMI) or troponin levels > 5X3X the upper limit of normal at the institution’s local laboratory. 2. Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to screening. 3. Current or planned treatment with any of the following therapies prior to study drug initiation: a. IV infusion of nesiritide, inotropic agents or vasopressors. b. Received or planned to receive IV bolus dose(s) of furosemide or equivalent loop diuretic including doses administered in the ambulance or emergency department, in excess of the following: - 40 mg within 6 hours prior to study drug initiation - 80 mg within 8 hours prior to study drug initiation - 100 mg within 10 hours prior to study drug initiationin excess of 40 mg as a single dose c. mechanical support (such as, intra-aortic balloon pumps, mechanical ventilation, or any ventricular assist device). d. continuous positive positive airway pressure (CPAP). e. intubation. 4. Cardiogenic shock. 5. Evidence of uncorrected volume depletion 6. Hyponatremia defined as serum Na = 130 mEq/L. 7. Clinically significant aortic or mitral valve stenosis. 8. Temperature > 38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment. 9. ADHF due to significant arrhythmias (ventricular tachycardia, bradyarrhythmias with ventricular rate 160 beats per minute). 10. Severe renal failure defined as creatinine clearance 3 mg/dL, albumin < 2.8 mg/dL, with other signs or symptoms of hepatic dysfunction or increased ammonia levels, if performed with other signs or symptoms of hepatic dysfunction ). 18. Received an investigational drug within 30 days prior to screening. 19. Women who are pregnant or breastfeeding. 20. Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds. 21. Any condition which could interfere with, or for which the treatment might interfere with the conduct of the study, or which would unacceptably increase the risk of the patient's participation in the study. This may include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy, or any unexplained blackouts. 22. Patients diagnosed with Chagas’ cardiomyopathy. 23. Administration of IV contrast agent within the past 48 hours 24. Known predisposition to excessive vasodilatation in response to blood pressure lowering medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of CD-NP infusion ;Secondary Objective: The secondary objectives of this study are to assess efficacy of CD-NP on improvement of clinical symptoms and major adverse cardiac and renal events, to explore dose relationship of CD-NP on biomarkers such as creatinine, Cystatin-C, NGAL, KIM1, and to explore relationship of CD-NP use to urine volume output, hospital readmission and medication intensification. ;Primary end point(s): Key safety endpoints will include: · The occurrence of symptomatic hypotension from start of study drug to within 6 hours after discontinuation of study drug · The occurrence of either of the following from start of study drug to within 6 hours after discontinuation of study drug: o a decrease in systolic blood pressure of at least 20 mm Hg to < 90 mmHg, or o symptomatic hypotension. | — |
Countries
Germany
Outcome results
None listed