Hemodynamic Effects of Rolofylline in the Treatment of Patients with Heart FailureA multicenter, randomized, double-blind, placebo-controlled study of the hemodynamic effects of rolofylline injectable emulsion in the treatment of patients with heart failure - 503

• Conditions: Patients with heart failure and renal impairment, who require loopdiuretic therapy and at least 12 hours of hemodynamic monitoring inthe period after screening, and who satisfy the eligibility criteria.; MedDRA version: 9.1Level: HLGTClassification code 10007539Term: Cardiac disorder signs and symptoms

• Registration Number: EUCTR2008-002209-38-IT
• Lead Sponsor: ovaCardia Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Able to provide written informed consent
2. Male or female 18 years of age or greater
3. Current use of oral furosemide ≥80 mg/day or IV furosemide ≥40
mg/day (or equivalent dose of oral/IV loop diuretic)
4. Stable heart failure therapy (excluding diuretics) for ≥24 hours
prior to screening (treatment with ACE inhibitors, ARBS, digoxin, aldosterone blockers, nitrates, hydralazine, and other diuretics are allowed as long as doses are stable for at least 24 hours prior to screening)
5. Impaired renal function defined as a creatinine clearance between
20-80 mL/min using the Cockcroft-Gault equation (corrected for height in edematous or obese patients ≥100 kg) based on serum creatinine measurements done within 24 hours of screening
6. BNP >500 pg/mL OR NT-pro-BNP >2000 pg/mL within 24 hours of screening
7. Systolic blood pressure ≥95 mmHg (patients with a systolic blood pressure of 90 ? 94 mmHg at randomization may be included if their usual systolic blood pressure measurements are consistently within this range while clinically stable)
8. Patients require at least 12 hours of hemodynamic monitoring in the period after screening.
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

9. Pregnant or breast feeding women. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
10. Acute contrast induced nephropathy
11. Temperature >38C or sepsis or active infection requiring IV antimicrobial treatment
12. Administration of oral or IV loop diuretic within 3 hours prior to
the initial screening
13. Serum potassium <3.5 mEq/L
14. Ongoing, recent (within 48 hours), or planned treatment with
ultrafiltration, hemofiltration, or dialysis, or mechanical support
(intra-aortic balloon pump, endotracheal intubation, ventricular
assist device) during this hospitalization
15. Rapidly progressive acute renal failure as manifested by an
increase in SCr ≥0.7 mg/dL in a 24-hour period
16. Evidence of acute tubular necrosis or post-obstructive nephropathy or other exogenous causes of acute kidney injury, unrelated to heart failure or its treatment
17. Severe pulmonary disease
18. Severe aortic or mitral stenosis or regurgitation
19. Heart transplant recipient or admitted for imminent cardiac
transplantation or LVAD surgery (i.e., expected within 72 hours)
20. Any major surgery within 2 weeks prior to screening
21. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening
22. Significant arrhythmias
23. Acute myocarditis or hypertrophic obstructive, restrictive, or
constrictive cardiomyopathy. This criterion does not include restrictive patterns seen on Doppler.
24. Known hepatic impairment with a total bilirubin >3 mg/dL, or an
albumin <2.8 mg/dL, or increased ammonia levels (if available)
25. Body Mass Index (BMI) >35 kg/m2
26. Hgb <8 g/dL or Hct <25%, or the need for a blood transfusion
27. Non-cardiac pulmonary edema, including suspected sepsis
28. Administration of an investigational drug or device, or
participation in another trial, within 30 days before randomization
29. Current or anticipated therapy with atazanavir, clarithromycin,
indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
30. Systolic blood pressure ≥160 mmHg at randomization
31. Inability to follow instructions or comply with follow-up procedures
32. Allergy to soybean oil, eggs, or benzodiazepines
33. History of seizure (except febrile seizure)
34. Stroke within 2 years
35. History of or current brain tumor of any etiology
36. Brain surgery within 2 years
37. Encephalitis/meningitis within 2 years
38. History of penetrating head trauma
39. Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years
40. History of drug or alcohol abuse or at risk for alcohol withdrawal seizures
41. Advanced Alzheimer?s disease
42. Advanced multiple sclerosis

Baseline Period Criteria
Exclusion Criteria (at least 1 hour prior to dosing):
43. Balloon thermodilution catheter in place <3 hours
44. Wedge pressure ≤18 mmHg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified