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Clinical Trials/EUCTR2006-006843-29-GR
EUCTR2006-006843-29-GRActive, not recruitingNot Applicable

A multicentre, randomized, double-blind, placebo controlled study of the effects of KW-3902 Injectable Emulsion on heart failure signs and symptoms, diuresis, renal function, and clinical outcomes in subjects hospitalized with worsening renal function and heart failure requiring intravenous therapy. - REACH UP

ovaCardia Inc0 sites480 target enrollmentStarted: September 17, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
480
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Able to provide written informed consent, or a legally authorised representative is able to provide written informed consent.
  • •2. Male or female 18 years of age or greater.
  • •3. Dyspnea at rest or with minimal exertion at randomisation.
  • •4. Fluid overload as manifested by at least one of the following present at randomization:
  • •JVP >10 cm OR Pulmonary rales =1/3 up the lung fields, not clearing with cough,
  • •OR =2+ peripheral or pre-sacral edema
  • •5. Estimated creatinine clearance (CrCl) between 20–60 mL/min using the Cockcroft-Gault equation (corrected for height in edematous subjects =100 kg) based on a serum creatinine (SCr) value drawn within approximately 6 hours of randomization
  • •6. Worsening renal function as manifested by one of the following present at randomization:
  • •An increase in SCr of at least 25% and at least 0.3 mg/dL from the time of initial presentation for this hospitalization in patients hospitalized with heart failure requiring IV diuretic therapy, OR
  • •A documented increase in SCr over the preceding 30 days prior to randomization of at least 40% and at least 0.3 mg/dL in patients being admitted for heart failure requiring IV therapy (these patients must be randomized within 24 hours of
  • •7. Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug
  • •8. BNP >500 pg/mL or NT-pro-BNP >2000 pg/mL
  • •9. Systolic blood pressure =90 mmHg at randomization. Subjects with systolic blood pressure of 85-89 mmHg at randomization may be included if their usual systolic blood pressure measurements are consistently within 85-89 mmHg while clinically stable.
  • •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

  • •1. Previous exposure to KW-3902
  • •2. Pregnant or breast feeding women. Women of child bearing potential must have a negative serum pregnancy test prior to enrollment.
  • •3. Any administration of IV radiographic contrast within 14 days of randomization or any procedures with IV radiographic contrast planned during this hospitalization
  • •4. Administration of IV vasodilators within 6 hours of randomization (with the exclusion of nitrates, which are allowed)
  • •5. Serum potassium <3.5 meq/L (3.0–3.4 meq/L will be allowed if adequate parenteral supplemental potassium is being administered)
  • •6. Ongoing or planned therapy for heart failure with mechanical circulatory support (intra-aortic balloon pump, endotracheal intubation, ventricular assist device) or ventilatory support (including BiPAP or CPAP)
  • •7. Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis during this hospitalization
  • •8. Rapidly progressive acute renal failure as manifested by an increase in SCr =0.7 mg/dL in a 24-hour period
  • •9. Evidence of acute tubular necrosis (urinary sediment, urinary sodium excretion, biopsy, etc.) or post-obstructive nephropathy or other exogenous causes of acute kidney injury, unrelated to heart failure or its treatment (contrast media,cyclosporine, other nephrotoxins)
  • •10. Severe pulmonary disease (as evidenced by pre-admission or current oral steroid dependency, current treatment with IV steroids, or previous history of CO2 retention or intubation for acute exacerbation)
  • •11. Significant stenotic mitral or aortic valvular disease
  • •12. Heart transplant recipient or admitted for cardiac transplantation or LVAD surgery
  • •13. Any major surgery within 2 weeks prior to screening (cardiac or non-cardiac)
  • •14. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening
  • •15. Hgb <8 g/dL, Hct <25%, or active bleeding requiring transfusion
  • •16. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. This criterion does not include restrictive patterns seen on Doppler.
  • •17. Known hepatic impairment (total bilirubin >3 mg/dL, albumin <2.8 mg/dL, or increased ammonia levels if performed)
  • •18. Non-cardiac pulmonary edema
  • •19. Temperature >38°C (oral or equivalent)
  • •20. Sepsis or active infection requiring IV anti-microbial treatment
  • •21. Administration of an investigational drug or device or participation in another trial within 30 days before randomization
  • •22. Current or anticipated therapy with atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
  • •23. Administration of any vasopressor or inotropic drug within 72 hours of randomization (with the exception of ongoing dopamine or dobutamine at doses =5 mcg/kg/min or milrinone at a dose of =0.25 mcg/kg/min, which are allowed IF at a stable dose for the preceding 24 hours AND provided there has been no decrease in SCr during the prior 24 hours)
  • •24. Inability to follow instructions or comply with study procedures
  • •25. Allergy to soybean oil or eggs
  • •26. History of seizure (except febrile seizure)
  • •27. Stroke within 2 years
  • •28. History of brain tumor of any etiology
  • •29. Brain surgery within 2 years
  • •30. Encephalitis/meningitis within 2 years
  • •31. History of penetrating head trauma
  • •32. Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years
  • •33. History of or at risk for alcohol withdrawal seizures
  • •34. Advanced Alzheimer’s disease
  • •35. Advanced multiple sc

Investigators

Sponsor
ovaCardia Inc

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