Status:
TERMINATED
Study of Low Dose Nesiritide With or Without Sildenafil in Congestive Heart Failure Patients With Renal Dysfunction
Lead Sponsor:
Mayo Clinic
Conditions:
Congestive Heart Failure
Renal Dysfunction
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to show that low dose recombinant BNP coupled with phosphodiesterase V inhibition will improve renal dysfunction and promote relief of volume overload in patinets with acut...
Detailed Description
Renal dysfunction is a common comorbidity, as well as a common and progressive complication, of heart failure (HF). Increasingly, the clinical syndrome of HF is one of "cardiorenal" failure owing to t...
Eligibility Criteria
Inclusion
- Left ventricular ejection fraction 35% assessed by echocardiography, nuclear scan or left ventriculogram within the past 2 years
- Stable (NYHA) class II and III symptoms as defined by:
- no change in NYHA symptoms over the past 3 months;
- on stable doses of ACE inhibitor and beta blocker for one month;
- no episode of decompensated CHF over the past 3 months.
- Calculated creatinine clearance of equal or less than 60 ml/min and greater than 30 ml/min, using the Cockcroft-Gault formula assessed within the past 12 months
Exclusion
- Nitrates or alpha blockers
- Prior diagnosis of intrinsic renal diseases including renal artery stenosis of \> 50%
- Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period
- Hospitalization for decompensated CHF during the past 3 months
- Myocardial infarction within 3 months of screening
- Unstable angina within 3 months of screening or any evidence of myocardial ischemia
- Significant valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis
- Severe congenital heart diseases
- Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
- Second or third degree heart block without a permanent cardiac pacemaker
- Stroke within 3 months of screening or other evidence of significantly compromised CNS perfusion
- Serum sodium of \< 125 mEq/dL or \> 150 mEq/dL
- Serum potassium of \< 3.5 mEq/dL or \> 5.7 mEq/dL
- Hemoglobin \< 10 gm/dl
- Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data
- Received an investigational drug within 1 month prior to dosing
- Patients with an allergy to iodine.
- Female subject who is pregnant or breastfeeding
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00818701
Start Date
February 1 2009
End Date
August 1 2010
Last Update
September 24 2010
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55902
2
Mayo Clinic
Rochester, Minnesota, United States, 55905