Study of Low Dose Nesiritide With or Without Sildenafil in Congestive Heart Failure Patients With Renal Dysfunction
Stopped early · Phase 1
Conditions studied: Congestive Heart Failure, Renal Dysfunction
In brief
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 acute decompensated heart failure complicated by the cardiorenal syndrome.
Key facts
- Study ID
- NCT00818701
- Run by
- Mayo Clinic
- People needed
- 1
- Starts
- 2009-02-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2010-09-24
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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