Study of Low Dose Nesiritide With or Without Sildenafil in Congestive Heart Failure Patients With Renal Dysfunction

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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 acute decompensated heart failure complicated by the cardiorenal syndrome.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Natriuretic Peptide, Brain; Sildenafil Citrate

Criteria

Inclusion Criteria:

• 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:

1. no change in NYHA symptoms over the past 3 months;

2. on stable doses of ACE inhibitor and beta blocker for one month;

3. 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 Criteria:

• 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