Overview

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