Low Dose Intravenous (IV) Infusion of BNP in the Presence and Absence of Acute Type V Phosphodiesterase (PDE V) in Improving Renal Function in Hospitalized Chronic Heart Failure (CHF) Patients With Renal Dysfunction

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if low doses of BNP can improve renal function in people with chronic heart failure with renal dysfunction, also to determine whether Sildenafil assists with improvement. This study will enroll only hospitalized patients with heart failure.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Institutes of Health (NIH)
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• Patients admitted to St Mary's Hospital, Mayo Clinic Rochester MN with NYHA class III-IV decompensated CHF with renal dysfunction as Calculated creatinine clearance of equal or less than 60 ml/min but greater than 20 ml/min using the Cockcroft-Gault formula.

Exclusion Criteria:

• Cause of acute renal dysfunction can be reasonably ascribed to factors other than heart failure or its treatment

• Known intrinsic renal diseases or renal artery stenosis of =>50%

• Patients taking Nitrates within the previous 24 hours

• Patients needing emergency coronary revascularization or those who may have rapidly changing cardiac function (i.e. patients with acute myocardial infarction or shock)

• Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period

• Systolic blood pressure < 90 mmHg or cardiogenic shock.

• Requirement of pressors for maintenance of blood pressure.

• Intra-aortic blood pump use.

• History of significant uncorrected renal artery stenosis as defined by >50% stenosis.

• Severe aortic or mitral stenosis or significant LV outflow tract obstruction. Hgb < 10 mg/dL

• Pregnant or nursing women.

• Contraindication to nesiritide.

• Inability to have NSAID dose held for up to 30 hours, if being treated with these medications.

• Administration of radiocontrast medium within 7 days of enrollment or anticipated use of such agents during the study