Status:
COMPLETED
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
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Heart Failure
Renal Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 i...
Detailed Description
The broad objective of this protocol is to advance our understanding of the pathophysiological mechanisms of human Cardiorenal Syndrome (CRS) with a specific emphasis upon the biological interaction b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00972569
Start Date
October 1 2009
End Date
December 1 2019
Last Update
January 18 2020
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