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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00818701 |
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.
Condition | Intervention | Phase |
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Congestive Heart Failure Renal Dysfunction |
Drug: low dose Nesiritide Drug: nesiritide, Sildenafil |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Randomized, Double Blinded Placebo Controlled Cross-Over Study of Low Dose B-Type Natriuretic Peptide (Nesiritide) With or Without Concomitant Phosphodiesterase V (PDE V) Inhibition(Sildenafil) in Congestive Heart Failure Patients With Renal Dysfunction |
Estimated Enrollment: | 20 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: low dose BNP alone: Placebo Comparator
low dose BNP with placebo
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Drug: low dose Nesiritide
Nesiritide infusion 0.005ug/kg/min
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2: low dose BNP + PDEVI: Active Comparator
low dose BNpo + PDEVI
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Drug: nesiritide, Sildenafil
Nesiritide 0.005ug/kg/min Sildenafil 50 mg
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Renal dysfunction is a common comorbidity, as well as a common and progressive complication, of heart failure (HF). Increasingly, the clinical syndrome of HF is one of "cardiorenal" failure owing to the frequent presentation of combined cardiac and renal dysfunction. Recent studies have established the prognostic importance of renal dysfunction in patients with chronic HF. An analysis of the patients in the second prospective randomized study of Ibopamine on mortality and efficacy (PRIME) by Hillege et al1 demonstrated that estimated glomerular filtration rate (GFR) is the most powerful predictor of mortality, exceeding functional status and ejection fraction (EF).
In an ongoing prospective study, we are assessing the neurohumoral and renal hemodynamic profile of hospitalized patients with ADHF who do or do not develop the CRS. Our preliminary findings suggest that indeed the combination of pronounced activation of renin-angiotensin-aldosterone system (RAAS), decreased renal perfusion pressure and importantly, a relative deficiency of the natriuretic peptides (despite marked volume overload) predisposes to the development of CRS.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Stable (NYHA) class II and III symptoms as defined by:
Exclusion Criteria:
Responsible Party: | Mayo Clinc ( Dr Horng H. Chen ) |
Study ID Numbers: | 08-004797, BNP + PDEVI |
Study First Received: | January 6, 2009 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00818701 |
Health Authority: | United States: Institutional Review Board |
Congestive Heart Failure Congestive Heart Failure with a NYHF Class 2-3 Ejection Fraction of 35 or less |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Sildenafil |
Vasodilator Agents Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Natriuretic Agents Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |