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Study of Low Dose Nesiritide With or Without Sildenafil in Congestive Heart Failure Patients With Renal Dysfunction (BNP+PDEVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00818701
Recruitment Status : Terminated (started a NIH study that is competing for same subjects)
First Posted : January 8, 2009
Last Update Posted : September 24, 2010
Information provided by:
Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Renal Dysfunction Drug: low dose Nesiritide Drug: nesiritide, Sildenafil Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : February 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Placebo Comparator: 1: low dose BNP alone
low dose BNP with placebo
Drug: low dose Nesiritide
Nesiritide infusion 0.005ug/kg/min
Other Name: Natracor

Active Comparator: 2: low dose BNP + PDEVI
low dose BNpo + PDEVI
Drug: nesiritide, Sildenafil
Nesiritide 0.005ug/kg/min Sildenafil 50 mg
Other Names:
  • Natrecor
  • Viagra

Primary Outcome Measures :
  1. To determine the efficacy of low dose BNP alone vs low dose BNP + PDE V inhibition in improving renal function in patients with CHF and renal dysfunction. (Calculated creatinine clearance = or < than 60 ml/min and > 30 ml/min, within 12 months.) [ Time Frame: prospective ]

Secondary Outcome Measures :
  1. We also want to characterize both plasma and urinary humoral profile in these patients. [ Time Frame: prospective ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00818701

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Horng H Chen, MD Mayo Clinic

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Responsible Party: Dr Horng H. Chen, Mayo Clinc Identifier: NCT00818701    
Other Study ID Numbers: 08-004797
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: September 24, 2010
Last Verified: September 2010
Keywords provided by Mayo Clinic:
Congestive Heart Failure
Congestive Heart Failure with a NYHF Class 2-3
Ejection Fraction of 35 or less
Additional relevant MeSH terms:
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Renal Insufficiency
Heart Failure
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Natriuretic Peptide, Brain
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Natriuretic Agents
Physiological Effects of Drugs