Study of Low Dose Nesiritide With or Without Sildenafil in Congestive Heart Failure Patients With Renal Dysfunction

NCT00818701 | Terminated Phase 1 DMC

• 2 other identifiers: 08-004797BNP + PDEVI
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Congestive Heart Failure; Renal Dysfunction

Keywords

Congestive Heart Failure; Congestive Heart Failure with a NYHF Class 2-3; Ejection Fraction of 35 or less

Outcome Measures

Primary Outcomes (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.)

  prospective

Secondary Outcomes (1)

• We also want to characterize both plasma and urinary humoral profile in these patients.

  prospective

Study Arms (2)

1: low dose BNP alone

PLACEBO COMPARATOR

low dose BNP with placebo

Drug: low dose Nesiritide

2: low dose BNP + PDEVI

ACTIVE COMPARATOR

low dose BNpo + PDEVI

Drug: nesiritide, Sildenafil

Interventions

low dose Nesiritide DRUG

Nesiritide infusion 0.005ug/kg/min

Also known as: Natracor

1: low dose BNP alone

nesiritide, Sildenafil DRUG

Nesiritide 0.005ug/kg/min Sildenafil 50 mg

Also known as: Natrecor, Viagra

2: low dose BNP + PDEVI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• no change in NYHA symptoms over the past 3 months;
• on stable doses of ACE inhibitor and beta blocker for one month;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency

Interventions

Natriuretic Peptide, Brain; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Horng H Chen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 8, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 24, 2010

Record last verified: 2010-09

Locations

US (2)