Renal Effects of Intrarenal Nesiritide

NCT00270829 | Terminated Phase 4

• 1 other identifier: H-26854
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The impact of nesiritide in CHF is unclear, but it is possible that systemic vasodilation leads to adverse consequences even if the direct renal effects are positive. Therefore, this study will look at the effects of direct intrarenal administration of nesiritide on GFR and RPF.

Conditions

Heart Failure, Congestive

Keywords

renal function

Outcome Measures

Primary Outcomes (1)

• GFR

  hours

Secondary Outcomes (3)

• Urine output

  hours

• RPF

  hours

• sodium excretion

  hours

Study Arms (2)

1

EXPERIMENTAL

Nesiritide given intrarenally

Drug: nesiritide

2

NO INTERVENTION

No intrarenal drug administration

Interventions

nesiritide DRUG

Drug given intrarenally or placebo

1

Eligibility Criteria

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

You may qualify if:

• Hospitalized for worsening CHF and volume overload
• Creatinine increased by greater than or equal to 0.2 and greater than or equal to 10% above baseline at study initiation
• Age greater than or equal to 18 years
• NHYA class II-IV at the time of initiation in the study
• EF less than or equal to 40%
• Signed Informed Consent

You may not qualify if:

• Current or anticipated need for dialysis during the study period
• Systolic blood pressure less than or equal to 90 mmHg
• Calculated CrCL based on Cockcroft-Gault less than or equal to 15 cc/min
• Hypersensitivity to nesiritide
• Cardiogenic shock
• Clinically significant aortic or mitral stenosis
• Contraindication to vasodilator treatment
• Inability to withstand 11-15 hours without diuretics
• Suspected renal deterioration due to causes unrelated to CHF such as radiocontrast administration, NSAID use
• Receipt of dose of NSAID within 12 hours of study drug initiation
• Use of radiocontrast media within 7 days of study drug initiation (other than the small amount of IV contrast that will be needed to place intrarenal catheter to the level of the renal artery)
• Use of nephrotoxic drugs such as aminoglycosides or cisplatinum within 7 days of study initiation
• Use of sildenafil or other PDE5 inhibitors within 24 hours of study drug initiation
• Diseases of weak collagen (i.e. Marfans)
• Aortic or renal aneurysm

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular 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

Study Officials

• Stephen S Gottlieb

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor o Medicine

Study Record Dates

• First Submitted: December 23, 2005
• First Posted: December 28, 2005
• Study Start: December 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

US (1)