Evaluation of Combined Action Between Natrecor and Furosemide on Kidney and Neurohormone Responses in Chronic Heart Failure: A Phase-IV study704.351 / DSS

NCT00652652 | Completed Phase 4

• 1 other identifier: CR003319
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, open-label, three-way crossover design study with 3 treatment groups:TREATMENT A: Furosemide;TREATMENT B: Nesiritide administered IV bolus, followed by an infusion for 6 hours;TREATMENT C: Treatment B for at least 15 minutes, then administration of treatment AAll sequences involving both furosemide and nesiritide had the nesiritide infusion started first, at least 15 minutes before furosemide was administered. Each treatment will be administered according to 1 of 6 sequences to which patients are randomized. Patients will remain in the Clinical Research Unit for 7 days, with treatments administered on Days 2, 4, and 6, with equilibrium (rest) days on Days 1, 3, and 5. All patients will be followed for safety throughout the treatment phase, and by telephone between 7 and 14 days after they are discharged from the Clinical Research Unit.

Conditions

Congestive Heart Failure; Chronic Heart Failure

Keywords

Congestive Heart Failure (CHF); Heart Failure; Chronic Heart Failure; Dyspnea; nesiritide; Natrecor

Outcome Measures

Primary Outcomes (1)

• Patient's urinary excretion rate of sodium

Secondary Outcomes (1)

• Patient's urinary flow rate, urinary excretion of potassium, calcium and magnesium, and urinary excretion of cGMP and furosemide

Interventions

nesiritide, furosemide DRUG

Eligibility Criteria

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

You may qualify if:

• Chronic symptomatic NYHA Class II or III CHF for at least 90 days before the study
• Left ventricular systolic dysfunction as evidenced by left ventricular ejection fraction \< 40%, measured using contrast or radionuclide ventriculography or by echocardiography, within 180 days of the study start
• Serum potassium \> 3.5 mEq/L.
• Chronic oral daily requirement of 80-240 mg of furosemide for at least 7 days before the study start
• Receiving a stable medical regimen for CHF for at least 60 days before the study start, including angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARBs), and/or beta-blockers.

You may not qualify if:

• Clinical instability such that withholding diuretic therapy would be unsafe
• Significant renal impairment (e.g., creatinine clearance \< 45 mL/min by the Cockcroft-Gault formula), or changing renal function during the 7 days before study start, or intrinsic renal disease
• Systolic blood pressure (SBP) consistently \< 90 mm Hg
• Myocardial infarction within 90 days of study start, unstable angina within 14 days of study start, or any clinical evidence of active myocardial ischemia
• Percutaneous coronary intervention or cardiac surgery within 90 days of study start
• Restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, other conditions in which cardiac output was dependent on venous return, or for subjects expected to have low filling pressures
• Prior cardiac or renal allografts

Sponsors & Collaborators

• Scios, Inc.: lead

Related Links

• Evaluation of combined action Between Natrecor and Furosemide on Kidney and Neurohormone Responses in Chronic Heart failure: A Phase-IV study704.351 / DSS

MeSH Terms

Conditions

Heart Failure; Dyspnea

Interventions

Natriuretic Peptide, Brain; Furosemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: March 1, 2003
• Study Completion: January 1, 2004
• Last Updated: May 19, 2011

Record last verified: 2010-03