Comparing the Effects of Conivaptan and Diuretics on Plasma Neurohormones and Renal Blood Flow in Patients With Chronic Congestive Heart Failure

Not Applicable

• Conditions: Heart Failure
• Interventions: Drug: Conivaptan and furosemide; Drug: Conivaptan; Drug: Furosemide

• Registration Number: NCT00924014
• Lead Sponsor: Hennepin County Medical Center, Minneapolis

Brief Summary

The purpose of the study is to compare the effects of conivaptan and diuretics on renal blood flow and neurohormones.

Detailed Description

1. To define the hemodynamic, neurohormonal and renal responses to intravenous conivaptan in patients with chronic stable heart failure (HF), and compare these responses to those after intravenous furosemide.

2. To define the hemodynamic, neurohormonal and renal responses to the combination of the two drugs (conivaptan and furosemide).

Study Timeline

• Status Verified: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Last Update Submitted: 2009-06-17
• Study First Posted: 2009-06-18
• Last Update Posted: 2009-06-18
• Study Start: 2009-07
• Primary Completion: 2009-12
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Have a diagnosis of chronic congestive heart failure of any etiology
• Be between 18-80 years of age
• Able to provide consent
• Have a documented left ventricular ejection fraction within the last year of < 40%
• On a stable dose (no changes within 2 weeks) of 40 mg or greater daily dose of furosemide or its equivalent
• On standard HF therapy medications (ACEI or ARB and beta-blocker unless contraindicated)
• Have an estimated glomerular filtration rate (GFR) of 30 ml/minute or greater (based on the Cockcroft Gault calculation)
• Have a hemoglobin of > 10 grams/dl
• Have a negative urine pregnancy for women of childbearing years only

Exclusion Criteria

• Acute coronary syndrome within 1 month
• Systolic blood pressure less than or equal to 90 mmHg at time of enrollment
• Poor peripheral venous access
• Severe concomitant disease which deemed by the investigator would render them unsuitable for this trial
• Allergy or contraindication to the use of iothalamate, PAH - Specifically any allergies to iodine or iodine containing products, history of asthma and hay fever which deemed by the investigator would render them unsuitable for this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conivaptan and furosemide	Conivaptan and furosemide	on day 3 subjects will receive both study drugs
Conivaptan	Conivaptan	Conivaptan will be given via IV bolus
Furosemide	Furosemide	Furosemide will be given via IV bolus

Primary Outcome Measures

Name	Time	Method
renal hemodynamics renal blood flow and glomerular filtration rate	measured on days 1, 2, 3

Secondary Outcome Measures

Name	Time	Method
measure plasma neurohormone levels	predose, 1 hour and 4 hours post dose measured on day 1, 2, 3

Trial Locations

Locations (1)

Hennepin county Medical Center; 🇺🇸 Minneapolis, Minnesota, United States