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

Heart Failure Clinical Trial

Official title:

Comparative Effects of Conivaptan and Loop Diuretics on Plasma Neurohormones and Systemic and Renal Hemodynamics in Subjects With Chronic Congestive Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00924014
• Other study ID #: 001
• Secondary ID: IND 104, 334
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2009
• Last updated: June 17, 2009
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: June 2009
• Source: Hennepin County Medical Center, Minneapolis
• Contact: Shari Mackedanz, RN BSN
• Phone: 612-347-5195
• Email: shari.mackedanz[@]hcmed.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Conivaptan
Conivaptan 20 mg IV bolus followed by a 4 hour infusion at 1.2 mg/hr
• Furosemide
Furosemide will be given IV at the subjects usual oral dose up to 80 mg. If the dose is 80 mg or more only 1/2 the dose will be given IV.
• Conivaptan and furosemide
Furosemide bolus first; conivaptan 20 mg IV bolus/infusion at 1.2 mg/hour for a total of 4 hours

Locations

Country	Name	City	State
United States	Hennepin county Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Hennepin County Medical Center, Minneapolis	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal hemodynamics renal blood flow and glomerular filtration rate		measured on days 1, 2, 3	No
Secondary	measure plasma neurohormone levels		predose, 1 hour and 4 hours post dose measured on day 1, 2, 3	No