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

This study is not yet open for participant recruitment.

Verified by Hennepin County Medical Center, Minneapolis, June 2009

First Received: June 17, 2009 No Changes Posted

Sponsor:	Hennepin County Medical Center, Minneapolis
Collaborator:	Astellas Pharma Inc
Information provided by:	Hennepin County Medical Center, Minneapolis
ClinicalTrials.gov Identifier:	NCT00924014

Purpose

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

Condition	Intervention
Heart Failure	Drug: Conivaptan Drug: Furosemide Drug: Conivaptan and furosemide

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment
Official Title:	Comparative Effects of Conivaptan and Loop Diuretics on Plasma Neurohormones and Systemic and Renal Hemodynamics in Subjects With Chronic Congestive Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Furosemide YM 087 Conivaptan

U.S. FDA Resources

Further study details as provided by Hennepin County Medical Center, Minneapolis:

Primary Outcome Measures:

renal hemodynamics renal blood flow and glomerular filtration rate [ Time Frame: measured on days 1, 2, 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

measure plasma neurohormone levels [ Time Frame: predose, 1 hour and 4 hours post dose measured on day 1, 2, 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	8
Study Start Date:	July 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Conivaptan: Active Comparator Conivaptan will be given via IV bolus	Drug: Conivaptan Conivaptan 20 mg IV bolus followed by a 4 hour infusion at 1.2 mg/hr
Furosemide: Active Comparator Furosemide will be given via IV bolus	Drug: 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: Active Comparator on day 3 subjects will receive both study drugs	Drug: Conivaptan and furosemide Furosemide bolus first; conivaptan 20 mg IV bolus/infusion at 1.2 mg/hour for a total of 4 hours

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924014

Contacts

Contact: Shari Mackedanz, RN BSN

612-347-5195

shari.mackedanz@hcmed.org

Locations

United States, Minnesota
Hennepin county Medical Center
Minneapolis, Minnesota, United States, 55404

Sponsors and Collaborators

Hennepin County Medical Center, Minneapolis

Astellas Pharma Inc

Investigators

Study Director:

Steven R Goldsmith, MD

Hennepin County Medical Center, Minneapolis

More Information

No publications provided

Responsible Party:	Hennepin County Medical Center ( Steven R. Goldsmith )
Study ID Numbers:	001, IND 104, 334
Study First Received:	June 17, 2009
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00924014 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hennepin County Medical Center, Minneapolis:

heart failure

Additional relevant MeSH terms:

Heart Failure
Neurotransmitter Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Cardiovascular Agents

Furosemide
Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Sodium Potassium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010