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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-03-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Conivaptan

Conivaptan will be given via IV bolus

Group Type ACTIVE_COMPARATOR

Conivaptan

Intervention Type DRUG

Conivaptan 20 mg IV bolus followed by a 4 hour infusion at 1.2 mg/hr

Furosemide

Furosemide will be given via IV bolus

Group Type ACTIVE_COMPARATOR

Furosemide

Intervention Type DRUG

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

on day 3 subjects will receive both study drugs

Group Type ACTIVE_COMPARATOR

Conivaptan and furosemide

Intervention Type DRUG

Furosemide bolus first; conivaptan 20 mg IV bolus/infusion at 1.2 mg/hour for a total of 4 hours

Interventions

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Conivaptan

Conivaptan 20 mg IV bolus followed by a 4 hour infusion at 1.2 mg/hr

Intervention Type 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.

Intervention Type DRUG

Conivaptan and furosemide

Furosemide bolus first; conivaptan 20 mg IV bolus/infusion at 1.2 mg/hour for a total of 4 hours

Intervention Type DRUG

Other Intervention Names

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vaprisol Lasix vaprisol lasix

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No