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

Study Overview
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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.

Detailed Description
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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).

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Conivaptan
* Drug: Furosemide
* Drug: Conivaptan and furosemide


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conivaptan<br>Conivaptan will be given via IV bolus | Drug: Conivaptan<br>* Conivaptan 20 mg IV bolus followed by a 4 hour infusion at 1.2 mg/hr<br>* Other names: vaprisol;|
| Active Comparator: Furosemide<br>Furosemide will be given via IV bolus | Drug: Furosemide<br>* 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.<br>* Other names: Lasix;|
| Active Comparator: conivaptan and furosemide<br>on day 3 subjects will receive both study drugs | Drug: Conivaptan and furosemide<br>* Furosemide bolus first; conivaptan 20 mg IV bolus/infusion at 1.2 mg/hour for a total of 4 hours<br>* Other names: lasix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal hemodynamics renal blood flow and glomerular filtration rate |  | measured on days 1, 2, 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure plasma neurohormone levels |  | predose, 1 hour and 4 hours post dose measured on day 1, 2, 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure