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

Hennepin Healthcare

Status: Unknown

Conditions: Heart Failure

Treatments: Drug: Conivaptan and furosemide; Drug: Furosemide; Drug: Conivaptan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00924014

001

IND 104, 334

Details and patient eligibility

About

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

Full 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).

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 3 patient groups

Conivaptan

Active Comparator group

Description:

Conivaptan will be given via IV bolus

Treatment:

Drug: Conivaptan

Furosemide

Active Comparator group

Description:

Furosemide will be given via IV bolus

Treatment:

Drug: Furosemide

conivaptan and furosemide

Active Comparator group

Description:

on day 3 subjects will receive both study drugs

Treatment:

Drug: Conivaptan and furosemide