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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00924014

Enrollment

Registered

2009-06-18

Start date

2009-07-31

Completion date

2010-03-31

Last updated

2009-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure

Brief summary

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

Detailed 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).

Interventions

DRUGConivaptan

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

DRUGFurosemide

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.

DRUGConivaptan and furosemide

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
renal hemodynamics renal blood flow and glomerular filtration rate	measured on days 1, 2, 3

Secondary

Measure	Time frame
measure plasma neurohormone levels	predose, 1 hour and 4 hours post dose measured on day 1, 2, 3

Countries

United States

Contacts

Primary ContactShari Mackedanz, RN BSN

shari.mackedanz@hcmed.org612-347-5195

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026