Clinical trial NCT00924014: Comparing the Effects of Conivaptan and Diuretics on Plasma Neurohormones and Renal Blood Flow in Patients With Chronic Congestive Heart Failure
Official title: Comparative Effects of Conivaptan and Loop Diuretics on Plasma Neurohormones and Systemic and Renal Hemodynamics in Subjects With Chronic Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
Lead sponsor: Hennepin County Medical Center, Minneapolis
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2009-06-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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).

Eligibility 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

Primary outcomes:
measure: renal hemodynamics renal blood flow and glomerular filtration rate
timeFrame: measured on days 1, 2, 3
Secondary outcomes:
measure: measure plasma neurohormone levels
timeFrame: predose, 1 hour and 4 hours post dose measured on day 1, 2, 3
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin county Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Steven R Goldsmith, MD
role: STUDY_DIRECTOR
References:
citation: Goldsmith SR, Gilbertson DT, Mackedanz SA, Swan SK. Renal effects of conivaptan, furosemide, and the combination in patients with chronic heart failure. J Card Fail. 2011 Dec;17(12):982-9. doi: 10.1016/j.cardfail.2011.08.012. Epub 2011 Oct 6.