Comparing the Effects of Conivaptan and Diuretics on Plasma Neurohormones and Renal Blood Flow in Patients With Chronic Congestive Heart Failure
Information source: Hennepin County Medical Center, Minneapolis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Conivaptan (Drug); Furosemide (Drug); Conivaptan and furosemide (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Hennepin County Medical Center, Minneapolis Official(s) and/or principal investigator(s):
Steven R Goldsmith, MD, Study Director, Affiliation: Hennepin County Medical Center, Minneapolis
Overall contact:
Shari Mackedanz, RN BSN, Phone: 612-347-5195, Email: shari.mackedanz@hcmed.org
Summary
The purpose of the study is to compare the effects of conivaptan and diuretics on renal
blood flow and neurohormones.
Clinical Details
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 design: Other, Randomized, Open Label, Crossover Assignment
Primary outcome: renal hemodynamics renal blood flow and glomerular filtration rate
Secondary outcome: measure plasma neurohormone levels
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Shari Mackedanz, RN BSN, Phone: 612-347-5195, Email: shari.mackedanz@hcmed.org
Hennepin county Medical Center, Minneapolis, Minnesota 55404, United States
Additional Information
Starting date: July 2009
Ending date: March 2010
Last updated: June 17, 2009
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