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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Hennepin County Medical Center, Minneapolis.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
Hennepin County Medical Center, Minneapolis
ClinicalTrials.gov Identifier:
NCT00924014
First received: June 17, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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


Condition Intervention
Heart Failure
Drug: Conivaptan
Drug: Furosemide
Drug: Conivaptan and furosemide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparative Effects of Conivaptan and Loop Diuretics on Plasma Neurohormones and Systemic and Renal Hemodynamics in Subjects With Chronic Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Hennepin County Medical Center, Minneapolis:

Primary Outcome Measures:
  • renal hemodynamics renal blood flow and glomerular filtration rate [ Time Frame: measured on days 1, 2, 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • measure plasma neurohormone levels [ Time Frame: predose, 1 hour and 4 hours post dose measured on day 1, 2, 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: July 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conivaptan
Conivaptan will be given via IV bolus
Drug: Conivaptan
Conivaptan 20 mg IV bolus followed by a 4 hour infusion at 1.2 mg/hr
Other Name: vaprisol
Active Comparator: Furosemide
Furosemide will be given via IV bolus
Drug: Furosemide
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.
Other Name: Lasix
Active Comparator: conivaptan and furosemide
on day 3 subjects will receive both study drugs
Drug: Conivaptan and furosemide
Furosemide bolus first; conivaptan 20 mg IV bolus/infusion at 1.2 mg/hour for a total of 4 hours
Other Names:
  • vaprisol
  • lasix

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924014

Contacts
Contact: Shari Mackedanz, RN BSN 612-347-5195 shari.mackedanz@hcmed.org

Locations
United States, Minnesota
Hennepin county Medical Center Not yet recruiting
Minneapolis, Minnesota, United States, 55404
Principal Investigator: Steven R Goldsmith, MD         
Sponsors and Collaborators
Hennepin County Medical Center, Minneapolis
Astellas Pharma Inc
Investigators
Study Director: Steven R Goldsmith, MD Hennepin County Medical Center, Minneapolis
  More Information

No publications provided by Hennepin County Medical Center, Minneapolis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven R. Goldsmith, Hennepin County Medical Center
ClinicalTrials.gov Identifier: NCT00924014     History of Changes
Other Study ID Numbers: 001, IND 104, 334
Study First Received: June 17, 2009
Last Updated: June 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Hennepin County Medical Center, Minneapolis:
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Diuretics
Furosemide
Neurotransmitter Agents
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014