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

June 17, 2009 updated by: Hennepin County Medical Center, Minneapolis

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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:
  • lasix
  • vaprisol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin County Medical Center, Minneapolis

Collaborators

Astellas Pharma Inc

Investigators

  • Study Director: Steven R Goldsmith, MD, Hennepin County Medical Center, Minneapolis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

March 1, 2010

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (ESTIMATE)

June 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 18, 2009

Last Update Submitted That Met QC Criteria

June 17, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)
  • IND 104, 334

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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