NCT00924014

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 18, 2009

Status Verified

June 1, 2009

Enrollment Period

5 months

First QC Date

June 17, 2009

Last Update Submit

June 17, 2009

Conditions

Heart Failure

Keywords

heart failure

Outcome Measures

Primary Outcomes (1)

  • renal hemodynamics renal blood flow and glomerular filtration rate

    measured on days 1, 2, 3

Secondary Outcomes (1)

  • measure plasma neurohormone levels

    predose, 1 hour and 4 hours post dose measured on day 1, 2, 3

Study Arms (3)

Conivaptan

ACTIVE COMPARATOR

Conivaptan will be given via IV bolus

Drug: Conivaptan

Furosemide

ACTIVE COMPARATOR

Furosemide will be given via IV bolus

Drug: Furosemide

conivaptan and furosemide

ACTIVE COMPARATOR

on day 3 subjects will receive both study drugs

Drug: Conivaptan and furosemide

Interventions

ConivaptanDRUG

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

Also known as: vaprisol
Conivaptan
FurosemideDRUG

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.

Also known as: Lasix
Furosemide
Conivaptan and furosemideDRUG

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

Also known as: vaprisol, lasix
conivaptan and furosemide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin county Medical Center

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

  • 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.

    PMID: 22123359DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

conivaptanFurosemide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Steven R Goldsmith, MD

    Hennepin County Medical Center, Minneapolis

    STUDY DIRECTOR

Central Study Contacts

Shari Mackedanz, RN BSN

CONTACT

612-347-5195shari.mackedanz@hcmed.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

June 18, 2009

Record last verified: 2009-06

Locations

US(1)