NCT01836809

Brief Summary

The prevalence of renal dysfunction after implantation of the artificial heart is high. The infusion of exogenous B-type natriuretic peptide (BNP) after implantation of the total artificial heart (TAH) improves renal function in a sustained manner. The renal protective and hormone-modulating effects of nesiritide may be enhanced with ventriculectomy compared to heart failure surgery that leaves the native myocardium intact. The goal of this project is to determine the renal protective effects of nesiritide after implantation of a mechanical device.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 18, 2014

Completed
Last Updated

February 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

April 17, 2013

Results QC Date

July 7, 2014

Last Update Submit

January 13, 2016

Conditions

Congestive Heart FailureCardiorenal Syndrome

Keywords

Total Artificial HeartLeft Ventricular Assist DeviceNatriuretic peptidesHeart FailureCardiorenal Syndrome

Outcome Measures

Primary Outcomes (2)

  • Glomerular Filtration Rate

    46 hours

  • Renal Plasma Flow

    46 Hours

Secondary Outcomes (4)

  • Need for Hemodialysis/Renal Replacement Therapy

    90 days

  • Urine Output

    46 Hours

  • Time to Renal Failure

    46 Hours

  • Total Diuretic Requirement

    46 Hours

Study Arms (4)

Total Artificial Heart

EXPERIMENTAL

Nesiritide

Drug: nesiritide

Total Artificial Heart: Placebo

PLACEBO COMPARATOR

Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo

Drug: placebo

LVAD: Nesiritide

ACTIVE COMPARATOR

Active arm of the LVAD group

Drug: nesiritide

LVAD: Placebo

PLACEBO COMPARATOR

Control arm for subjects receiving LVAD and randomized to placebo

Drug: placebo

Interventions

nesiritideDRUG

nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours.

Also known as: Natrecor
LVAD: NesiritideTotal Artificial Heart
placeboDRUG

placebo bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours.

LVAD: PlaceboTotal Artificial Heart: Placebo

Eligibility Criteria

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

You may qualify if:

  • Implanted with a total artificial heart (CardioWest) or Left ventricular assist device (HeartMate II)
  • Age \> 18 years

You may not qualify if:

  • Previous calcineurin inhibitor (CNI) exposure
  • Hemodialysis prior to device implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Heart FailureCardio-Renal Syndrome

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Limitations and Caveats

Enrollment closed. Total Artificial Hearts (TAH) are rarely done as advances with Left Ventricular Assist Devices have improved. We were unable to meet enrollment goal based on the funding timeline due to the lack of TAH's for comparison to LVAD.

Results Point of Contact

Title
Keyur Shah, MD
Organization
Virginia Commonwealth University
kshah@mcvh-vcu.edu
804-828-4571

Study Officials

  • Keyur B. Shah, MD

    Virginia Commonwealth University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 22, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

February 8, 2016

Results First Posted

August 18, 2014

Record last verified: 2016-01

Locations

US(1)