NCT01863511

Brief Summary

For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal, less neurohormonal stimulation and greater sodium removal.However it is associated with increased costs, line complications, and relative immobility during treatment. Tolvaptan in addition to diuretic therapy has been shown to improve the amount of volume removed compared to diuretic alone. The study proposes to compare the strategy of adding tolvaptan to usual care with ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients. Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in:

  • greater volume and weight reduction compared with usual care
  • similar efficacy outcomes compared with ultrafiltration, with less complications of therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

February 1, 2015

Enrollment Period

2.6 years

First QC Date

May 20, 2013

Last Update Submit

January 27, 2016

Conditions

Acute Decompensated Heart Failure

Keywords

Treatment options for acute decompensated heart failureUltrafiltrationtolvaptan

Outcome Measures

Primary Outcomes (1)

  • Net change in weight

    day 1,2,3,4,5

Secondary Outcomes (9)

  • net volume loss

    day 1,2,3,4,5

  • urinary NGAL

    Day 1,2,3,4,5

  • dyspnea score

    baseline and day 5

  • BNP change from admission to discharge

    baseline and day 5

  • serum creatinine change

    Day 1,2,3,4,5

  • +4 more secondary outcomes

Other Outcomes (2)

  • nursing intensity

    day 1,2,3,4,5

  • peripheral vs. central access, number of filters used, complications of heparin use

    day 1,2,3,4,5

Study Arms (3)

usual care

ACTIVE COMPARATOR

IV loop diuretics

Drug: loop diuretic

Usual care plus tolvaptan

ACTIVE COMPARATOR

IV loop diuretic plus Tolvaptan 30 mg orally once daily

Drug: loop diureticDrug: tolvaptan

ultrafiltration

ACTIVE COMPARATOR

Volume removal through a brachial line extended length catheter or a quad lumen catheter via the internal jugular vein

Procedure: ultrafiltration

Interventions

loop diureticDRUG
Usual care plus tolvaptanusual care
tolvaptanDRUG
Usual care plus tolvaptan
ultrafiltrationPROCEDURE
ultrafiltration

Eligibility Criteria

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

You may qualify if:

  • of 3 physical exam findings of volume overload (rales, JVP over 5 cm and edema)
  • BNP over 300
  • no contraindication to ultrafiltration (line insertion, heparin use)

You may not qualify if:

  • serum creatinine \> 3mg/dL or Na \> 145
  • inotrope or vasopressor dependency
  • active infection, including urinary tract
  • resynchronization therapy or coronary intervention in past 30 days
  • life expectancy less than 6 months
  • hypertrophic obstructive cardiomyopathy with peak resting gradient \> 20 mmHg
  • IV contrast or NSAID use in the past 1 week (uNGAL related requirement)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45011, United States

Location

Related Publications (1)

  • Srivastava M, Harrison N, Caetano AFS, Tan AR, Law M. Ultrafiltration for acute heart failure. Cochrane Database Syst Rev. 2022 Jan 21;1(1):CD013593. doi: 10.1002/14651858.CD013593.pub2.

    PMID: 35061249DERIVED

MeSH Terms

Interventions

Sodium Potassium Chloride Symporter InhibitorsTolvaptanUltrafiltration

Intervention Hierarchy (Ancestors)

Membrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesDiureticsNatriuretic AgentsPhysiological Effects of DrugsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsExtracorporeal CirculationSurgical Procedures, OperativeFiltrationChemistry Techniques, AnalyticalInvestigative TechniquesPhysical PhenomenaChemical Phenomena

Study Officials

  • Eugene S Chung, MD

    The Christ Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eugene S. Chung MD, FACC

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 29, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 28, 2016

Record last verified: 2015-02

Locations

US(1)