NCT03592836

Brief Summary

Loop diuretics are the main therapy for decongestion of patients with advanced acute heart failure. However, these patients often develop diuretic-resistance or even diuretic-refractoriness. In order to overcome such resistance to diuretic, the clinician can increase the dose of furosemide, or change the way of administration (continuous infusion versus boluses) or associate a different class of diuretics (thiazide diuretics, K+-sparing diuretics) up to the addition of low doses of inotropic agents to improve renal perfusion. At the present time there is no evidence in literature in advanced acute heart failure patients about the superiority of the treatment with furosemide in continuous infusion or in intermittent boluses. The aim of the study was to evaluate the efficacy of furosemide in boluses versus continuous infusion in advanced acute heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2013

Longer than P75 for phase_3

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
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

4.6 years

First QC Date

June 18, 2018

Last Update Submit

July 9, 2018

Conditions

Heart Failure NYHA Class IIIHeart Failure NYHA Class IV

Outcome Measures

Primary Outcomes (1)

  • Freedom from congestion

    72 hours after randomization

Secondary Outcomes (6)

  • Worsening of renal function

    72 hours after randomization

  • Worsening or persistent HF at 72 h

    72 hours after randomization

  • Change in body weight

    72 hours after randomization

  • Laboratory data variations in NTproBNP

    72 hours after randomization

  • Treatment failure

    72 hours after randomization

  • +1 more secondary outcomes

Study Arms (2)

Continuous infusion of loop diuretics

ACTIVE COMPARATOR

Furosemide continuous infusion: 125 or 250 mg die

Drug: Loop Diuretics

Intermittent infusion of loop diuretics

ACTIVE COMPARATOR

Furosemide bolus intermittent: 125 or 250 mg die

Drug: Loop Diuretics

Interventions

Loop DiureticsDRUG

intravenous administration of diuretics

Also known as: furosemide
Continuous infusion of loop diureticsIntermittent infusion of loop diuretics

Eligibility Criteria

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

You may qualify if:

  • Advanced heart failure
  • WET ≥ 12
  • Systolic blood pressure ≤ 110 mmHg
  • Serum sodium ≤ 135 mEq/L
  • Left systolic ventricular insufficiency (FE \< 35%) note for at least 6 months
  • Class NYHA III-IV despite medical treatment maximal

You may not qualify if:

  • Acute coronary syndrome
  • Shock cardiogenic
  • Chronic renal failure stage V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simone Frea

Torino, To, 10126, Italy

Location

Related Publications (1)

  • Frea S, Pidello S, Volpe A, Canavosio FG, Galluzzo A, Bovolo V, Camarda A, Golzio PG, D'Ascenzo F, Bergerone S, Rinaldi M, Gaita F. Diuretic treatment in high-risk acute decompensation of advanced chronic heart failure-bolus intermittent vs. continuous infusion of furosemide: a randomized controlled trial. Clin Res Cardiol. 2020 Apr;109(4):417-425. doi: 10.1007/s00392-019-01521-y. Epub 2019 Jun 29.

    PMID: 31256261DERIVED

MeSH Terms

Interventions

Sodium Potassium Chloride Symporter InhibitorsFurosemide

Intervention Hierarchy (Ancestors)

Membrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesDiureticsNatriuretic AgentsPhysiological Effects of DrugsSulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Simone Frea, MD

    A.O.U. Città della Salute e della Scienza di Torino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Cardiologist

Study Record Dates

First Submitted

June 18, 2018

First Posted

July 19, 2018

Study Start

May 1, 2013

Primary Completion

December 22, 2017

Study Completion

December 22, 2017

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

IT(1)