Clinical trial NCT03592836: Diuretic Response in Advanced Heart Failure: Bolus Intermittent vs Continuous INfusion
Official title: Diuretic Treatment in High Risk Decompensated Advanced Heart Failure. Bolus Intermittent Versus Continuous Infusion of Furosemide: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Freedom from congestion
timeFrame: 72 hours after randomization
Secondary outcomes:
measure: Worsening of renal function
timeFrame: 72 hours after randomization
measure: Worsening or persistent HF at 72 h
timeFrame: 72 hours after randomization
measure: Change in body weight
timeFrame: 72 hours after randomization
measure: Laboratory data variations in NTproBNP
timeFrame: 72 hours after randomization
measure: Treatment failure
timeFrame: 72 hours after randomization
measure: Weight differences based on diuretic dose unity
timeFrame: 72 hours after randomization
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Simone Frea
state: To
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza di Torino
name: Simone Frea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.