Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Conditions
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.
Interventions
DRUGLoop Diuretics
intravenous administration of diuretics
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from congestion | 72 hours after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worsening of renal function | 72 hours after randomization | Increase in creatinine value \> 0.3 mg/dl or increase \> 1.5 times |
| Worsening or persistent HF at 72 h | 72 hours after randomization | Need to increase the dose of inotropes or diuretics |
| Change in body weight | 72 hours after randomization | — |
| Laboratory data variations in NTproBNP | 72 hours after randomization | — |
| Treatment failure | 72 hours after randomization | Composed by the following events: persistence of congestion, need to increase diuretic treatment, need of renal replacement treatment |
| Weight differences based on diuretic dose unity | 72 hours after randomization | — |
Countries
Italy
Outcome results
None listed