Heart Failure NYHA Class III Clinical Trial
— DRAINOfficial title:
Diuretic Treatment in High Risk Decompensated Advanced Heart Failure. Bolus Intermittent Versus Continuous Infusion of Furosemide: a Randomized Controlled Trial.
Verified date | July 2018 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 22, 2017 |
Est. primary completion date | December 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Simone Frea | Torino | To |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from congestion | 72 hours after randomization | ||
Secondary | Worsening of renal function | Increase in creatinine value > 0.3 mg/dl or increase > 1.5 times | 72 hours after randomization | |
Secondary | Worsening or persistent HF at 72 h | Need to increase the dose of inotropes or diuretics | 72 hours after randomization | |
Secondary | Change in body weight | 72 hours after randomization | ||
Secondary | Laboratory data variations in NTproBNP | 72 hours after randomization | ||
Secondary | Treatment failure | Composed by the following events: persistence of congestion, need to increase diuretic treatment, need of renal replacement treatment | 72 hours after randomization | |
Secondary | Weight differences based on diuretic dose unity | 72 hours after randomization |
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