Loop Diuretics in Chronic Kidney Disease

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Furosemide

• Registration Number: NCT00478543
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

The purpose of this study is to verify the efficacy of diuretic therapy on blood pressure control and left ventricular mass in patients affected by chronic kidney disease

Detailed Description

In CKD, impairment of renal function causes fluid and sodium retention and consequently expansion of extracellular volume, which corresponds to about 5% of body weight in absence of peripheral edema. In particular, sodium retention increases exponentially as glomerular filtration rate declines and is of primary importance in the pathogenesis of hypertension. Therefore, reduction of salt intake in renal patients allows a better blood pressure control. Despite the evidence collected on the beneficial effects of salt restriction in CKD, compliance with dietary prescription is generally poor in patients followed up in the real world of clinical practice. In the presence of poor adherence to salt restriction, diuretics agents become the cornerstone of treatment of hypertension secondary to CKD. Disappointingly, nephrologists are reluctant to "adequately" use loop diuretics in their hypertensive CKD patients, probably because of the fear of side effects and of the amazing absence in medical literature of studies of middle-long term on diuretic efficacy. Therefore, the primary aim of this study is to evaluate efficacy and safety of loop diuretics on blood pressure control in patients affected by CKD.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-25
• Primary Completion: 2008-05
• Study Completion: 2008-07
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Chronic renal insufficiency in stage CKD 3 and 4 (GFR 60-15 ml/min/m2) estimated by Cockcroft-Gault formula corrected for body surface
• Systolic blood pressure >140 mmHg in treatment with at least 1 class of antihypertensive drugs
• Patients not in treatment from at least one month with loop diuretics

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Exclusion Criteria

• Loop diuretics treatment
• Variation of serum creatinine >30% in the last 3 months
• Steroid therapy and/or cytotoxic agents
• Edema syndromes (Nephrotic syndrome, cirrhosis, heart failure NYHA class 3 or 4)
• Neoplasia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diuretic	Furosemide	Furosemide

Primary Outcome Measures

Name	Time	Method
Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography	6 months and 1 year respectively

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions, ambulatory blood pressure measure control, body volumes evaluated by bioimpedance analysis, expense of time and resources in follow-up of patients	6 months

Trial Locations

Locations (1)

Nephrology Department, Second University of Naples; 🇮🇹 Naples, Italy