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Loop Diuretics in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00478543
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : February 4, 2009
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Furosemide Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease
Study Start Date : September 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Furosemide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diuretic
Furosemide
Drug: Furosemide



Primary Outcome Measures :
  1. Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography [ Time Frame: 6 months and 1 year respectively ]

Secondary Outcome Measures :
  1. Adverse drug reactions, ambulatory blood pressure measure control, body volumes evaluated by bioimpedance analysis, expense of time and resources in follow-up of patients [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478543


Locations
Italy
Nephrology Department, Second University of Naples
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
Study Chair: Giuseppe Conte, Professor University of Campania "Luigi Vanvitelli"

Publications:
Responsible Party: Giuseppe Conte, Chair of Nephrology Second University of Naples
ClinicalTrials.gov Identifier: NCT00478543     History of Changes
Other Study ID Numbers: LD1-22052007
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by University of Campania "Luigi Vanvitelli":
Loop diuretics
Chronic Kidney Disease
Hypertension
Blood pressure control
Left ventricular mass

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Furosemide
Diuretics
Sodium Potassium Chloride Symporter Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action