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Loop Diuretics in Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478543
First Posted: May 25, 2007
Last Update Posted: February 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Campania "Luigi Vanvitelli"
May 24, 2007
May 25, 2007
February 4, 2009
September 2005
May 2008   (Final data collection date for primary outcome measure)
Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography [ Time Frame: 6 months and 1 year respectively ]
Same as current
Complete list of historical versions of study NCT00478543 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Loop Diuretics in Chronic Kidney Disease
Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease
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
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Kidney Disease
Drug: Furosemide
Experimental: Diuretic
Furosemide
Intervention: Drug: Furosemide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2008
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00478543
LD1-22052007
No
Not Provided
Not Provided
Giuseppe Conte, Chair of Nephrology Second University of Naples
University of Campania "Luigi Vanvitelli"
Not Provided
Study Chair: Giuseppe Conte, Professor University of Campania "Luigi Vanvitelli"
University of Campania "Luigi Vanvitelli"
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP