Loop Diuretics in Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT00478543
First received: May 24, 2007
Last updated: February 3, 2009
Last verified: February 2009

May 24, 2007
February 3, 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 ] [ Designated as safety issue: No ]
Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography [ Time Frame: 6 months and 1 year respectively ]
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 ] [ Designated as safety issue: Yes ]
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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00478543
LD1-22052007
No
Giuseppe Conte, Chair of Nephrology Second University of Naples
Second University of Naples
Not Provided
Study Chair: Giuseppe Conte, Professor Second University of Naples
Second University of Naples
February 2009

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