Loop Diuretics in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Furosemide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Loop diuretics, Chronic Kidney Disease, Hypertension, Blood pressure control, Left ventricular mass
Eligibility 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
Sites / Locations
- Nephrology Department, Second University of Naples
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diuretic
Arm Description
Furosemide
Outcomes
Primary Outcome Measures
Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography
Secondary Outcome Measures
Adverse drug reactions, ambulatory blood pressure measure control, body volumes evaluated by bioimpedance analysis, expense of time and resources in follow-up of patients
Full Information
NCT ID
NCT00478543
First Posted
May 24, 2007
Last Updated
February 3, 2009
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT00478543
Brief Title
Loop Diuretics in Chronic Kidney Disease
Official Title
Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Loop diuretics, Chronic Kidney Disease, Hypertension, Blood pressure control, Left ventricular mass
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diuretic
Arm Type
Experimental
Arm Description
Furosemide
Intervention Type
Drug
Intervention Name(s)
Furosemide
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Conte, Professor
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Study Chair
Facility Information:
Facility Name
Nephrology Department, Second University of Naples
City
Naples
ZIP/Postal Code
80138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
15112168
Citation
De Nicola L, Minutolo R, Bellizzi V, Zoccali C, Cianciaruso B, Andreucci VE, Fuiano G, Conte G; investigators of the TArget Blood Pressure LEvels in Chronic Kidney Disease (TABLE in CKD) Study Group. Achievement of target blood pressure levels in chronic kidney disease: a salty question? Am J Kidney Dis. 2004 May;43(5):782-95. doi: 10.1053/j.ajkd.2004.01.009.
Results Reference
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PubMed Identifier
16395261
Citation
De Nicola L, Minutolo R, Chiodini P, Zoccali C, Castellino P, Donadio C, Strippoli M, Casino F, Giannattasio M, Petrarulo F, Virgilio M, Laraia E, Di Iorio BR, Savica V, Conte G; TArget Blood Pressure LEvels in Chronic Kidney Disease (TABLE in CKD) Study Group. Global approach to cardiovascular risk in chronic kidney disease: reality and opportunities for intervention. Kidney Int. 2006 Feb;69(3):538-45. doi: 10.1038/sj.ki.5000085.
Results Reference
background
PubMed Identifier
17035939
Citation
Bellizzi V, Di Iorio BR, De Nicola L, Minutolo R, Zamboli P, Trucillo P, Catapano F, Cristofano C, Scalfi L, Conte G; ERIKA Study-group. Very low protein diet supplemented with ketoanalogs improves blood pressure control in chronic kidney disease. Kidney Int. 2007 Feb;71(3):245-51. doi: 10.1038/sj.ki.5001955. Epub 2006 Oct 11.
Results Reference
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Loop Diuretics in Chronic Kidney Disease
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