Clinical trial NCT00478543: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: Loop diuretics
Chronic Kidney Disease
Hypertension
Blood pressure control
Left ventricular mass
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2007-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography
timeFrame: 6 months and 1 year respectively
Secondary outcomes:
measure: Adverse drug reactions, ambulatory blood pressure measure control, body volumes evaluated by bioimpedance analysis, expense of time and resources in follow-up of patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Nephrology Department, Second University of Naples
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Giuseppe Conte, Professor
role: STUDY_CHAIR
References:
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.
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.
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.