Loop Diuretics in Chronic Kidney Disease
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease |
Drug: Furosemide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease |
- 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 ]
- 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 ]
| Enrollment: | 40 |
| Study Start Date: | September 2005 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Diuretic
Furosemide
|
Drug: Furosemide |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Italy | |
| Nephrology Department, Second University of Naples | |
| Naples, Italy, 80138 | |
| Study Chair: | Giuseppe Conte, Professor | Second University of Naples |
More Information
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 |
| Study First Received: | May 24, 2007 |
| Last Updated: | February 3, 2009 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Second University of Naples:
|
Loop diuretics Chronic Kidney Disease Hypertension Blood pressure control Left ventricular mass |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency Diuretics Furosemide Sodium Potassium Chloride Symporter Inhibitors |
Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013