Loop Diuretics in Chronic Kidney Disease
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 24, 2007 | ||||
| Last Updated Date | February 3, 2009 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography [ Time Frame: 6 months and 1 year respectively ] | ||||
| Change History | Complete list of historical versions of study NCT00478543 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Loop Diuretics in Chronic Kidney Disease | ||||
| Official Title ICMJE | Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Chronic Kidney Disease | ||||
| Intervention ICMJE | Drug: Furosemide | ||||
| Study Arm (s) | Experimental: Diuretic
Furosemide
Intervention: Drug: Furosemide |
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00478543 | ||||
| Other Study ID Numbers ICMJE | LD1-22052007 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Giuseppe Conte, Chair of Nephrology Second University of Naples | ||||
| Study Sponsor ICMJE | Second University of Naples | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Second University of Naples | ||||
| Verification Date | February 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||