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Completed

NCT Number: NCT00478543

Loop Diuretics in 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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 25, 2007
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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