NCT00478543

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

2.7 years

First QC Date

May 24, 2007

Last Update Submit

February 3, 2009

Conditions

Chronic Kidney Disease

Keywords

Loop diureticsChronic Kidney DiseaseHypertensionBlood pressure controlLeft ventricular mass

Outcome Measures

Primary Outcomes (1)

  • Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography

    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

    6 months

Study Arms (1)

Diuretic

EXPERIMENTAL

Furosemide

Drug: Furosemide

Interventions

FurosemideDRUG
Diuretic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Department, Second University of Naples

Naples, 80138, Italy

Location

Related Publications (3)

  • 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.

    PMID: 15112168BACKGROUND

  • 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.

    PMID: 16395261BACKGROUND

  • 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.

    PMID: 17035939BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertension

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Giuseppe Conte, Professor

    University of Campania Luigi Vanvitelli

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 25, 2007

Study Start

September 1, 2005

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

IT(1)