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Spot Urinary Analysis to Assess Loop Diuretic Efficiency in Stable Heart Failure

Information source: Hasselt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: Weight monitoring (Device); Loop diuretic downtitration (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Hasselt University

Official(s) and/or principal investigator(s):
Wilfried Mullens, M.D. Ph.D., Principal Investigator, Affiliation: Ziekenhuis Oost-Limburg
Frederik H Verbrugge, M.D. Ph.D., Principal Investigator, Affiliation: Ziekenhuis Oost-Limburg

Overall contact:
Frederik H Verbrugge, M.D. Ph.D., Phone: +32473924199, Email: frederik.verbrugge@zol.be

Summary

The primary objective of this study is to assess whether the urinary sodium/creatinine or chloride/creatinine ratio might predict successful downtitration of loop diuretics in patients with stable heart failure without clinical signs of volume overload. In addition, this study will provide information on loop diuretic efficiency and urinary electrolyte composition after intake of diuretics in stable outpatients with heart failure.

Clinical Details

Official title: Diuretic Efficiency in Patients With Stable Heart Failure: Ion Excretion Capacity of the Kidneys (DIPSTICK) Study

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Successful downtitration of loop diuretics (no weight increase >1,5 kg)

Secondary outcome:

All-cause mortality

Rehospitalization for heart failure

Dose increase of loop diuretics

Weight change

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient has a left ventricular ejection fraction <40% or has been previously

hospitalized with a primary diagnosis of heart failure

- Patient receives a daily maintenance dose of loop diuretics

Exclusion Criteria:

- Patient was hospitalized for heart failure <3 months before study inclusion

- The maintenance dose of loop diuretics was changed <3 months before study inclusion

- The maintenance dose of renin-angiotensin-aldosterone system blockers or beta-blocker

medication was changed <3 months before study inclusion

- Cardiac resynchronization therapy (CRT) was initiated <3 months before study

inclusion

- At the moment of inclusion, the patient has either one of the following signs of

volume overload: lower leg edema +2/4, ascites, lung congestion

- Patient is not able to measure his/her weight safely and correct at home

Locations and Contacts

Frederik H Verbrugge, M.D. Ph.D., Phone: +32473924199, Email: frederik.verbrugge@zol.be

Ziekenhuis Oost-Limburg, Genk, Limburg 3600, Belgium; Recruiting
Frederik H Verbrugge, M.D. Ph.D., Phone: +32473924199, Email: frederik.verbrugge@zol.be
Pieter Martens, M.D., Phone: +3289321516, Email: pieter_martens@icloud.com
Frederik H. Verbrugge, M.D. Ph.D., Principal Investigator
Petra Nijst, M.D., Sub-Investigator
Joris Penders, M.D. Ph.D., Sub-Investigator
Levinia Boonen, B.Sc., Sub-Investigator
Carmen Reynders, M.Sc., Sub-Investigator
Pieter Martens, M.D., Principal Investigator
Wilfried Mullens, M.D. Ph.D., Principal Investigator
Additional Information

Starting date: September 2014
Last updated: August 2, 2015

Page last updated: August 23, 2015

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