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 mortalityRehospitalization 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
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