Clinical trial NCT02288819: Spot Urinary Analysis to Assess Loop Diuretic Efficiency in Stable Heart Failure
Official title: Diuretic Efficiency in Patients With Stable Heart Failure: Ion Excretion Capacity of the Kidneys (DIPSTICK) Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: loop diuretics
heart failure
natriuresis
urinary analysis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2014-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg)
timeFrame: 7 days after baseline
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 30 days after baseline
measure: Number of Participants Rehospitalized for Heart Failure
timeFrame: 30 days after baseline
measure: Number of Participants Requiring a Dose Increase in Loop Diuretics
timeFrame: 30 days after baseline
measure: Weight Change
timeFrame: 7 days after baseline
Other outcomes:
measure: Weight Change
timeFrame: 30 days after baseline
measure: Self-reported Orthopnea
timeFrame: 30 days after baseline
measure: Self-reported Lower Leg Edema
timeFrame: 30 days after baseline
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 30 days after baseline
measure: All-cause Mortality
timeFrame: 6 months after baseline
measure: Rehospitalization for Heart Failure
timeFrame: 6 months after baseline
measure: Dose Increase of Loop Diuretics
timeFrame: 6 months after baseline
measure: Weight Change
timeFrame: 7 days after baseline
measure: NYHA Functional Class
timeFrame: 30 days after baseline
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Wilfried Mullens, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziekenhuis Oost-Limburg
name: Frederik H Verbrugge, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martens P, Verbrugge FH, Boonen L, Nijst P, Dupont M, Mullens W. Value of routine investigations to predict loop diuretic down-titration success in stable heart failure. Int J Cardiol. 2018 Jan 1;250:171-175. doi: 10.1016/j.ijcard.2017.10.018. Epub 2017 Oct 6.
citation: Verbrugge FH, Martens P, Boonen L, Nijst P, Verhaert D, Noyens P, De Vusser P, Dupont M, Tang WHW, Mullens W. Loop diuretic down-titration in stable chronic heart failure is often achievable, especially when urinary chloride concentration is low. Acta Cardiol. 2018 Aug;73(4):335-341. doi: 10.1080/00015385.2017.1385152. Epub 2017 Oct 3.
citation: Boonen L, Verbrugge FH, Nijst P, Noyens P, De Vusser P, Verhaert D, Van Lierde J, Vrolix M, Dupont M, Mullens W. Subclinical volume overload in stable outpatients with chronic heart failure. Acta Cardiol. 2016 Jun;71(3):299-307. doi: 10.2143/AC.71.3.3152090. No abstract available.