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

Heart Failure Clinical Trial

— DIPSTICK  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02288819
• Other study ID #: ZOL-DIPSTICK
• Status: Terminated
• Phase: N/A
• Start date: September 2014
• Est. completion date: April 2016

Study information

• Verified date: January 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Weight monitoring
The body weight of patients is measured each morning in identical conditions on the same balance during 7 days

Drug:
• Loop diuretic downtitration
The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days. In case of a total daily maintenance dose =40 mg furosemide OR =1 mg bumetanide OR =20 mg torsemide, the loop diuretic is completely stopped. In case of a total daily maintenance dose >40 mg furosemide OR >1 mg bumetanide OR >20 mg torsemide, the loop diuretic dose is halved.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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.71.3.31520 — View 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 O — View 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 Car — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight Change	Weight change [kg] 30 days after baseline compared to weight 7 days after baseline (after achieving the final dose of loop diuretics).	30 days after baseline
Other	Self-reported Orthopnea	The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.	30 days after baseline
Other	Self-reported Lower Leg Edema	The patient is contacted by phone 30 days after baseline and asked for self-reported presence of lower leg edema.	30 days after baseline
Other	New York Heart Association (NYHA) Functional Class	NYHA class is a semi-quantitative measurement of functional capacity on a scale from 1 to 4: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).; Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).; Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.; Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.; For the purpose of this outcome parameter, the patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator.	30 days after baseline
Other	All-cause Mortality		6 months after baseline
Other	Rehospitalization for Heart Failure	Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.	6 months after baseline
Other	Dose Increase of Loop Diuretics	Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.	6 months after baseline
Other	Weight Change	Weight change [kg] 7 days after baseline compared to baseline weight.	7 days after baseline
Other	NYHA Functional Class	The patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator.	30 days after baseline
Primary	Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg)	After baseline evaluation, loop diuretics are temporarily downtitrated or stopped for 7 consecutive days. The patient is instructed to measure his/her weight in the morning of these days, immediately after waking up, on the same balance. In case of weight increase >1,5 kg, the original dose of diuretics is restored. To check this, patients are contacted by phone after 3 and 7 days. If the patient has not gained >1,5 kg of weight after 7 days, loop diuretics are considered to be successfully downtitrated.	7 days after baseline
Secondary	All-cause Mortality		30 days after baseline
Secondary	Number of Participants Rehospitalized for Heart Failure	Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.	30 days after baseline
Secondary	Number of Participants Requiring a Dose Increase in Loop Diuretics	Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.	30 days after baseline
Secondary	Weight Change	Weight change [kg] 7 days after baseline compared to baseline weight.	7 days after baseline