search
Back to results

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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Weight monitoring
Loop diuretic downtitration
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring loop diuretics, heart failure, natriuresis, urinary analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Loop diuretic downtitration

Arm Description

Scheduled downtitration of maintenance loop diuretic dose while monitoring weight

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All-cause Mortality
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.
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.
Weight Change
Weight change [kg] 7 days after baseline compared to baseline weight.

Full Information

First Posted
October 23, 2014
Last Updated
January 15, 2019
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
search

1. Study Identification

Unique Protocol Identification Number
NCT02288819
Brief Title
Spot Urinary Analysis to Assess Loop Diuretic Efficiency in Stable Heart Failure
Acronym
DIPSTICK
Official Title
Diuretic Efficiency in Patients With Stable Heart Failure: Ion Excretion Capacity of the Kidneys (DIPSTICK) Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment and a lack of funding to complete further follow-up
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
loop diuretics, heart failure, natriuresis, urinary analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loop diuretic downtitration
Arm Type
Experimental
Arm Description
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Intervention Type
Device
Intervention Name(s)
Weight monitoring
Intervention Description
The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Intervention Type
Drug
Intervention Name(s)
Loop diuretic downtitration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg)
Description
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.
Time Frame
7 days after baseline
Secondary Outcome Measure Information:
Title
All-cause Mortality
Time Frame
30 days after baseline
Title
Number of Participants Rehospitalized for Heart Failure
Description
Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.
Time Frame
30 days after baseline
Title
Number of Participants Requiring a Dose Increase in Loop Diuretics
Description
Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.
Time Frame
30 days after baseline
Title
Weight Change
Description
Weight change [kg] 7 days after baseline compared to baseline weight.
Time Frame
7 days after baseline
Other Pre-specified Outcome Measures:
Title
Weight Change
Description
Weight change [kg] 30 days after baseline compared to weight 7 days after baseline (after achieving the final dose of loop diuretics).
Time Frame
30 days after baseline
Title
Self-reported Orthopnea
Description
The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.
Time Frame
30 days after baseline
Title
Self-reported Lower Leg Edema
Description
The patient is contacted by phone 30 days after baseline and asked for self-reported presence of lower leg edema.
Time Frame
30 days after baseline
Title
New York Heart Association (NYHA) Functional Class
Description
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.
Time Frame
30 days after baseline
Title
All-cause Mortality
Time Frame
6 months after baseline
Title
Rehospitalization for Heart Failure
Description
Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.
Time Frame
6 months after baseline
Title
Dose Increase of Loop Diuretics
Description
Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.
Time Frame
6 months after baseline
Title
Weight Change
Description
Weight change [kg] 7 days after baseline compared to baseline weight.
Time Frame
7 days after baseline
Title
NYHA Functional Class
Description
The patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator.
Time Frame
30 days after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried Mullens, M.D. Ph.D.
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederik H Verbrugge, M.D. Ph.D.
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29056238
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.
Results Reference
result
PubMed Identifier
28971753
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.
Results Reference
result
PubMed Identifier
27594125
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs