Heart FailureDIPSTICKNCT02288819

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

A study testing Weight monitoring and Loop diuretic downtitration in people with Heart Failure, run by Hasselt University at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Weight monitoring and Loop diuretic downtitration
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteBelgium
Study dates: Sep 2014to Apr 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Ziekenhuis Oost-Limburg
Genk, Limburg, 3600

Other trials in Belgium

About this study

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

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.

Conditions: Heart Failure
Being tested: Weight monitoring, Loop diuretic downtitration
Keywords: loop diuretics, heart failure, natriuresis, urinary analysis
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Weight monitoringDevice
The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitrationDrug
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.

Study groups in NCT02288819
Study group	Role	What they receive
Loop diuretic downtitration	Experimental	Scheduled downtitration of maintenance loop diuretic dose while monitoring weight Receives: Device: Weight monitoring; Drug: Loop diuretic downtitration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 days after baseline

Secondary outcomes (4)

All-cause Mortality
Measured: 30 days after baseline
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.
Measured: 30 days after baseline
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.
Measured: 30 days after baseline
Weight Change
Weight change [kg] 7 days after baseline compared to baseline weight.
Measured: 7 days after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Apr 2016

First posted11 Nov 2014 (estimated)
Study startSep 2014
Primary completionMar 2016
Study completionApr 2016

Why it stopped: Slow recruitment and a lack of funding to complete further follow-up

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02288819
Sponsor's protocol ID: ZOL-DIPSTICK
Acronym: DIPSTICK
Status last verified: Jan 2019
First submitted: 23 Oct 2014
Last updated: 16 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 29056238
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.
PubMed 28971753
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.
PubMed 27594125

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diuretic Efficiency in Patients With Stable Heart Failure: Ion Excretion Capacity of the Kidneys (DIPSTICK) Study
ClinicalTrials.gov ID: NCT02288819
Acronym / sponsor ID: DIPSTICK / ZOL-DIPSTICK
Conditions: Heart Failure
Keywords: loop diuretics, heart failure, natriuresis, urinary analysis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment and a lack of funding to complete further follow-up
Enrolment: 50 participants (actual)
Lead sponsor: Hasselt UniversityUniversity, hospital or other
Collaborators: Ziekenhuis Oost-Limburg
Study start: Sep 2014
Primary completion: Mar 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 11 Nov 2014 (estimated)
Results: Posted 16 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Loop diuretic downtitration	Experimental	Device: Weight monitoring, Drug: Loop diuretic downtitrationScheduled downtitration of maintenance loop diuretic dose while monitoring weight

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Weight monitoringThe body weight of patients is measured each morning in identical conditions on the same balance during 7 days	Device	Loop diuretic downtitration
Loop diuretic downtitrationThe 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.	Drug	Loop diuretic downtitration

Primary outcome

Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg)
Time frame: 7 days after baseline
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.

4 secondary outcomes

All-cause Mortality
Time frame: 30 days after baseline
Number of Participants Rehospitalized for Heart Failure
Time frame: 30 days after baseline
Number of Participants Requiring a Dose Increase in Loop Diuretics
Time frame: 30 days after baseline
Weight Change
Time frame: 7 days after baseline

Results and safety

Results posted to the registry on 16 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Loop Diuretic Downtitration	50	50

Primary outcome: Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg)

Time frame: 7 days after baseline. Count of participants. Unit: Participants

Measure	Loop Diuretic Downtitration n = 50
Value	37

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loop Diuretic Downtitration	1 of 50 (2%)	0 of 50 (0%)	1 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29056238Martens 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 publication: PubMed 28971753Verbrugge 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 publication: PubMed 27594125Boonen 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.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wilfried Mullens, M.D. Ph.D. principal investigator

Ziekenhuis Oost-Limburg

Frederik H Verbrugge, M.D. Ph.D. principal investigator

Ziekenhuis Oost-Limburg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Weight monitoring and Loop diuretic downtitration in people with Heart Failure, run by Hasselt University at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg) (time frame: 7 days after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02288819, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.