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

NCT02288819 | Terminated Results DMC

• 1 other identifier: ZOL-DIPSTICK
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

loop diuretics; heart failure; natriuresis; urinary analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• All-cause Mortality

  30 days after baseline

• Number of Participants Rehospitalized for Heart Failure

  30 days after baseline

• Number of Participants Requiring a Dose Increase in Loop Diuretics

  30 days after baseline

• Weight Change

  7 days after baseline

Other Outcomes (9)

• Weight Change

  30 days after baseline

• Self-reported Orthopnea

  30 days after baseline

• Self-reported Lower Leg Edema

  30 days after baseline

Study Arms (1)

Loop diuretic downtitration

EXPERIMENTAL

Scheduled downtitration of maintenance loop diuretic dose while monitoring weight

Device: Weight monitoring; Drug: Loop diuretic downtitration

Interventions

Weight monitoring DEVICE

The body weight of patients is measured each morning in identical conditions on the same balance during 7 days

Loop diuretic downtitration

Loop diuretic downtitration DRUG

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.

Loop diuretic downtitration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is not able to measure his/her weight safely and correct at home

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Related Publications (3)

• 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.

  PMID: 29056238 RESULT

• 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.

  PMID: 28971753 RESULT

• 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.

  PMID: 27594125 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Frederik Verbrugge
• Organization: Ziekenhuis Oost-Limburg

frederik.verbrugge@zol.be

0473924199

Study Officials

• Wilfried Mullens, M.D. Ph.D.

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

• Frederik H Verbrugge, M.D. Ph.D.

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 11, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)