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Slow recruitment and a lack of funding to complete further follow-up
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| Name | Class |
|---|---|
| Ziekenhuis Oost-Limburg | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loop diuretic downtitration | Experimental | Scheduled downtitration of maintenance loop diuretic dose while monitoring weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight monitoring | Device | The body weight of patients is measured each morning in identical conditions on the same balance during 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Self-reported Orthopnea |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried Mullens, M.D. Ph.D. | Ziekenhuis Oost-Limburg | Principal Investigator |
| Frederik H Verbrugge, M.D. Ph.D. | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29056238 | Result | 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. | |
| 28971753 | 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. |
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Outpatient cardiology clinic of a single tertiary centre (Ziekenhuis Oost-Limburg, Genk, Belgium) between December, 2014, and February, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Loop Diuretic Downtitration | Scheduled downtitration of maintenance loop diuretic dose while monitoring weight Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loop Diuretic Downtitration | Scheduled downtitration of maintenance loop diuretic dose while monitoring weight Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 7 days after baseline |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loop Diuretic Downtitration | Scheduled downtitration of maintenance loop diuretic dose while monitoring weight Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure readmission | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frederik Verbrugge | Ziekenhuis Oost-Limburg | 0473924199 | +32 | frederik.verbrugge@zol.be |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |
|
| 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. | 30 days after baseline |
| Weight Change | Weight change [kg] 7 days after baseline compared to baseline weight. | 7 days after baseline |
The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.
| 30 days after baseline |
| 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 |
| New York Heart Association (NYHA) Functional Class | NYHA class is a semi-quantitative measurement of functional capacity on a scale from 1 to 4:
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 |
| All-cause Mortality | 6 months after baseline |
| 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 |
| 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 |
| Weight Change | Weight change [kg] 7 days after baseline compared to baseline weight. | 7 days after baseline |
| 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 |
| 27594125 | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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| Secondary | All-cause Mortality | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 30 days after baseline |
|
|
|
| Secondary | Weight Change | Weight change [kg] 7 days after baseline compared to baseline weight. | Posted | Mean | Standard Deviation | kg | 7 days after baseline |
|
|
|
| Other Pre-specified | Weight Change | Weight change [kg] 30 days after baseline compared to weight 7 days after baseline (after achieving the final dose of loop diuretics). | Posted | Mean | Standard Deviation | kg | 30 days after baseline |
|
|
|
| Other Pre-specified | Self-reported Orthopnea | The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea. | 1 patient who died before the 30-day follow-up could not be assessed | Posted | Count of Participants | Participants | 30 days after baseline |
|
|
|
| Other Pre-specified | 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. | 1 patient who died before the 30-day follow-up could not be assessed | Posted | Count of Participants | Participants | 30 days after baseline |
|
|
|
| Other Pre-specified | New York Heart Association (NYHA) Functional Class | NYHA class is a semi-quantitative measurement of functional capacity on a scale from 1 to 4:
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. | 1 patient who died before the 30-day follow-up could not be assessed | Posted | Mean | Standard Deviation | units on a scale from 1 to 4 | 30 days after baseline |
|
|
|
| Other Pre-specified | All-cause Mortality | The study was terminated after every participant reached the 30-day follow-up point because of slow recruitment and a lack of funding to complete further follow-up | Posted | 6 months after baseline |
|
|
| Other Pre-specified | 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. | Not Posted | 6 months after baseline | Participants |
| Other Pre-specified | 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. | Not Posted | 6 months after baseline | Participants |
| Other Pre-specified | Weight Change | Weight change [kg] 7 days after baseline compared to baseline weight. | Not Posted | 7 days after baseline | Participants |
| Other Pre-specified | Self-reported Orthopnea | The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea. | Not Posted | 30 days after baseline | Participants |
| Other Pre-specified | 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. | Not Posted | 30 days after baseline | Participants |
| Other Pre-specified | NYHA Functional Class | The patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator. | Not Posted | 30 days after baseline | Participants |
| 1 |
| 50 |
| 1 |
| 50 |
| 0 |
| 50 |
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