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Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment (DECONGEST)

Primary Purpose

Acute Heart Failure, Diuretics Drug Reactions

Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
UNa measurement after intravenous loop diuretic bolus
Intravenous acetazolamide 500 mg OD
Intravenous bumetanide TID
Oral chlorthalidone OD
Intravenous canrenoate 200 mg OD
Maintenance infusion
Oral potassium supplements
Intravenous hypertonic saline
Switch to oral diuretic therapy
Usual AHF care
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Acute Heart Failure, Natriuresis, Diuretics, Edema

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • At least 18 y/o and able to provide informed consent
  • Hospital admission (anticipated stay >24 h after randomisation) with diagnosis of acute heart failure according to the treating physician

  • At least one of the following three signs of volume overload:

    1. bilateral oedema 2+, indicating clear pitting
    2. ascites that is amenable for drainage, confirmed by echography (no obligation to perform abdominal echocardiography, but necessary when presence of ascites is used as an entry criterion for the study)
    3. uni- or bilateral pleural effusions that are amenable for drainage, confirmed by chest X-ray or lung ultrasound (no obligation to perform chest X-ray, but necessary when presence of pleural effusions is used as an entry criterion for the study)
  • Plasma NTproBNP level >1,000 ng/L

Exclusion criteria:

  • No possibility to collect reliable urine spot samples after diuretic administration
  • Administration of any diuretic within 6 h before randomisation, except for a mineralocorticoid receptor antagonist or sodium glucose co-transporter-2 inhibitor as part of the patient's maintenance treatment for heart failure. Patients can still be included after withholding these diuretics for 6 h, after which randomisation can be performed if they qualify all other criteria.
  • Severe kidney dysfunction, defined as an eGFR <15 mL/min/1.73m² calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and/or previous, current, or planned future renal replacement therapy
  • Systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg, or need for inotropes/vasopressor therapy at randomisation
  • Any acute coronary syndrome within 30 days prior to enrolment, defined as typical chest pain with a troponin rise above the 99th percentile of normal and/or electrocardiographic changes suggestive of cardiac ischemia
  • History of heart or kidney transplantation
  • History of mechanical circulatory support
  • Known obstructive hypertrophic cardiomyopathy, congenital heart disease, acute mechanical cause of acute heart failure (e.g., papillary muscular rupture), acute myocarditis, or constrictive pericarditis according to the treating physician
  • Pregnant or breastfeeding woman
  • Concomitant participation in another interventional study

Sites / Locations

  • University Hospital BrusselsRecruiting
  • Jessa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Control arm

Arm Description

Application of a standardized diuretic schedule with following key components: UNa assessment in spot urine sample after every bolus of loop diuretics with continuation of intravenous diuretics until absence of clinical signs of fluid overload AND UNa <80 mmol/L Loop diuretic dosing according to estimated glomerular filtration rate (eGFR) with higher dose for lower eGFR Upfront use of intravenous acetazolamide 500 mg OD unless hypernatremia or metabolic acidosis Upfront use of oral chlorthalidone 50 mg OD if eGFR <30 mL/min/1.73m² OR hypernatremia Full nephron blockade with intravenous acetazolamide 500 mg OD, intravenous bumetanide 4 mg TID, oral chlorthalidone 100 mg OD, and intravenous canrenoate 200 mg OD in case of diuretic resistance, defined as UNa <80 mmol/L and persistent clinical signs of fluid overload Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics

Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.

Outcomes

Primary Outcome Measures

Mortality, days in hospital & decongestion
Win ratio for a hierarchically composed endpoint of mortality, days in hospital and relative decrease in N-terminal pro-hormone of B-type natriuretic peptide (NT-proBNP) levels after 30 days.

Secondary Outcome Measures

Renal safety endpoint
Doubling of the serum creatinine or plasma cystatin C value compared to baseline with an absolute value >2 mg/dL or >2 mg/L, respectively, or the need for ultrafiltration and/or renal replacement therapy during the index hospital admission.
Hemodynamic safety endpoint
Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg or need for vasopressors and/or inotropes during the index hospital admission.
Natriuretic peptide change after 30 days
Relative NT-proBNP change from baseline to 30 days after randomisation [%].
Cancer antigen 125 (CA125) change after 30 days
Relative cancer antigen 125 (CA125) change from baseline to 30 days after randomisation [%].
Number of participants with successful clinical decongestion
Number of participants with no more than trace edema, absence of jugular venous distension and no rales upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Length of intravenous diuretic therapy
Number of consecutive days from randomization during the index admission on which intravenous diuretic therapy was administered.
Overall well-being after decongestion
Five-point Likert scale for overall well-being upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol and compared with the moment of randomisation (5: much improved/4: slightly improved/3: neutral/2: slightly worse/1: much worse).
Length of the index hospital admission
Length of the index hospital admission [days].
Number of participants who are death, or have a non-elective hospital admission or non-elective medical contact
Number of participants who are death, or have a non-elective hospital admission or non-elective medical contact
Number of participants who are death or have a non-elective hospital admission
Number of participants who are death or have a non-elective hospital admission

Full Information

First Posted
June 6, 2022
Last Updated
September 17, 2023
Sponsor
Vrije Universiteit Brussel
Collaborators
Roche Diagnostics, Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05411991
Brief Title
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
Acronym
DECONGEST
Official Title
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
Collaborators
Roche Diagnostics, Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pragmatic, multicenter, interventional, parallel-arm, randomized, open-label trial to investigate whether a diuretic regimen, based on serial assessment of sodium concentration (UNa) on spot urine samples after diuretic administration and with low-threshold use of combination diuretic therapy, improves decongestion versus usual care in acute heart failure (AHF), potentially leading to better clinical outcomes.
Detailed Description
Key interventions are: Assessment of UNa in spot urine samples after every bolus administration of loop diuretics with continuation of intravenous diuretics until resolution of clinical signs of fluid overload AND UNa <80 mmol/L Dosing of loop diuretic bolus according to estimated glomerular filtration rate (eGFR) Upfront use of intravenous acetazolamide 500 mg OD unless hypernatremia (>145 mmol/L) or metabolic acidosis (bicarbonate <22 mmol/L) Upfront use of oral chlorthalidone 50 mg OD if eGFR <30 mL/min/1.73m² OR hypernatremia (>145 mmol/L) Switch to full nephron blockade with intravenous acetazolamide 500 mg OD, intravenous bumetanide 4 mg TID, oral chlorthalidone 100 mg OD, and intravenous canrenoate 200 mg OD in case of diuretic resistance, defined as UNa <80 mmol/L and persistent clinical signs of fluid overload Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during diuretic therapy with intravenous diuretics

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure, Diuretics Drug Reactions
Keywords
Acute Heart Failure, Natriuresis, Diuretics, Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Application of a standardized diuretic schedule with following key components: UNa assessment in spot urine sample after every bolus of loop diuretics with continuation of intravenous diuretics until absence of clinical signs of fluid overload AND UNa <80 mmol/L Loop diuretic dosing according to estimated glomerular filtration rate (eGFR) with higher dose for lower eGFR Upfront use of intravenous acetazolamide 500 mg OD unless hypernatremia or metabolic acidosis Upfront use of oral chlorthalidone 50 mg OD if eGFR <30 mL/min/1.73m² OR hypernatremia Full nephron blockade with intravenous acetazolamide 500 mg OD, intravenous bumetanide 4 mg TID, oral chlorthalidone 100 mg OD, and intravenous canrenoate 200 mg OD in case of diuretic resistance, defined as UNa <80 mmol/L and persistent clinical signs of fluid overload Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Intervention Type
Diagnostic Test
Intervention Name(s)
UNa measurement after intravenous loop diuretic bolus
Intervention Description
Sodium concentration is measured on a urine spot sample, collected 30-120 min after administration of every protocol-specified intravenous bumetanide dose.
Intervention Type
Drug
Intervention Name(s)
Intravenous acetazolamide 500 mg OD
Other Intervention Name(s)
Diamox (brand name for acetazolamide)
Intervention Description
Upfront use of intravenous acetazolamide 500 mg OD as part of the diuretic treatment, unless hypernatremia (>145 mmol/L) or metabolic acidosis (bicarbonate <22 mmol/L) is present at the moment of the scheduled administration.
Intervention Type
Drug
Intervention Name(s)
Intravenous bumetanide TID
Other Intervention Name(s)
Burinex (brand name for bumetanide)
Intervention Description
An intravenous bolus of bumetanide is administered TID, with dosing according to eGFR: 2 mg for an eGFR >45 mL/min/1.73m²; 3 mg for an eGFR 30-45 mL/min/1.73m²; and 4 mg for an eGFR <30 mL/min/1.73m². At any time diuretic resistance is encountered (persistent clinical signs of fluid overload with UNa <80 mmol/L), a dose of 4 mg TID is used.
Intervention Type
Drug
Intervention Name(s)
Oral chlorthalidone OD
Other Intervention Name(s)
Hygroton (brand name for chlorthalidone)
Intervention Description
In case of hypernatremia (>145 mmol/L) or low eGFR (<30 mL/min/1.73m²), oral chlorthalidone 50 mg OD is added to the diuretic treatment. At any time diuretic resistance is encountered (persistent clinical signs of fluid overload with UNa <80 mmol/L), oral chlorthalidone is provided at a dose of 100 mg OD. Chlorthalidone is never administered in case of hypotonic hyponatremia with serum sodium concentration <135 mmol/L.
Intervention Type
Drug
Intervention Name(s)
Intravenous canrenoate 200 mg OD
Other Intervention Name(s)
Soldactone (brand name for canrenoate)
Intervention Description
At any time diuretic resistance is encountered (persistent clinical signs of fluid overload with UNa <80 mmol/L), intravenous canrenoate 200 mg OD is provided. Canrenoate is never administered in case of hypotonic hyponatremia with serum sodium concentration <135 mmol/L or if serum potassium levels are >5.5 mmol/L. If canrenoate is administered, oral mineralocorticoid receptor drugs are temporarily withhold until switch to oral diuretic treatment.
Intervention Type
Other
Intervention Name(s)
Maintenance infusion
Intervention Description
A maintenance infusion with 500 mL dextrose 5% and 3 g MgSO4 is started at an infusion rate of 20 mL/h upon the moment of first protocol-specified administration of intravenous diuretics and continued until switch to oral diuretic therapy. 40 mmol KCl is added if serum potassium levels are <4 mmol/L. In case of hypotonic hyponatremia with serum sodium concentration <130 mmol/L, dextrose 5% will not be provided and MgSO4 will be administered in 50 mL of normal saline (NaCl 0.9%).
Intervention Type
Drug
Intervention Name(s)
Oral potassium supplements
Other Intervention Name(s)
KCl
Intervention Description
If serum potassium levels are <3.5 mmol/L at any time during the administration of intravenous diuretics, oral potassium supplements are provided as needed to keep serum potassium levels >4 mmol/L
Intervention Type
Other
Intervention Name(s)
Intravenous hypertonic saline
Intervention Description
In case of hypotonic hyponatremia with serum sodium concentration <125 mmol/L, a bolus of 150 mL hypertonic saline 3% is administered and repeated OD if necessary, until sodium levels are ≥135 mmol/L.
Intervention Type
Other
Intervention Name(s)
Switch to oral diuretic therapy
Intervention Description
Upon complete resolution of clinical signs of fluid overload with UNa <80 mmol/L, intravenous diuretics are switched to an oral schedule including: Loop diuretics with dose & frequency at the discretion of the treating physician Chlorthalidone 50 mg if added for diuretic resistance at any time during the intravenous diuretic phase Spironolactone 25 mg or another equivalent mineralocorticoid receptor antagonist
Intervention Type
Other
Intervention Name(s)
Usual AHF care
Intervention Description
It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
Primary Outcome Measure Information:
Title
Mortality, days in hospital & decongestion
Description
Win ratio for a hierarchically composed endpoint of mortality, days in hospital and relative decrease in N-terminal pro-hormone of B-type natriuretic peptide (NT-proBNP) levels after 30 days.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Renal safety endpoint
Description
Doubling of the serum creatinine or plasma cystatin C value compared to baseline with an absolute value >2 mg/dL or >2 mg/L, respectively, or the need for ultrafiltration and/or renal replacement therapy during the index hospital admission.
Time Frame
30 days
Title
Hemodynamic safety endpoint
Description
Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg or need for vasopressors and/or inotropes during the index hospital admission.
Time Frame
30 days
Title
Natriuretic peptide change after 30 days
Description
Relative NT-proBNP change from baseline to 30 days after randomisation [%].
Time Frame
30 days
Title
Cancer antigen 125 (CA125) change after 30 days
Description
Relative cancer antigen 125 (CA125) change from baseline to 30 days after randomisation [%].
Time Frame
30 days
Title
Number of participants with successful clinical decongestion
Description
Number of participants with no more than trace edema, absence of jugular venous distension and no rales upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Time Frame
30 days
Title
Length of intravenous diuretic therapy
Description
Number of consecutive days from randomization during the index admission on which intravenous diuretic therapy was administered.
Time Frame
30 days
Title
Overall well-being after decongestion
Description
Five-point Likert scale for overall well-being upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol and compared with the moment of randomisation (5: much improved/4: slightly improved/3: neutral/2: slightly worse/1: much worse).
Time Frame
30 days
Title
Length of the index hospital admission
Description
Length of the index hospital admission [days].
Time Frame
30 days
Title
Number of participants who are death, or have a non-elective hospital admission or non-elective medical contact
Description
Number of participants who are death, or have a non-elective hospital admission or non-elective medical contact
Time Frame
30 days
Title
Number of participants who are death or have a non-elective hospital admission
Description
Number of participants who are death or have a non-elective hospital admission
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Overall well-being at discharge
Description
Five point Likert scale for overall well-being upon the moment of hospital discharge for the index hospitalisation and compared with the moment of randomisation (5: much improved/4: slightly improved/3: neutral/2: slightly worse/1: much worse).
Time Frame
30 days
Title
Overall well-being after 30 days
Description
Five point Likert scale for overall well-being 30 days after randomisation and compared with the moment of randomisation (5: much improved/4: slightly improved/3: neutral/2: slightly worse/1: much worse).
Time Frame
30 days
Title
Edema score after decongestion
Description
Edema score (1+: trace; 2+ clear pitting; 3+ clear pitting with visual deformation below the knee; 4+: clear pitting with visual deformation above the knee) upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Time Frame
30 days
Title
Edema score at discharge
Description
Edema score (1+: trace; 2+ clear pitting; 3+ clear pitting with visual deformation below the knee; 4+: clear pitting with visual deformation above the knee) upon the moment of hospital discharge for the index hospitalisation.
Time Frame
30 days
Title
Edema score after 30 days
Description
Edema score (1+: trace; 2+ clear pitting; 3+ clear pitting with visual deformation below the knee; 4+: clear pitting with visual deformation above the knee) 30 days after randomisation.
Time Frame
30 days
Title
Weight change with decongestion
Description
Weight change [kg] from baseline to the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Time Frame
30 days
Title
Natriuretic peptide change after decongestion
Description
Relative NT-proBNP change from baseline to the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol [%].
Time Frame
30 days
Title
Cancer antigen 125 (CA125) change after decongestion
Description
Relative cancer antigen 125 (CA125) change from baseline to the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol [%].
Time Frame
30 days
Title
Change in eGFR after 30 days (serum creatinine-based)
Description
Change in eGFR from randomisation towards 30 days [mL/min/1.73m²] with eGFR calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula with serum creatinine.
Time Frame
30 days
Title
Change in eGFR after 30 days (plasma cystatin C-based)
Description
Change in eGFR from randomisation towards 30 days [mL/min/1.73m²] with eGFR calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula with plasma cystatin C.
Time Frame
30 days
Title
Change in eGFR after 30 days (serum creatinine/plasma cystatin C-based)
Description
Change in eGFR from randomisation towards 30 days [mL/min/1.73m²] with eGFR calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula with serum creatinine and plasma cystatin C.
Time Frame
30 days
Title
Hyperkalemia
Description
Hyperkalemia with serum potassium levels >5.5 mmol/L at any time during the study period.
Time Frame
30 days
Title
Severe hyperkalemia
Description
Severe hyperkalemia with serum potassium levels >6.5 mmol/L at any time during the study period.
Time Frame
30 days
Title
Hypokalemia
Description
Hypokalemia with serum potassium levels <3.5 mmol/L at any time during the study period.
Time Frame
30 days
Title
Hyponatremia
Description
Hyponatremia with serum sodium levels <135 mmol/L at any time during the study period.
Time Frame
30 days
Title
Severe hyponatremia
Description
Severe hyponatremia with serum sodium levels <125 mmol/L at any time during the study period.
Time Frame
30 days
Title
Hypernatremia
Description
Hypernatremia with serum sodium levels >145 mmol/L at any time during the study period.
Time Frame
30 days
Title
Severe metabolic acidosis
Description
Severe metabolic acidosis with serum bicarbonate levels <20 mmol/L at any time during the study period.
Time Frame
30 days
Title
E/e' after decongestion
Description
Averaged medial/lateral E/e' ratio on transthoracic echocardiography upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Time Frame
30 days
Title
E/e' at discharge
Description
Averaged medial/lateral E/e' ratio on transthoracic echocardiography upon the moment of hospital discharge for the index hospitalisation.
Time Frame
30 days
Title
E/e' after 30 days
Description
Averaged medial/lateral E/e' ratio on transthoracic echocardiography 30 days after randomisation.
Time Frame
30 days
Title
Peak left atrial longitudinal strain after decongestion
Description
Peak left atrial longitudinal strain on transthoracic echocardiography upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Time Frame
30 days
Title
Peak left atrial longitudinal strain at discharge
Description
Peak left atrial longitudinal strain on transthoracic echocardiography upon the moment of hospital discharge for the index hospitalisation.
Time Frame
30 days
Title
Peak left atrial longitudinal strain after 30 days
Description
Peak left atrial longitudinal strain on transthoracic echocardiography 30 days after randomisation.
Time Frame
30 days
Title
Tricuspid plane annular excursion over right ventricular systolic pressure (TAPSE/RVSP) ratio after decongestion
Description
TAPSE/RVSP ratio on transthoracic echocardiography upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Time Frame
30 days
Title
TAPSE/RVSP ratio at discharge
Description
TAPSE/RVSP ratio on transthoracic echocardiography upon the moment of hospital discharge for the index hospitalisation.
Time Frame
30 days
Title
TAPSE/RVSP ratio after 30 days
Description
TAPSE/RVSP ratio on transthoracic echocardiography 30 days after randomisation.
Time Frame
30 days
Title
B-lines after decongestion
Description
Number of B-lines on lung ultrasound, scanning 8 thoracic sites upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Time Frame
30 days
Title
B-lines at discharge
Description
Number of B-lines on lung ultrasound, scanning 8 thoracic sites upon the moment of hospital discharge for the index hospitalisation.
Time Frame
30 days
Title
B-lines after 30 days
Description
Number of B-lines on lung ultrasound, scanning 8 thoracic sites 30 days after randomisation.
Time Frame
30 days
Title
VExUS score after decongestion
Description
VExUS score for venous Doppler measurements (0: inferior vena cava diameter <2 cm; 1: inferior vena cava diameter ≥2 cm and normal Doppler measurements; 2: inferior vena cava diameter ≥2 cm and at least 1 severely abnormal* Doppler pattern in the Vv. hepaticae, V. portae or Vv. intrarenalis; 3: inferior vena cava diameter ≥2 cm and at least 2 severely abnormal* Doppler patterns in the Vv. hepaticae, V. portae or Vv. intrarenalis) upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol. *The following Doppler patterns are considered severely abnormal: Vv. Hepaticae: systolic flow reversal V. Portae: >50% pulsatility Vv. Intrarenalis: monophasic diastolic flow
Time Frame
30 days
Title
VExUS score at discharge
Description
VExUS score for venous Doppler measurements (0: inferior vena cava diameter <2 cm; 1: inferior vena cava diameter ≥2 cm and normal Doppler measurements; 2: inferior vena cava diameter ≥2 cm and at least 1 severely abnormal Doppler pattern in the Vv. hepaticae, V. portae or Vv. intrarenalis; 3: inferior vena cava diameter ≥2 cm and at least 2 severely abnormal Doppler patterns in the Vv. hepaticae, V. portae or Vv. intrarenalis) upon the moment of hospital discharge for the index hospitalisation. *The following Doppler patterns are considered severely abnormal: Vv. Hepaticae: systolic flow reversal V. Portae: >50% pulsatility Vv. Intrarenalis: monophasic diastolic flow
Time Frame
30 days
Title
VExUS score after 30 days
Description
VExUS score for venous Doppler measurements (0: inferior vena cava diameter <2 cm; 1: inferior vena cava diameter ≥2 cm and normal Doppler measurements; 2: inferior vena cava diameter ≥2 cm and at least 1 severely abnormal Doppler pattern in the Vv. hepaticae, V. portae or Vv. intrarenalis; 3: inferior vena cava diameter ≥2 cm and at least 2 severely abnormal Doppler patterns in the Vv. hepaticae, V. portae or Vv. intrarenalis) 30 days after randomisation. *The following Doppler patterns are considered severely abnormal: Vv. Hepaticae: systolic flow reversal V. Portae: >50% pulsatility Vv. Intrarenalis: monophasic diastolic flow
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: At least 18 y/o and able to provide informed consent Hospital admission (anticipated stay >24 h after randomisation) with diagnosis of acute heart failure according to the treating physician At least one of the following three signs of volume overload: bilateral oedema 2+, indicating clear pitting ascites that is amenable for drainage, confirmed by echography (no obligation to perform abdominal echocardiography, but necessary when presence of ascites is used as an entry criterion for the study) uni- or bilateral pleural effusions that are amenable for drainage, confirmed by chest X-ray or lung ultrasound (no obligation to perform chest X-ray, but necessary when presence of pleural effusions is used as an entry criterion for the study) Plasma NTproBNP level >1,000 ng/L Exclusion criteria: No possibility to collect reliable urine spot samples after diuretic administration Administration of any diuretic within 6 h before randomisation, except for a mineralocorticoid receptor antagonist or sodium glucose co-transporter-2 inhibitor as part of the patient's maintenance treatment for heart failure. Patients can still be included after withholding these diuretics for 6 h, after which randomisation can be performed if they qualify all other criteria. Severe kidney dysfunction, defined as an eGFR <15 mL/min/1.73m² calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and/or previous, current, or planned future renal replacement therapy Systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg, or need for inotropes/vasopressor therapy at randomisation Any acute coronary syndrome within 30 days prior to enrolment, defined as typical chest pain with a troponin rise above the 99th percentile of normal and/or electrocardiographic changes suggestive of cardiac ischemia History of heart or kidney transplantation History of mechanical circulatory support Known obstructive hypertrophic cardiomyopathy, congenital heart disease, acute mechanical cause of acute heart failure (e.g., papillary muscular rupture), acute myocarditis, or constrictive pericarditis according to the treating physician Pregnant or breastfeeding woman Concomitant participation in another interventional study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Vanhentenrijk, M.D.; Pharm.D.
Phone
+32 2 474 9060
Email
simon.vanhentenrijk@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Theodoros Kalpakos, M.D.
Phone
+32 2 474 9060
Email
theodoros.kalpakos@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik H Verbrugge, M.D.; Ph.D.
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Brussels
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Vanhentenrijk, M.D.; Pharm.D.
Phone
+32 2 474 9060
Email
simon.vanhentenrijk@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Theodoros Kalpakos, M.D.
Phone
+32 2 474 9060
Email
theodoros.kalpakos@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Caroline Weytjens, M.D.; Ph.D.
First Name & Middle Initial & Last Name & Degree
Steven Droogmans, M.D.; Ph.D.
First Name & Middle Initial & Last Name & Degree
Danielle Plein, M.D.
First Name & Middle Initial & Last Name & Degree
Simon Vanhentenrijk, M.D.; Pharm.D.
First Name & Middle Initial & Last Name & Degree
Theodoros Kalpakos, M.D.
First Name & Middle Initial & Last Name & Degree
Frederik H Verbrugge, M.D.; Ph.D.
First Name & Middle Initial & Last Name & Degree
Bram Roosens, M.D.; Ph.D.
First Name & Middle Initial & Last Name & Degree
Laura Braeckeveldt, M.D.
First Name & Middle Initial & Last Name & Degree
Eleftherios Choustoulakis, M.D.; M.Sc.
Facility Name
Jessa Hospital
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Verwerft, M.D.
Phone
+32 11 87 11 87
Email
jan.verwerft@jessazh.be
First Name & Middle Initial & Last Name & Degree
Jan Verwerft, M.D.
First Name & Middle Initial & Last Name & Degree
Simon Vanhentenrijk, M.D.; Pharm.D.
First Name & Middle Initial & Last Name & Degree
Vincent Vandoren, M.D.
First Name & Middle Initial & Last Name & Degree
Wouter L'Hoyes, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be made available upon reasonable request in adherence with transparency conventions in medical research and through requests to the chief investigator (Frederik H. Verbrugge, frederik.verbrugge@uzbrussel.be). The executive committee of DECONGEST has developed a comprehensive analysis plan and numerous prespecified analyses, which will be presented in future scientific presentations and publications. At a later time point, the full database will be made available in adherence with the ratified transparency policy.
IPD Sharing Time Frame
The study protocol will be shared through clinicaltrials.gov immediately upon release. The statistical analysis plan will be shared before database lock at the end of the study.

Learn more about this trial

Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment

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