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

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ClinicalTrials.gov Identifier: NCT05411991

Recruitment Status : Recruiting

First Posted : June 9, 2022

Last Update Posted : June 15, 2022

See Contacts and Locations

Sponsor:

Collaborators:

Roche Diagnostics

Jessa Hospital

Information provided by (Responsible Party):

Frederik Hendrik Verbrugge, MD PhD, Vrije Universiteit Brussel

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.

Condition or disease	Intervention/treatment	Phase
Acute Heart Failure Diuretics Drug Reactions	Diagnostic Test: UNa measurement after intravenous loop diuretic bolus Drug: Intravenous acetazolamide 500 mg OD Drug: Intravenous bumetanide TID Drug: Oral chlorthalidone OD Drug: Intravenous canrenoate 200 mg OD Other: Maintenance infusion Drug: Oral potassium supplements Other: Intravenous hypertonic saline Other: Switch to oral diuretic therapy Other: Usual AHF care	Phase 4

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	104 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
Actual Study Start Date :	June 12, 2022
Estimated Primary Completion Date :	July 31, 2023
Estimated Study Completion Date :	July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Rashes Urine and Urination

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention arm 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	Diagnostic Test: UNa measurement after intravenous loop diuretic bolus Sodium concentration is measured on a urine spot sample, collected 30-120 min after administration of every protocol-specified intravenous bumetanide dose. Drug: Intravenous acetazolamide 500 mg OD 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. Other Name: Diamox (brand name for acetazolamide) Drug: Intravenous bumetanide TID 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. Other Name: Burinex (brand name for bumetanide) Drug: Oral chlorthalidone OD 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. Other Name: Hygroton (brand name for chlorthalidone) Drug: Intravenous canrenoate 200 mg OD 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. Other Name: Soldactone (brand name for canrenoate) Other: Maintenance infusion 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%). Drug: Oral potassium supplements 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 Other Name: KCl Other: Intravenous hypertonic saline 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. Other: Switch to oral diuretic therapy 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
Active Comparator: Control arm 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.	Other: Usual AHF care 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.

Arm

Intervention/treatment

Experimental: Intervention arm

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

Diagnostic Test: UNa measurement after intravenous loop diuretic bolus

Sodium concentration is measured on a urine spot sample, collected 30-120 min after administration of every protocol-specified intravenous bumetanide dose.

Drug: Intravenous acetazolamide 500 mg OD

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.

Other Name: Diamox (brand name for acetazolamide)

Drug: Intravenous bumetanide TID

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.

Other Name: Burinex (brand name for bumetanide)

Drug: Oral chlorthalidone OD

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.

Other Name: Hygroton (brand name for chlorthalidone)

Drug: Intravenous canrenoate 200 mg OD

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.

Other Name: Soldactone (brand name for canrenoate)

Other: Maintenance infusion

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%).

Drug: Oral potassium supplements

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

Other Name: KCl

Other: Intravenous hypertonic saline

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.

Other: Switch to oral diuretic therapy

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

Active Comparator: Control arm

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.

Other: Usual AHF care

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.

Outcome Measures

Primary Outcome Measures :

Mortality, days in hospital & decongestion [ Time Frame: 30 days ]
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 [ Time Frame: 30 days ]
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 [ Time Frame: 30 days ]
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 [ Time Frame: 30 days ]
Relative NT-proBNP change from baseline to 30 days after randomisation [%].
Cancer antigen 125 (CA125) change after 30 days [ Time Frame: 30 days ]
Relative cancer antigen 125 (CA125) change from baseline to 30 days after randomisation [%].
Number of participants with successful clinical decongestion [ Time Frame: 30 days ]
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 [ Time Frame: 30 days ]
Number of consecutive days from randomization during the index admission on which intravenous diuretic therapy was administered.
Overall well-being after decongestion [ Time Frame: 30 days ]
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 [ Time Frame: 30 days ]
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 [ Time Frame: 30 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 [ Time Frame: 30 days ]
Number of participants who are death or have a non-elective hospital admission

Other Outcome Measures:

Overall well-being at discharge [ Time Frame: 30 days ]
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).
Overall well-being after 30 days [ Time Frame: 30 days ]
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).
Edema score after decongestion [ Time Frame: 30 days ]
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.
Edema score at discharge [ Time Frame: 30 days ]
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.
Edema score after 30 days [ Time Frame: 30 days ]
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.
Weight change with decongestion [ Time Frame: 30 days ]
Weight change [kg] from baseline to the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Natriuretic peptide change after decongestion [ Time Frame: 30 days ]
Relative NT-proBNP change from baseline to the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol [%].
Cancer antigen 125 (CA125) change after decongestion [ Time Frame: 30 days ]
Relative cancer antigen 125 (CA125) change from baseline to the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol [%].
Change in eGFR after 30 days (serum creatinine-based) [ Time Frame: 30 days ]
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.
Change in eGFR after 30 days (plasma cystatin C-based) [ Time Frame: 30 days ]
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.
Change in eGFR after 30 days (serum creatinine/plasma cystatin C-based) [ Time Frame: 30 days ]
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.
Hyperkalemia [ Time Frame: 30 days ]
Hyperkalemia with serum potassium levels >5.5 mmol/L at any time during the study period.
Severe hyperkalemia [ Time Frame: 30 days ]
Severe hyperkalemia with serum potassium levels >6.5 mmol/L at any time during the study period.
Hypokalemia [ Time Frame: 30 days ]
Hypokalemia with serum potassium levels <3.5 mmol/L at any time during the study period.
Hyponatremia [ Time Frame: 30 days ]
Hyponatremia with serum sodium levels <135 mmol/L at any time during the study period.
Severe hyponatremia [ Time Frame: 30 days ]
Severe hyponatremia with serum sodium levels <125 mmol/L at any time during the study period.
Hypernatremia [ Time Frame: 30 days ]
Hypernatremia with serum sodium levels >145 mmol/L at any time during the study period.
Severe metabolic acidosis [ Time Frame: 30 days ]
Severe metabolic acidosis with serum bicarbonate levels <20 mmol/L at any time during the study period.
E/e' after decongestion [ Time Frame: 30 days ]
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.
E/e' at discharge [ Time Frame: 30 days ]
Averaged medial/lateral E/e' ratio on transthoracic echocardiography upon the moment of hospital discharge for the index hospitalisation.
E/e' after 30 days [ Time Frame: 30 days ]
Averaged medial/lateral E/e' ratio on transthoracic echocardiography 30 days after randomisation.
Peak left atrial longitudinal strain after decongestion [ Time Frame: 30 days ]
Peak left atrial longitudinal strain on transthoracic echocardiography upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Peak left atrial longitudinal strain at discharge [ Time Frame: 30 days ]
Peak left atrial longitudinal strain on transthoracic echocardiography upon the moment of hospital discharge for the index hospitalisation.
Peak left atrial longitudinal strain after 30 days [ Time Frame: 30 days ]
Peak left atrial longitudinal strain on transthoracic echocardiography 30 days after randomisation.
Tricuspid plane annular excursion over right ventricular systolic pressure (TAPSE/RVSP) ratio after decongestion [ Time Frame: 30 days ]
TAPSE/RVSP ratio on transthoracic echocardiography upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
TAPSE/RVSP ratio at discharge [ Time Frame: 30 days ]
TAPSE/RVSP ratio on transthoracic echocardiography upon the moment of hospital discharge for the index hospitalisation.
TAPSE/RVSP ratio after 30 days [ Time Frame: 30 days ]
TAPSE/RVSP ratio on transthoracic echocardiography 30 days after randomisation.
B-lines after decongestion [ Time Frame: 30 days ]
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.
B-lines at discharge [ Time Frame: 30 days ]
Number of B-lines on lung ultrasound, scanning 8 thoracic sites upon the moment of hospital discharge for the index hospitalisation.
B-lines after 30 days [ Time Frame: 30 days ]
Number of B-lines on lung ultrasound, scanning 8 thoracic sites 30 days after randomisation.
VExUS score after decongestion [ Time Frame: 30 days ]
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
VExUS score at discharge [ Time Frame: 30 days ]
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
VExUS score after 30 days [ Time Frame: 30 days ]
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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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:
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05411991

Contacts

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Contact: Simon Vanhentenrijk, M.D.; Pharm.D.	+32 2 474 9060	simon.vanhentenrijk@uzbrussel.be
Contact: Theodoros Kalpakos, M.D.	+32 2 474 9060	theodoros.kalpakos@uzbrussel.be

Locations

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Belgium
University Hospital Brussels	Recruiting
Jette, Brussels, Belgium, 1090
Contact: Simon Vanhentenrijk, M.D.; Pharm.D. +32 2 474 9060 simon.vanhentenrijk@uzbrussel.be
Contact: Theodoros Kalpakos, M.D. +32 2 474 9060 theodoros.kalpakos@uzbrussel.be
Sub-Investigator: Stijn Lochy, M.D.
Sub-Investigator: Tim Balthazar, M.D.
Sub-Investigator: Berlinde Von Kemp, M.D.
Sub-Investigator: Caroline Weytjens, M.D.; Ph.D.
Sub-Investigator: Steven Droogmans, M.D.; Ph.D.
Sub-Investigator: Danielle Plein, M.D.
Sub-Investigator: Simon Vanhentenrijk, M.D.; Pharm.D.
Sub-Investigator: Theodoros Kalpakos, M.D.
Principal Investigator: Frederik H Verbrugge, M.D.; Ph.D.
Sub-Investigator: Bram Roosens, M.D.; Ph.D.
Jessa Hospital	Not yet recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Jan Verwerft, M.D. +32 11 87 11 87 jan.verwerft@jessazh.be
Principal Investigator: Jan Verwerft, M.D.

Sponsors and Collaborators

Vrije Universiteit Brussel

Roche Diagnostics

Jessa Hospital

Investigators

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Principal Investigator:	Frederik H Verbrugge, M.D.; Ph.D.	Vrije Universiteit Brussel

Study Documents (Full-Text)

Documents provided by Frederik Hendrik Verbrugge, MD PhD, Vrije Universiteit Brussel:

Study Protocol [PDF] February 28, 2022

More Information

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Responsible Party:	Frederik Hendrik Verbrugge, MD PhD, Head of Clinic/Clinical Professor, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:	NCT05411991
Other Study ID Numbers:	EC-2021-236 2021-005426-18 ( EudraCT Number )
First Posted:	June 9, 2022 Key Record Dates
Last Update Posted:	June 15, 2022
Last Verified:	June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
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.
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP)
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.

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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

Keywords provided by Frederik Hendrik Verbrugge, MD PhD, Vrije Universiteit Brussel:


Acute Heart Failure Natriuresis Diuretics Edema

Additional relevant MeSH terms:

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Heart Failure Drug-Related Side Effects and Adverse Reactions Heart Diseases Cardiovascular Diseases Chemically-Induced Disorders Chlorthalidone Acetazolamide Bumetanide Diuretics Sodium Potassium Chloride Symporter Inhibitors	Natriuretic Agents Physiological Effects of Drugs Anticonvulsants Carbonic Anhydrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Sodium Chloride Symporter Inhibitors Membrane Transport Modulators

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