Acute Heart Failure (AHF)Phase 2/3POINTER-HFNCT07469722
POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure
A Phase 2/3 study testing Furosemide 40 Milligrams., Hydrochlorothiazide (HCTZ) 25 milligrams. and Acetazolamide 250 milligrams. in people with Acute Heart Failure (AHF) and Congestive Heart Failure Acute, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Acute decompensated heart failure (ADHF) is a frequent cause of hospitalization and is associated with high morbidity and mortality. Congestion is the primary pathophysiological mechanism leading to clinical deterioration and hospitalization in ADHF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Congestive Heart Failure Acute, Diuretic Effect
- What is being tested?
- Furosemide 40 Milligrams., Hydrochlorothiazide (HCTZ) 25 milligrams. and Acetazolamide 250 milligrams.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Mar 2026to 1 Jul 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Men or women aged 18 years or older.
- Diagnosis of acute decompensated heart failure (ADHF) with left ventricular ejection fraction <50%, presenting with symptoms (dyspnea, orthopnea, fatigue) and/or signs (pulmonary crackles, peripheral edema, jugular venous distension, hepatomegaly, hepatojugular reflux) of decompensated heart failure.
- Brain natriuretic peptide (BNP) ≥ 300 pg/mL.
- Signs of systemic and/or pulmonary congestion on POCUS, defined as DUCS ≥ 3 points.
- Time from hospital admission ≤ 48 hours.
- Signed informed consent.
Who cannot join
- Patients under evaluation for heart transplantation or with prior heart transplantation.
- Acute coronary syndrome as the primary cause of hospitalization.
- Evidence of uncontrolled infection.
- Cardiac surgery or percutaneous coronary or structural cardiac intervention within the previous 30 days.
- Signs of hypoperfusion, defined as any of the following: mean arterial pressure < 60 mmHg, capillary refill time > 4 seconds, arterial lactate > 2 mmol/L or venous lactate > 2.5 mmol/L.
- Acute pulmonary embolism (segmental or more proximal) as the primary cause of hospitalization.
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- Acute stroke.
- Chronic kidney disease stage 5 (estimated glomerular filtration rate < 15 ml/min/m²) or requirement for renal replacement therapy.
- Liver cirrhosis with portal hypertension.
- Known pulmonary disease with extensive parenchymal involvement, including interstitial lung disease, pulmonary metastases, prior pneumonectomy, lobectomy, or pleurodesis.
- Severe hypokalemia (serum potassium < 2.5 mmol/L).
- Pregnancy or breastfeeding.
- Refusal to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90410-000
Henrique C Scherer, MD, 5551 33596246, henriquecscherer@gmail.com
About this study
Official title: Point-of-care Ultrasound Intervention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure
Acute decompensated heart failure (ADHF) is a frequent cause of hospitalization and is associated with high morbidity and mortality. Congestion is the primary pathophysiological mechanism leading to clinical deterioration and hospitalization in ADHF. Diuretics remain the cornerstone of treatment for most ADHF phenotypes; however, evidence regarding optimal strategies to guide diuretic therapy during the decongestion process is limited. Recently, point-of-care ultrasound (POCUS) has emerged as a promising tool to support clinical assessment in ADHF, improving diagnostic accuracy, prognostication, and pre-discharge evaluation. Nevertheless, the role of POCUS in guiding therapeutic management in ADHF remains uncertain. To specifically assess congestion in patients with ADHF, a pragmatic POCUS-based score, the Dynamic Ultrasound Congestion Score (DUCS), was developed. DUCS integrates lung ultrasound and Venous Excess Ultrasound (VExUS) to dynamically evaluate congestion severity, treatment response, and therapeutic goals during ADHF management. Observational data suggest that DUCS is associated with in-hospital outcomes and short-term prognosis, and correlates with markers of decongestion such as urinary output and weight loss. This study is a randomized, single-center, single-blind clinical trial designed to evaluate whether a DUCS-guided POCUS strategy improves clinical and decongestion outcomes compared with standard of care. Eligible patients hospitalized due to ADHF will be randomized within 48 hours of admission to one of two groups: (1) diuretic treatment guided by institutional standard-of-care combined with information from the EVEREST congestion score assessment and guideline-based treatment recommendations; or (2) diuretic treatment guided by serial DUCS-based POCUS assessments used to inform diuretic adjustment recommendations. Participants in both groups will undergo evaluations at baseline (day 1), day 2, day 3 and day 5, including clinical data collection, physical examination using the EVEREST congestion score, and standardized DUCS-based POCUS assessments. Outcomes to be assessed include in-hospital mortality, length of hospital stay, decongestion parameters, and changes in biomarkers.
- Conditions
- Acute Heart Failure (AHF), Congestive Heart Failure Acute, Diuretic Effect, Lung Ultrasonography Score, Ultrasonography, Doppler, Point-of-care Ultrasound (POCUS)
- Being tested
- Furosemide 40 Milligrams., Hydrochlorothiazide (HCTZ) 25 milligrams., Acetazolamide 250 milligrams., Dapagliflozin (10mg Tab), Potassium Chloride Oral Product
- Keywords
- Acute Heart Failure, Congestive Heart Failure, Point-of-Care Ultrasound, Lung Ultrasound, Venous Excess Ultrasound, Diuretic
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide 40 Milligrams.Drug
Decongestive therapy with intravenous furosemide, with or without oral hydrochlorothiazide and/or oral acetazolamide, will be adjusted based on DUCS-based POCUS assessments.
Procedure: DUCS-based POCUS protocol DUCS ranges from 0 to 10 points and is divided into three categories: absence of congestion (<2 points), mild to moderate congestion (2-4 points) and severe congestion (≥5 points). DUCS integrates eight-zone lung ultrasound (each zone considered positive in the presence of ≥3 B-lines) and modified VExUS (inferior vena cava, portal vein and hepatic vein Doppler) assessments. For lung ultrasound, 2-3 positive zones score 2 points, 4-5 score 4 points and ≥6 score 5 points. For modified VExUS, grade 1 scores 1 point, grade 2 scores 2 points, and grade 3 scores 5 points. The final DUCS value is calculated as the sum of both components.
Furosemide 40 Milligrams.Drug
Procedure: physical examination according to the EVEREST congestion score and guideline-based treatment recommendations.
Results from the physical examination will be provided to the medical team in the form of the EVEREST composite congestion score (CCS), which ranges from 0 to 9 and incorporates evaluation of jugular venous distension, pedal edema, and orthopnea.
General guideline-based recommendations for the management of ADHF will be provided to the medical team.
Hydrochlorothiazide (HCTZ) 25 milligrams.Drug
Addition of a second diuretic will be recommended, either oral hydrochlorothiazide or oral acetazolamide, according to serum potassium and bicarbonate levels. Hydrochlorothiazide dose will be defined according to serum creatinine and estimated glomerular filtration rate (eGFR).
Acetazolamide 250 milligrams.Drug
Addition of a second diuretic will be recommended, either oral hydrochlorothiazide or oral acetazolamide, according to serum potassium, serum bicarbonate, and estimated glomerular filtration rate (eGFR).
Dapagliflozin (10mg Tab)Drug
Dapagliflozin will be suggested to the treating medical team as part of guideline-directed medical therapy for patients without contraindications.
Potassium Chloride Oral ProductDrug
Oral potassium chloride supplementation will be administered to patients with serum potassium < 4.0 mEq/L in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Standard of care with additional information from the EVEREST congestion score and guideline-based treatment recommendations.
Diuretics will be administered intravenously according to the institutional standard of care, with results from the EVEREST congestion score assessment and guideline-based treatment recommendations provided to the treating medical team. Dapagliflozin will also be suggested as part of guideline-directed medical therapy for patients without contraindications. Receives: Drug: Furosemide 40 Milligrams.; Drug: Dapagliflozin (10mg Tab) |
| Diuretic therapy guided by DUCS-based POCUS | Experimental | Treatment recommendation will be made according to baseline DUCS-based POCUS assessment, as follows:
Patients with DUCS 2-4 points (defined as mild to moderate congestion): the recommended intravenous loop diuretic dose will be twice the patient's previous total daily oral dose. If no diuretics were taken previously, intravenous furosemide 40 mg three times daily will be administered.
Patients with DUCS ≥ 5 points (defined as severe congestion): the recommended intravenous loop diuretic dose will be twice the patient's previous total daily oral dose. If no diuretics were taken previously, intravenous furosemide 40 mg three times daily will be administered. Addition of a second diuretic will be recommended, either oral hydrochlorothiazide or oral acetazolamide, according to serum electrolyte levels.
Serial DUCS-based POCUS assessments will provide recommendations for diuretic therapy adjustments.
Dapagliflozin and oral potassium supplements will also be suggested if appropriate. Receives: Drug: Furosemide 40 Milligrams.; Drug: Hydrochlorothiazide (HCTZ) 25 milligrams.; Drug: Acetazolamide 250 milligrams.; Drug: Dapagliflozin (10mg Tab); Drug: Potassium Chloride Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pairwise Comparisons With Wins of Clinical Benefit, a Composite of In-Hospital Mortality, Hospital Length of Stay, Absence of Congestion on DUCS at Discharge, and BNP Reduction From Admission to Day 7 or Discharge.
Clinical benefit will be assessed using a hierarchical composite endpoint based on pairwise comparisons (win ratio analysis), including the following components, analyzed in a predefined hierarchical order:
- In-hospital mortality: death is worse than no death; earlier death is worse than later death; tied if not possible to determine.
- Hospital length of stay (days): a shorter hospital length of stay is better; a difference of ≥1 day defines a win; tied if the same number of length of stay days.
- Absence of congestion on DUCS at discharge: <2 points at discharge on DUCS is better; tied if both have ≥2 points or if both have <2 points on DUCS.
- BNP reduction at day 7 or discharge (whichever occurs first): a reduction of ≥30% in BNP is better; tied if both achieve or do not achieve a ≥30% reduction.
Measured: From randomization until hospital discharge (assessed up to 90 days).
Secondary outcomes (12)
All-cause in-hospital mortality.
All-cause mortality occurring between hospital admission and discharge will be analyzed to compare the treatment groups.
Measured: From randomization until hospital discharge (assessed up to 90 days).
Hospital length of stay.
Hospital length of stay, measured in days, will be compared between treatment groups.
Measured: From randomization until hospital discharge (assessed up to 90 days).
Proportion of patients without congestion on POCUS at discharge.
Absence of residual congestion at hospital discharge, defined as DUCS <2 points, will be compared between the intervention group and the standard-of-care group.
Measured: From randomization until hospital discharge (assessed up to 90 days).
BNP reduction.
The proportion of patients achieving a ≥30% reduction in BNP from hospital admission to day 7 or hospital discharge (whichever occurs first) will be compared between the intervention and control groups.
Measured: From randomization until hospital discharge (assessed up to 90 days).
Change in body weight.
Change in body weight, measured in kilograms, between hospital admission and discharge will be compared between treatment groups.
Measured: From randomization until hospital discharge (assessed up to 90 days).
Change in dyspnea assessed by the Visual Analogue Scale (VAS).
The area under the curve (AUC) of change in VAS dyspnea score will be compared between treatment groups. Individual scores will be plotted over time, with the x-axis representing study days from baseline to day 5, and the y-axis representing the VAS score (0-100 millimeters). The VAS AUC (millimeter x hour) will be compared between treatment groups.
Measured: Up to day 5.
Proportion of participants with worsening renal function.
Worsening renal function will be defined as an increase of ≥0.3 mg/dL in serum creatinine or a ≥50% increase from baseline within 7 days.
Measured: Up to day 7.
Proportion of patients without congestion on EVEREST at discharge.
The proportion of patients with EVEREST composite congestion score (CCS) ≤ 2 points at hospital discharge will be compared between treatment groups.
Measured: From randomization until hospital discharge (assessed up to 90 days).
In-hospital mortality and major in-hospital clinical events.
A composite outcome including in-hospital mortality, admission to intensive care unit, use of mechanical ventilation, renal replacement therapy, vasopressor use, or inotrope use during the index hospitalization will be assessed and compared between treatment groups.
Measured: From randomization until hospital discharge (assessed up to 90 days).
All-cause mortality or rehospitalization within 30 days.
The proportion of participants who experience all-cause mortality or rehospitalization within 30 days after hospital discharge will be compared between treatment groups.
Measured: From hospital discharge up to 30 days.
All-cause mortality or rehospitalization within 90 days.
The proportion of participants who experience all-cause mortality or rehospitalization within 90 days after hospital discharge will be compared between treatment groups.
Measured: From hospital discharge up to 90 days.
Proportion of participants with electrolyte abnormalities
The proportion of participants with electrolyte abnormalities will be compared between treatment groups, including hypokalemia (serum potassium < 3.0 mEq/L), hyperkalemia (serum potassium > 5.5 mEq/L), hyponatremia (serum sodium < 125 mEq/L), hypernatremia (serum sodium > 150 mEq/L), hypomagnesemia (serum magnesium < 1.2 mg/dL), hypermagnesemia (serum magnesium > 3.0 mg/dL), and metabolic acidosis (serum bicarbonate < 14 mEq/L with arterial pH < 7.15).
Measured: From randomization until hospital discharge (assessed up to 90 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Heart Failure (AHF)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis E Rohde, Professor, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469722
- Sponsor's protocol ID
- 2025-0708
- Acronym
- POINTER-HF
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Metra M, Adamo M, Tomasoni D, Mebazaa A, Bayes-Genis A, Abdelhamid M, Adamopoulos S, Anker SD, Bauersachs J, Belenkov Y, Bohm M, Gal TB, Butler J, Cohen-Solal A, Filippatos G, Gustafsson F, Hill L, Jaarsma T, Jankowska EA, Lainscak M, Lopatin Y, Lund LH, McDonagh T, Milicic D, Moura B, Mullens W, Piepoli M, Polovina M, Ponikowski P, Rakisheva A, Ristic A, Savarese G, Seferovic P, Sharma R, Thum T, Tocchetti CG, Van Linthout S, Vitale C, Von Haehling S, Volterrani M, Coats AJS, Chioncel O, Rosano G. Pre-discharge and early post-discharge management of patients hospitalized for acute heart failure: A scientific statement by the Heart Failure Association of the ESC. Eur J Heart Fail. 2023 Jul;25(7):1115-1131. doi: 10.1002/ejhf.2888. Epub 2023 Jul 13.
PubMed 374482101. Telo GH, Saadi MP, Silvano GP, Silveira AD da, Biolo A. Contribution of Lung Ultrasound and VExUS in the Diagnosis and Monitoring of Patients with Heart Failure. ABC Heart Fail Cardiomyop. 2024;4(1).
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Ultrasound Intervention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07469722
- Acronym / sponsor ID
- POINTER-HF / 2025-0708
- Conditions
- Acute Heart Failure (AHF), Congestive Heart Failure Acute, Diuretic Effect, Lung Ultrasonography Score, Ultrasonography, Doppler, Point-of-care Ultrasound (POCUS)
- Keywords
- Acute Heart Failure, Congestive Heart Failure, Point-of-Care Ultrasound, Lung Ultrasound, Venous Excess Ultrasound, Diuretic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute decompensated heart failure (ADHF) is a frequent cause of hospitalization and is associated with high morbidity and mortality. Congestion is the primary pathophysiological mechanism leading to clinical deterioration and hospitalization in ADHF. Diuretics remain the cornerstone of treatment for most ADHF phenotypes; however, evidence regarding optimal strategies to guide diuretic therapy during the decongestion process is limited. Recently, point-of-care ultrasound (POCUS) has emerged as a promising tool to support clinical assessment in ADHF, improving diagnostic accuracy, prognostication, and pre-discharge evaluation. Nevertheless, the role of POCUS in guiding therapeutic management in ADHF remains uncertain. To specifically assess congestion in patients with ADHF, a pragmatic POCUS-based score, the Dynamic Ultrasound Congestion Score (DUCS), was developed. DUCS integrates lung ultrasound and Venous Excess Ultrasound (VExUS) to dynamically evaluate congestion severity, treatment response, and therapeutic goals during ADHF management. Observational data suggest that DUCS is associated with in-hospital outcomes and short-term prognosis, and correlates with markers of decongestion such as urinary output and weight loss. This study is a randomized, single-center, single-blind clinical trial designed to evaluate whether a DUCS-guided POCUS strategy improves clinical and decongestion outcomes compared with standard of care. Eligible patients hospitalized due to ADHF will be randomized within 48 hours of admission to one of two groups: (1) diuretic treatment guided by institutional standard-of-care combined with information from the EVEREST congestion score assessment and guideline-based treatment recommendations; or (2) diuretic treatment guided by serial DUCS-based POCUS assessments used to inform diuretic adjustment recommendations. Participants in both groups will undergo evaluations at baseline (day 1), day 2, day 3 and day 5, including clinical data collection, physical examination using the EVEREST congestion score, and standardized DUCS-based POCUS assessments. Outcomes to be assessed include in-hospital mortality, length of hospital stay, decongestion parameters, and changes in biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: Furosemide 40 Milligrams., Drug: Dapagliflozin (10mg Tab)Standard of care with additional information from the EVEREST congestion score and guideline-based treatment recommendations. Diuretics will be administered intravenously according to the institutional standard of care, with results from the EVEREST congestion score assessment and guideline-based treatment recommendations provided to the treating medical team. Dapagliflozin will also be suggested as part of guideline-directed medical therapy for patients without contraindications. |
| Diuretic therapy guided by DUCS-based POCUS | Experimental | Drug: Furosemide 40 Milligrams., Drug: Hydrochlorothiazide (HCTZ) 25 milligrams., Drug: Acetazolamide 250 milligrams., Drug: Dapagliflozin (10mg Tab), Drug: Potassium Chloride Oral ProductTreatment recommendation will be made according to baseline DUCS-based POCUS assessment, as follows: Patients with DUCS 2-4 points (defined as mild to moderate congestion): the recommended intravenous loop diuretic dose will be twice the patient's previous total daily oral dose. If no diuretics were taken previously, intravenous furosemide 40 mg three times daily will be administered. Patients with DUCS ≥ 5 points (defined as severe congestion): the recommended intravenous loop diuretic dose will be twice the patient's previous total daily oral dose. If no diuretics were taken previously, intravenous furosemide 40 mg three times daily will be administered. Addition of a second diuretic will be recommended, either oral hydrochlorothiazide or oral acetazolamide, according to serum electrolyte levels. Serial DUCS-based POCUS assessments will provide recommendations for diuretic therapy adjustments. Dapagliflozin and oral potassium supplements will also be suggested if appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women aged 18 years or older.
- Diagnosis of acute decompensated heart failure (ADHF) with left ventricular ejection fraction <50%, presenting with symptoms (dyspnea, orthopnea, fatigue) and/or signs (pulmonary crackles, peripheral edema, jugular venous distension, hepatomegaly, hepatojugular reflux) of decompensated heart failure.
- Brain natriuretic peptide (BNP) ≥ 300 pg/mL.
- Signs of systemic and/or pulmonary congestion on POCUS, defined as DUCS ≥ 3 points.
- Time from hospital admission ≤ 48 hours.
Key exclusion criteria (13 listed)
- Patients under evaluation for heart transplantation or with prior heart transplantation.
- Acute coronary syndrome as the primary cause of hospitalization.
- Evidence of uncontrolled infection.
- Cardiac surgery or percutaneous coronary or structural cardiac intervention within the previous 30 days.
- Signs of hypoperfusion, defined as any of the following: mean arterial pressure < 60 mmHg, capillary refill time > 4 seconds, arterial lactate > 2 mmol/L or venous lactate > 2.5 mmol/L.
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 |
|---|---|---|
| Furosemide 40 Milligrams.Decongestive therapy with intravenous furosemide, with or without oral hydrochlorothiazide and/or oral acetazolamide, will be adjusted based on DUCS-based POCUS assessments. Procedure: DUCS-based POCUS protocol DUCS ranges from 0 to 10 points and is divided into three categories: absence of congestion (<2 points), mild to moderate congestion (2-4 points) and severe congestion (≥5 points). DUCS integrates eight-zone lung ultrasound (each zone considered positive in the presence of ≥3 B-lines) and modified VExUS (inferior vena cava, portal vein and hepatic vein Doppler) assessments. For lung ultrasound, 2-3 positive zones score 2 points, 4-5 score 4 points and ≥6 score 5 points. For modified VExUS, grade 1 scores 1 point, grade 2 scores 2 points, and grade 3 scores 5 points. The final DUCS value is calculated as the sum of both components. | Drug | Diuretic therapy guided by DUCS-based POCUS |
| Furosemide 40 Milligrams.Procedure: physical examination according to the EVEREST congestion score and guideline-based treatment recommendations. Results from the physical examination will be provided to the medical team in the form of the EVEREST composite congestion score (CCS), which ranges from 0 to 9 and incorporates evaluation of jugular venous distension, pedal edema, and orthopnea. General guideline-based recommendations for the management of ADHF will be provided to the medical team. | Drug | Standard of care |
| Hydrochlorothiazide (HCTZ) 25 milligrams.Addition of a second diuretic will be recommended, either oral hydrochlorothiazide or oral acetazolamide, according to serum potassium and bicarbonate levels. Hydrochlorothiazide dose will be defined according to serum creatinine and estimated glomerular filtration rate (eGFR). | Drug | Diuretic therapy guided by DUCS-based POCUS |
| Acetazolamide 250 milligrams.Addition of a second diuretic will be recommended, either oral hydrochlorothiazide or oral acetazolamide, according to serum potassium, serum bicarbonate, and estimated glomerular filtration rate (eGFR). | Drug | Diuretic therapy guided by DUCS-based POCUS |
| Dapagliflozin (10mg Tab)Dapagliflozin will be suggested to the treating medical team as part of guideline-directed medical therapy for patients without contraindications. | Drug | Diuretic therapy guided by DUCS-based POCUS, Standard of care |
| Potassium Chloride Oral ProductOral potassium chloride supplementation will be administered to patients with serum potassium < 4.0 mEq/L in the experimental group. | Drug | Diuretic therapy guided by DUCS-based POCUS |
Primary outcome
Pairwise Comparisons With Wins of Clinical Benefit, a Composite of In-Hospital Mortality, Hospital Length of Stay, Absence of Congestion on DUCS at Discharge, and BNP Reduction From Admission to Day 7 or Discharge.
Time frame: From randomization until hospital discharge (assessed up to 90 days).
Clinical benefit will be assessed using a hierarchical composite endpoint based on pairwise comparisons (win ratio analysis), including the following components, analyzed in a predefined hierarchical order: 1. In-hospital mortality: death is worse than no death; earlier death is worse than later death; tied if not possible to determine. 2. Hospital length of stay (days): a shorter hospital length of stay is better; a difference of ≥1 day defines a win; tied if the same number of length of stay days. 3. Absence of congestion on DUCS at discharge: <2 points at discharge on DUCS is better; tied if both have ≥2 points or if both have <2 points on DUCS. 4. BNP reduction at day 7 or discharge (whichever occurs first): a reduction of ≥30% in BNP is better; tied if both achieve or do not achieve a ≥30% reduction.
12 secondary outcomes
All-cause in-hospital mortality.
Time frame: From randomization until hospital discharge (assessed up to 90 days).
Hospital length of stay.
Time frame: From randomization until hospital discharge (assessed up to 90 days).
Proportion of patients without congestion on POCUS at discharge.
Time frame: From randomization until hospital discharge (assessed up to 90 days).
BNP reduction.
Time frame: From randomization until hospital discharge (assessed up to 90 days).
Change in body weight.
Time frame: From randomization until hospital discharge (assessed up to 90 days).
Change in dyspnea assessed by the Visual Analogue Scale (VAS).
Time frame: Up to day 5.
Proportion of participants with worsening renal function.
Time frame: Up to day 7.
Proportion of patients without congestion on EVEREST at discharge.
Time frame: From randomization until hospital discharge (assessed up to 90 days).
In-hospital mortality and major in-hospital clinical events.
Time frame: From randomization until hospital discharge (assessed up to 90 days).
All-cause mortality or rehospitalization within 30 days.
Time frame: From hospital discharge up to 30 days.
All-cause mortality or rehospitalization within 90 days.
Time frame: From hospital discharge up to 90 days.
Proportion of participants with electrolyte abnormalities
Time frame: From randomization until hospital discharge (assessed up to 90 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 37448210Metra M, Adamo M, Tomasoni D, Mebazaa A, Bayes-Genis A, Abdelhamid M, Adamopoulos S, Anker SD, Bauersachs J, Belenkov Y, Bohm M, Gal TB, Butler J, Cohen-Solal A, Filippatos G, Gustafsson F, Hill L, Jaarsma T, Jankowska EA, Lainscak M, Lopatin Y, Lund LH, McDonagh T, Milicic D, Moura B, Mullens W, Piepoli M, Polovina M, Ponikowski P, Rakisheva A, Ristic A, Savarese G, Seferovic P, Sharma R, Thum T, Tocchetti CG, Van Linthout S, Vitale C, Von Haehling S, Volterrani M, Coats AJS, Chioncel O, Rosano G. Pre-discharge and early post-discharge management of patients hospitalized for acute heart failure: A scientific statement by the Heart Failure Association of the ESC. Eur J Heart Fail. 2023 Jul;25(7):1115-1131. doi: 10.1002/ejhf.2888. Epub 2023 Jul 13.
- Background1. Telo GH, Saadi MP, Silvano GP, Silveira AD da, Biolo A. Contribution of Lung Ultrasound and VExUS in the Diagnosis and Monitoring of Patients with Heart Failure. ABC Heart Fail Cardiomyop. 2024;4(1).
- Individual participant dataSharing planned: Undecided
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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.
Luis E Rohde, Professor study chair
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Furosemide 40 Milligrams., Hydrochlorothiazide (HCTZ) 25 milligrams. and Acetazolamide 250 milligrams. in people with Acute Heart Failure (AHF) and Congestive Heart Failure Acute, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 18 Mar 2026. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrique C Scherer, MD (5551 33596246, henriquecscherer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pairwise Comparisons With Wins of Clinical Benefit, a Composite of In-Hospital Mortality, Hospital Length of Stay, Absence of Congestion on DUCS at Discharge, and BNP Reduction From Admission to Day 7 or Discharge. (time frame: From randomization until hospital discharge (assessed up to 90 days).). 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 NCT07469722, which also lists 2 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 18 Mar 2026.