Acute Heart Failure (AHF)Phase 4TACTIC-HFNCT07593612
TACTIC-HF: Sequential Diuretic Strategies in Ambulatory Worsening Heart Failure
A Phase 4 study testing Intravenous furosemide bolus injections, ACETAZOLAMIDE oral capsule and Hydrochlorothiazide (HCT) in people with Acute Heart Failure (AHF), run by Lucrecia Maria Burgos.
Trial summary
TACTIC-HF is a prospective randomized crossover trial designed to compare three ambulatory diuretic strategies in patients with worsening heart failure treated in a specialized heart failure day-hospital program. Participants will receive sequential treatment with: 1. intravenous furosemide alone, 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF)
- What is being tested?
- Intravenous furosemide bolus injections, ACETAZOLAMIDE oral capsule and Hydrochlorothiazide (HCT)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Jan 2027
- Phase
- Phase 4
- 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
- Age ≥18 years Chronic heart failure diagnosis according to current guideline definitions Ambulatory worsening heart failure requiring intravenous diuretic therapy in a specialized outpatient setting Evidence of clinical or objective congestion Chronic outpatient loop diuretic therapy Ability to comply with study procedures Written informed consent
Who cannot join
- Hemodynamic instability or cardiogenic shock Requirement for immediate hospitalization Acute coronary syndrome, active infection, pulmonary embolism, or uncontrolled arrhythmia Severe electrolyte abnormalities Advanced renal failure requiring dialysis Pregnancy or breastfeeding Contraindication or allergy to study medications Current treatment with acetazolamide or thiazide diuretics Any condition that, in the opinion of the investigators, would make study participation unsafe or interfere with study procedures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: TACTIC-HF: Thiazide or Acetazolamide Combination Versus Intravenous Furosemide in Ambulatory Worsening Heart Failure - a Randomized Crossover Trial
TACTIC-HF is a prospective randomized crossover trial designed to compare three ambulatory diuretic strategies in patients with worsening heart failure treated in a specialized heart failure day-hospital program.
Participants will receive sequential treatment with:
Read more
- intravenous furosemide alone,
- intravenous furosemide combined with oral acetazolamide, and
- intravenous furosemide combined with oral hydrochlorothiazide.
The primary objective is to compare short-term natriuretic response between strategies. Secondary objectives include assessment of urine output, congestion parameters, and renal/electrolyte safety.
Each participant will undergo repeated outpatient treatment sessions separated by washout periods, with standardized clinical and laboratory monitoring performed during each visit.
The study aims to evaluate pragmatic and clinically applicable ambulatory decongestion strategies using approved therapies commonly available in real-world practice.
Read the detailed description
Heart failure congestion remains one of the leading causes of hospitalization and recurrent healthcare utilization worldwide. Although loop diuretics represent the cornerstone of decongestive therapy, many patients develop suboptimal diuretic response or diuretic resistance during the course of chronic heart failure.
Sequential nephron blockade strategies combining loop diuretics with agents acting at different tubular sites may enhance natriuresis and improve decongestion. Recent inpatient studies have suggested potential benefits of acetazolamide- and thiazide-based strategies; however, evidence regarding ambulatory worsening heart failure management remains limited.
TACTIC-HF is a prospective, single-center, randomized, open-label crossover trial evaluating three commonly used outpatient decongestion strategies in patients with worsening heart failure treated in a dedicated heart failure day-hospital setting.
Participants will sequentially receive:
- intravenous furosemide alone,
- intravenous furosemide plus oral acetazolamide,
- intravenous furosemide plus oral hydrochlorothiazide.
Treatments will be administered during structured outpatient sessions with standardized monitoring and predefined washout intervals between treatment periods.
The primary endpoint is total urinary sodium excretion during the treatment session. Secondary endpoints include urine output, congestion-related parameters, and renal/electrolyte safety outcomes.
The study is designed as a pragmatic trial using approved therapies routinely available in clinical practice, with the objective of generating physiologically oriented evidence applicable to ambulatory heart failure care.
- Conditions
- Acute Heart Failure (AHF)
- Being tested
- Intravenous furosemide bolus injections, ACETAZOLAMIDE oral capsule, Hydrochlorothiazide (HCT)
- Keywords
- worsening heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous furosemide bolus injectionsDrug
Intravenous loop diuretic therapy administered during outpatient treatment sessions according to protocol-defined dosing categories.
ACETAZOLAMIDE oral capsuleDrug
Oral acetazolamide administered prior to intravenous loop diuretic therapy during outpatient treatment sessions
Hydrochlorothiazide (HCT)Drug
Oral hydrochlorothiazide administered prior to intravenous loop diuretic therapy during outpatient treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Furosemide | Active comparator | Participants receive outpatient intravenous furosemide according to the study protocol during a structured ambulatory treatment session. Receives: Drug: Intravenous furosemide bolus injections |
| Intravenous Furosemide + Acetazolamide | Experimental | Participants receive outpatient intravenous furosemide combined with oral acetazolamide during a structured ambulatory treatment session Receives: Drug: Intravenous furosemide bolus injections; Drug: ACETAZOLAMIDE oral capsule |
| Intravenous Furosemide + Hydrochlorothiazide | Experimental | Participants receive outpatient intravenous furosemide combined with oral hydrochlorothiazide during a structured ambulatory treatment session Receives: Drug: Intravenous furosemide bolus injections; Drug: Hydrochlorothiazide (HCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Urinary Sodium Excretion at 6 Hours
Total urine volume collected during the outpatient treatment session
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucrecia Maria Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucrecia Maria Burgos, Instituto Cardiovascular de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593612
- Sponsor's protocol ID
- TACTIC-HF
- Other IDs
- 2
- Acronym
- TACTIC-HF
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbo AR, Gruber A, Volis I, Aronson D, Girerd N, Lund Kristensen S, Zukermann R, Alberkant N, Sitnitsky E, Kruger A, Khasis P, Bravo E, Elad B, Helmer Levin L, Caspi O. Diuresis Efficacy in Ambulatory Congested Heart Failure Patients: Intrapatient Comparison of 3 Diuretic Regimens (DEA-HF). JACC Heart Fail. 2024 Aug;12(8):1396-1405. doi: 10.1016/j.jchf.2024.04.014. Epub 2024 May 11.
PubMed 38739124Trullas JC, Morales-Rull JL, Casado J, Carrera-Izquierdo M, Sanchez-Marteles M, Conde-Martel A, Davila-Ramos MF, Llacer P, Salamanca-Bautista P, Perez-Silvestre J, Plasin MA, Cerqueiro JM, Gil P, Formiga F, Manzano L; CLOROTIC trial investigators. Combining loop with thiazide diuretics for decompensated heart failure: the CLOROTIC trial. Eur Heart J. 2023 Feb 1;44(5):411-421. doi: 10.1093/eurheartj/ehac689.
PubMed 36423214Mullens W, Dauw J, Martens P, Verbrugge FH, Nijst P, Meekers E, Tartaglia K, Chenot F, Moubayed S, Dierckx R, Blouard P, Troisfontaines P, Derthoo D, Smolders W, Bruckers L, Droogne W, Ter Maaten JM, Damman K, Lassus J, Mebazaa A, Filippatos G, Ruschitzka F, Dupont M; ADVOR Study Group. Acetazolamide in Acute Decompensated Heart Failure with Volume Overload. N Engl J Med. 2022 Sep 29;387(13):1185-1195. doi: 10.1056/NEJMoa2203094. Epub 2022 Aug 27.
PubMed 36027559
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACTIC-HF: Thiazide or Acetazolamide Combination Versus Intravenous Furosemide in Ambulatory Worsening Heart Failure - a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07593612
- Acronym / sponsor ID
- TACTIC-HF / TACTIC-HF
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- worsening heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lucrecia Maria BurgosUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 18 May 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.
TACTIC-HF is a prospective randomized crossover trial designed to compare three ambulatory diuretic strategies in patients with worsening heart failure treated in a specialized heart failure day-hospital program.
Participants will receive sequential treatment with:
- intravenous furosemide alone,
- intravenous furosemide combined with oral acetazolamide, and
- intravenous furosemide combined with oral hydrochlorothiazide.
The primary objective is to compare short-term natriuretic response between strategies. Secondary objectives include assessment of urine output, congestion parameters, and renal/electrolyte safety.
Each participant will undergo repeated outpatient treatment sessions separated by washout periods, with standardized clinical and laboratory monitoring performed during each visit.
The study aims to evaluate pragmatic and clinically applicable ambulatory decongestion strategies using approved therapies commonly available in real-world practice.
Detailed description
Heart failure congestion remains one of the leading causes of hospitalization and recurrent healthcare utilization worldwide. Although loop diuretics represent the cornerstone of decongestive therapy, many patients develop suboptimal diuretic response or diuretic resistance during the course of chronic heart failure.
Sequential nephron blockade strategies combining loop diuretics with agents acting at different tubular sites may enhance natriuresis and improve decongestion. Recent inpatient studies have suggested potential benefits of acetazolamide- and thiazide-based strategies; however, evidence regarding ambulatory worsening heart failure management remains limited.
TACTIC-HF is a prospective, single-center, randomized, open-label crossover trial evaluating three commonly used outpatient decongestion strategies in patients with worsening heart failure treated in a dedicated heart failure day-hospital setting.
Participants will sequentially receive:
- intravenous furosemide alone,
- intravenous furosemide plus oral acetazolamide,
- intravenous furosemide plus oral hydrochlorothiazide.
Treatments will be administered during structured outpatient sessions with standardized monitoring and predefined washout intervals between treatment periods.
The primary endpoint is total urinary sodium excretion during the treatment session. Secondary endpoints include urine output, congestion-related parameters, and renal/electrolyte safety outcomes.
The study is designed as a pragmatic trial using approved therapies routinely available in clinical practice, with the objective of generating physiologically oriented evidence applicable to ambulatory heart failure care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous Furosemide | Active comparator | Drug: Intravenous furosemide bolus injectionsParticipants receive outpatient intravenous furosemide according to the study protocol during a structured ambulatory treatment session. |
| Intravenous Furosemide + Acetazolamide | Experimental | Drug: Intravenous furosemide bolus injections, Drug: ACETAZOLAMIDE oral capsuleParticipants receive outpatient intravenous furosemide combined with oral acetazolamide during a structured ambulatory treatment session |
| Intravenous Furosemide + Hydrochlorothiazide | Experimental | Drug: Intravenous furosemide bolus injections, Drug: Hydrochlorothiazide (HCT)Participants receive outpatient intravenous furosemide combined with oral hydrochlorothiazide during a structured ambulatory treatment session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18 years Chronic heart failure diagnosis according to current guideline definitions Ambulatory worsening heart failure requiring intravenous diuretic therapy in a specialized outpatient setting Evidence of clinical or objective congestion Chronic outpatient loop diuretic therapy Ability to comply with study procedures Written informed consent
Key exclusion criteria (1 listed)
- Hemodynamic instability or cardiogenic shock Requirement for immediate hospitalization Acute coronary syndrome, active infection, pulmonary embolism, or uncontrolled arrhythmia Severe electrolyte abnormalities Advanced renal failure requiring dialysis Pregnancy or breastfeeding Contraindication or allergy to study medications Current treatment with acetazolamide or thiazide diuretics Any condition that, in the opinion of the investigators, would make study participation unsafe or interfere with study procedures
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 |
|---|---|---|
| Intravenous furosemide bolus injectionsIntravenous loop diuretic therapy administered during outpatient treatment sessions according to protocol-defined dosing categories. | Drug | Intravenous Furosemide, Intravenous Furosemide + Acetazolamide, Intravenous Furosemide + Hydrochlorothiazide |
| ACETAZOLAMIDE oral capsuleOral acetazolamide administered prior to intravenous loop diuretic therapy during outpatient treatment sessions | Drug | Intravenous Furosemide + Acetazolamide |
| Hydrochlorothiazide (HCT)Oral hydrochlorothiazide administered prior to intravenous loop diuretic therapy during outpatient treatment sessions. | Drug | Intravenous Furosemide + Hydrochlorothiazide |
Primary outcome
Total Urinary Sodium Excretion at 6 Hours
Time frame: 6 hours
Total urine volume collected during the outpatient treatment session
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 May 2026.
- Background: PubMed 38739124Abbo AR, Gruber A, Volis I, Aronson D, Girerd N, Lund Kristensen S, Zukermann R, Alberkant N, Sitnitsky E, Kruger A, Khasis P, Bravo E, Elad B, Helmer Levin L, Caspi O. Diuresis Efficacy in Ambulatory Congested Heart Failure Patients: Intrapatient Comparison of 3 Diuretic Regimens (DEA-HF). JACC Heart Fail. 2024 Aug;12(8):1396-1405. doi: 10.1016/j.jchf.2024.04.014. Epub 2024 May 11.
- Background: PubMed 36423214Trullas JC, Morales-Rull JL, Casado J, Carrera-Izquierdo M, Sanchez-Marteles M, Conde-Martel A, Davila-Ramos MF, Llacer P, Salamanca-Bautista P, Perez-Silvestre J, Plasin MA, Cerqueiro JM, Gil P, Formiga F, Manzano L; CLOROTIC trial investigators. Combining loop with thiazide diuretics for decompensated heart failure: the CLOROTIC trial. Eur Heart J. 2023 Feb 1;44(5):411-421. doi: 10.1093/eurheartj/ehac689.
- Background: PubMed 36027559Mullens W, Dauw J, Martens P, Verbrugge FH, Nijst P, Meekers E, Tartaglia K, Chenot F, Moubayed S, Dierckx R, Blouard P, Troisfontaines P, Derthoo D, Smolders W, Bruckers L, Droogne W, Ter Maaten JM, Damman K, Lassus J, Mebazaa A, Filippatos G, Ruschitzka F, Dupont M; ADVOR Study Group. Acetazolamide in Acute Decompensated Heart Failure with Volume Overload. N Engl J Med. 2022 Sep 29;387(13):1185-1195. doi: 10.1056/NEJMoa2203094. Epub 2022 Aug 27.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous furosemide bolus injections, ACETAZOLAMIDE oral capsule and Hydrochlorothiazide (HCT) in people with Acute Heart Failure (AHF), run by Lucrecia Maria Burgos.
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 1 inclusion and 1 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 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Lucrecia Maria Burgos, MD (541147877500, lburgos@icba.com.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Urinary Sodium Excretion at 6 Hours (time frame: 6 hours). 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 NCT07593612, which also lists 3 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 May 2026.