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TACTIC-HF: Sequential Diuretic Strategies in Ambulatory Worsening Heart Failure

ConditionAcute Heart Failure (AHF)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLucrecia Maria Burgos

About this 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:

1. intravenous furosemide alone, 2. intravenous furosemide combined with oral acetazolamide, and 3. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Intravenous furosemide bolus injections

    Drug

    Intravenous loop diuretic therapy administered during outpatient treatment sessions according to protocol-defined dosing categories.

  • ACETAZOLAMIDE oral capsule

    Drug

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Intravenous FurosemideActive comparator 1 intervention
Group B: Intravenous Furosemide + AcetazolamideExperimental treatment 2 interventions
Group C: Intravenous Furosemide + HydrochlorothiazideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Total Urinary Sodium Excretion at 6 Hours

Total urine volume collected during the outpatient treatment session

Time frame
6 hours

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lucrecia Maria Burgos

Lead sponsor

Instituto Cardiovascular de Buenos Aires

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: