TACTIC-HF: Sequential Diuretic Strategies in Ambulatory Worsening Heart Failure (TACTIC-HF)
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:
- 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.
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Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Lucrecia Maria Burgos, MD
- Número de telefone: 541147877500
- E-mail: lburgos@icba.com.ar
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Intravenous Furosemide
Participants receive outpatient intravenous furosemide according to the study protocol during a structured ambulatory treatment session.
|
Intravenous loop diuretic therapy administered during outpatient treatment sessions according to protocol-defined dosing categories.
|
|
Experimental: Intravenous Furosemide + Acetazolamide
Participants receive outpatient intravenous furosemide combined with oral acetazolamide during a structured ambulatory treatment session
|
Intravenous loop diuretic therapy administered during outpatient treatment sessions according to protocol-defined dosing categories.
Oral acetazolamide administered prior to intravenous loop diuretic therapy during outpatient treatment sessions
|
|
Experimental: Intravenous Furosemide + Hydrochlorothiazide
Participants receive outpatient intravenous furosemide combined with oral hydrochlorothiazide during a structured ambulatory treatment session
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Intravenous loop diuretic therapy administered during outpatient treatment sessions according to protocol-defined dosing categories.
Oral hydrochlorothiazide administered prior to intravenous loop diuretic therapy during outpatient treatment sessions.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total Urinary Sodium Excretion at 6 Hours
Prazo: 6 hours
|
Total urine volume collected during the outpatient treatment session
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6 hours
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Mullens 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.
- Trullas 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.
- 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.
Datas de registro do estudo
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Início do estudo (Estimado)
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- TACTIC-HF
- 2 (Instituto Cardiovascular de Buenos Aires)
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