Joan Carles Trullàs1, José Luís Morales-Rull2, Jesús Casado3, Adriana Freitas Ramírez4, Luís Manzano5, Francesc Formiga6. 1. Internal Medicine Service, Hospital d'Olot, Girona, Spain; Medical Science Department, University of Girona, Spain. Electronic address: jctv5153@comg.cat. 2. Internal Medicine Service, Hospital Arnau de Vilanova, Lleida, Spain. 3. Internal Medicine Service, Hospital de Getafe, Madrid, Spain. 4. Departament de Salut, Generalitat de Catalunya, Servei d'Informació i Estudis, Barcelona, Spain. 5. Internal Medicine Service, Hospital Univ. Ramón y Cajal, Universidad de Alcalá, Madrid, Spain. 6. Internal Medicine Service, Hospital Universitari de Bellvitge-IDIBELL, Hospitalet del Llobregat, Barcelona, Spain.
Abstract
BACKGROUND:Fluid overload refractory to loop diuretic therapy can complicate acute or chronic heart failure (HF) management. The Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure (CLOROTIC) trial (Clinicaltrials.gov identifier NCT01647932) will test the hypothesis that blocking distal tubule sodium reabsorption with hydrochlorothiazide can antagonize the renal adaptation to chronic loop diuretic therapy and improve diuretic resistance. METHODS: CLOROTIC is a randomized, placebo-controlled, double-blind, multicenter study. Three hundred and four patients with decompensated HF will be randomly assigned to receive hydrochlorothiazide or placebo in addition to a furosemide regimen. The main inclusion criteria are: age ≥18 years, history of chronic HF (irrespective of etiology and/or ejection fraction), admission for acute decompensation, and previous treatment with an oral loop diuretic for at least 1 month before randomization. The 2 coprimary endpoints are changes in body weight and changes in patient-reported dyspnea during hospital admission. Morbidity, mortality, and safety aspects will also be addressed. CONCLUSIONS: CLOROTIC is the first large-scale trial to evaluate whether the addition of a thiazide diuretic (hydrochlorothiazide) to a loop diuretic (furosemide) is a safe and effective strategy for improving congestive symptoms resulting from HF. This trial will provide important information and will therefore have a major impact on treatment strategies and future trials in these patients.
RCT Entities:
BACKGROUND: Fluid overload refractory to loop diuretic therapy can complicate acute or chronic heart failure (HF) management. The Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure (CLOROTIC) trial (Clinicaltrials.gov identifier NCT01647932) will test the hypothesis that blocking distal tubule sodium reabsorption with hydrochlorothiazide can antagonize the renal adaptation to chronic loop diuretic therapy and improve diuretic resistance. METHODS: CLOROTIC is a randomized, placebo-controlled, double-blind, multicenter study. Three hundred and four patients with decompensated HF will be randomly assigned to receive hydrochlorothiazide or placebo in addition to a furosemide regimen. The main inclusion criteria are: age ≥18 years, history of chronic HF (irrespective of etiology and/or ejection fraction), admission for acute decompensation, and previous treatment with an oral loop diuretic for at least 1 month before randomization. The 2 coprimary endpoints are changes in body weight and changes in patient-reported dyspnea during hospital admission. Morbidity, mortality, and safety aspects will also be addressed. CONCLUSIONS: CLOROTIC is the first large-scale trial to evaluate whether the addition of a thiazide diuretic (hydrochlorothiazide) to a loop diuretic (furosemide) is a safe and effective strategy for improving congestive symptoms resulting from HF. This trial will provide important information and will therefore have a major impact on treatment strategies and future trials in these patients.
Authors: Ovidiu Chioncel; Sean P Collins; Andrew P Ambrosy; Peter S Pang; Elena-Laura Antohi; Vlad Anton Iliescu; Aldo P Maggioni; Javed Butler; Alexandre Mebazaa Journal: Am J Ther Date: 2018 Jul/Aug Impact factor: 2.688
Authors: Christopher S Wilcox; Wen Shen; David W Boulton; Bruce R Leslie; Steven C Griffen Journal: J Am Heart Assoc Date: 2018-02-10 Impact factor: 5.501