Diuretic Strategies in Acute Heart Failure and Renal Dysfunction: Conventional vs Carbohydrate Antigen 125-guided Strategy. Clinical Trial Design

• Published in: Revista española de cardiología (English ed.) Vol. 70; no. 12; pp. 1067 - 1073
• Main Authors: García-Blas, Sergio, Bonanad, Clara, Llàcer, Pau, Ventura, Silvia, Núñez, José María, Sánchez, Ruth, Chamorro, Carlos, Fácila, Lorenzo, de la Espriella, Rafael, Vaquer, Juana María, Cordero, Alberto, Roqué, Mercè, Ortiz, Víctor, Racugno, Paolo, Bodí, Vicent, Valero, Ernesto, Santas, Enrique, Moreno, María del Carmen, Miñana, Gema, Carratalá, Arturo, Bondanza, Lourdes, Payá, Ana, Cardells, Ingrid, Heredia, Raquel, Pellicer, Mauricio, Valls, Guillermo, Palau, Patricia, Bosch, María José, Raso, Rafael, Sánchez, Andrés, Bertomeu-González, Vicente, Bertomeu-Martínez, Vicente, Montagud-Balaguer, Vicente, Albiach-Montañana, Cristina, Pendás-Meneau, Jezabel, Marcaida, Goitzane, Cervantes-García, Sonia, San Antonio, Rodolfo, de Mingo, Elisabet, Chorro, Francisco J, Sanchis, Juan, Núñez, Julio
• Format: Journal Article
• Language: English
• Published: Spain 01-12-2017
• Subjects: Acetazolamide - therapeutic use; Acute Disease; CA-125 Antigen - blood; Cardio-Renal Syndrome - blood; Cardio-Renal Syndrome - complications; Cardio-Renal Syndrome - drug therapy; Cardiovascular; Chlorthalidone - therapeutic use; Creatinine - blood; Diuretics - therapeutic use; Furosemide - therapeutic use; Heart Failure - blood; Heart Failure - complications; Heart Failure - drug therapy; Humans; Internal Medicine; Membrane Proteins - blood; Patient Care Planning; Water-Electrolyte Imbalance - blood; Water-Electrolyte Imbalance - drug therapy; Water-Electrolyte Imbalance - etiology; Heart failure; Biomarker guided therapy; WRF; Clinical outcomes; worsening of renal function; Cr; creatinine; Antígeno carbohidrato 125; Renal failure; Insuficiencia cardiaca; CA125; Clinical trial; Insuficiencia renal; acute heart failure; Terapia guiada por biomarcadores; Eventos clínicos; Ensayo clínico; HF; Carbohydrate antigen 125; AHF
• ISSN: 1885-5857; 1885-5857
• DOI: 10.1016/j.rec.2017.02.028

Abstract Introduction and objectives The optimal treatment of patients with acute heart failure (AHF) and cardiorenal syndrome type 1 (CRS-1) is far from being well-defined. Arterial hypoperfusion in concert with venous congestion plays a crucial role in the pathophysiology of CRS-I. Plasma carbohydrate antigen 125 (CA125) has emerged as a surrogate of fluid overload in AHF. The aim of this study was to evaluate the clinical usefulness of CA125 for tailoring the intensity of diuretic therapy in patients with CRS-1. Methods Multicenter, open-label, parallel clinical trial, in which patients with AHF and serum creatinine ≥ 1.4 mg/dL on admission will be randomized to: a) standard diuretic strategy: titration-based on conventional clinical and biochemical evaluation, or b) diuretic strategy based on CA125: high dose if CA125 > 35 U/mL, and low doses otherwise. The main endpoint will be renal function changes at 24 and 72 hours after therapy initiation. Secondary endpoints will include: a) clinical and biochemical changes at 24 and 72 hours, and b) renal function changes and major clinical events at 30 days. Results The results of this study will add important knowledge on the usefulness of CA125 for guiding diuretic treatment in CRS-1. In addition, it will pave the way toward a better knowledge of the pathophysiology of this challenging situation. Conclusions We hypothesize that higher levels of CA125 will identify a patient population with CRS-1 who could benefit from the use of a more intense diuretic strategy. Conversely, low levels of this glycoprotein could select those patients who would be harmed by high diuretic doses.