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Revista Española de Cardiología (English Edition) Revista Española de Cardiología (English Edition)
Rev Esp Cardiol. 2017;70:1067-73 - Vol. 70 Num.12 DOI: 10.1016/j.rec.2017.02.028

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

Sergio García-Blas a, Clara Bonanad a, Pau Llàcer b, Silvia Ventura c, José María Núñez d, Ruth Sánchez e, Carlos Chamorro e, Lorenzo Fácila f, Rafael de la Espriella f, Juana María Vaquer g, Alberto Cordero h, Mercè Roqué i, Víctor Ortiz j, Paolo Racugno a, Vicent Bodí a, Ernesto Valero a, Enrique Santas a, María del Carmen Moreno b, Gema Miñana a, Arturo Carratalá g, Lourdes Bondanza a, Ana Payá a, Ingrid Cardells a, Raquel Heredia a, Mauricio Pellicer a, Guillermo Valls c, Patricia Palau c, María José Bosch c, Rafael Raso e, Andrés Sánchez h, Vicente Bertomeu-González h, Vicente Bertomeu-Martínez h, Vicente Montagud-Balaguer f, Cristina Albiach-Montañana f, Jezabel Pendás-Meneau f, Goitzane Marcaida f, Sonia Cervantes-García f, Rodolfo San Antonio i, Elisabet de Mingo i, Francisco J. Chorro a, Juan Sanchis a, Julio Núñez a,

a Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universidad de Valencia, INCLIVA, Valencia, Spain
b Servicio de Medicina Interna, Hospital de Manises, Manises, Valencia, Spain
c Servicio de Cardiología, Hospital de La Plana, Villa-Real, Castellón, Spain
d Unidad de Cuidados Intensivos, Hospital Universitario del Vinalopó, Elche, Alicante, Spain
e Servicio de Medicina Interna, Hospital Virgen de Los Lirios, Alcoy, Alicante, Spain
f Servicio de Cardiología, Hospital General Universitario de Valencia, Valencia, Spain
g Servicio de Bioquímica, Hospital Clínico Universitario de Valencia, Universidad de Valencia, INCLIVA, Valencia, Spain
h Servicio de Cardiología, Hospital Universitario San Juan de Alicante, San Juan de Alicante, Alicante, Spain
i Servicio de Cardiología, Hospital Clínic de Barcelona, Barcelona, Spain
j Servicio de Medicina Interna, Hospital de Sagunto, Sagunto, Valencia, Spain

Keywords

Heart failure. Renal failure. Clinical trial. Biomarker guided therapy. Carbohydrate antigen 125. Clinical outcomes.

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.

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1885-5857/© 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved