Inorganic nitrate as a treatment for acute heart failure: a protocol for a single center, randomized, double-blind, placebo-controlled pilot and feasibility study

Journal of Translational Medicine

Protocol

Sabine Braat¹  Joshua Sortino²  Jason D. Allen³  Roman Falls⁴  Michael Seman⁴  Christopher J. Neil⁵ 

[1] Department of Medicine-Western Health, Melbourne Medical School, The University of Melbourne, Melbourne, Australia;Melbourne School of Population and Global Health and Melbourne Clinical and Translational Sciences Platform (MCATS), Parkville, Australia;Western Centre for Health Research and Education, Western Health, Melbourne, Australia;Western Centre for Health Research and Education, Western Health, Melbourne, Australia;Clinical Exercise Science Research Program, Institute of Sport Exercise and Active Living (ISEAL), Melbourne, Australia;Western Centre for Health Research and Education, Western Health, Melbourne, Australia;Department of Medicine-Western Health, Melbourne Medical School, The University of Melbourne, Melbourne, Australia;Western Centre for Health Research and Education, Western Health, Melbourne, Australia;Department of Medicine-Western Health, Melbourne Medical School, The University of Melbourne, Melbourne, Australia;Clinical Exercise Science Research Program, Institute of Sport Exercise and Active Living (ISEAL), Melbourne, Australia;Western Health Cardiology, Footscray Hospital, Gordon St, Locked Bag 2, 3011, Footscray, VIC, Australia;

关键词: Heart failure;    Acute heart failure;    Acute decompensated heart failure;    Sodium nitrate;    Nitric oxide;    Non-invasive cardiovascular monitoring;   

DOI  :  10.1186/s12967-017-1271-z

 received in 2016-07-24, accepted in 2017-07-24,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundAcute heart failure (AHF) is a frequent reason for hospitalization worldwide and effective treatment options are limited. It is known that AHF is a condition characterized by impaired vasorelaxation, together with reduced nitric oxide (NO) bioavailability, an endogenous vasodilatory compound. Supplementation of inorganic sodium nitrate (NaNO3) is an indirect dietary source of NO, through bioconversion. It is proposed that oral sodium nitrate will favorably affect levels of circulating NO precursors (nitrate and nitrite) in AHF patients, resulting in reduced systemic vascular resistance, without significant hypotension.Methods and outcomesWe propose a single center, randomized, double-blind, placebo-controlled pilot trial, evaluating the feasibility of sodium nitrate as a treatment for AHF. The primary hypothesis that sodium nitrate treatment will result in increased systemic levels of nitric oxide pre-cursors (nitrate and nitrite) in plasma, in parallel with improved vasorelaxation, as assessed by non-invasively derived systemic vascular resistance index. Additional surrogate measures relevant to the known pathophysiology of AHF will be obtained in order to assess clinical effect on dyspnea and renal function.DiscussionThe results of this study will provide evidence of the feasibility of this novel approach and will be of interest to the heart failure community. This trial may inform a larger study.

【 授权许可】

CC BY   
© The Author(s) 2017

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