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Randomised, double-blind, placebo-controlled clinical trial investigating the effects of inorganic nitrate in hypertension-induced target organ damage: protocol of the NITRATE-TOD study in the UK.
- Source :
-
BMJ open [BMJ Open] 2020 Jan 21; Vol. 10 (1), pp. e034399. Date of Electronic Publication: 2020 Jan 21. - Publication Year :
- 2020
-
Abstract
- Introduction: Arterial stiffness and left ventricular (LV) hypertrophy are the key markers of hypertensive target organ damage (TOD) associated with increased cardiovascular morbidity and mortality. We have previously shown that dietary inorganic nitrate supplementation lowers blood pressure (BP) in hypertension, however, whether this approach might also improve markers of hypertensive TOD is unknown. In this study, we will investigate whether daily dietary inorganic nitrate administration reduces LV mass and improves measures of arterial stiffness.<br />Methods and Design: NITRATE-TOD is a double-blind, randomised, single-centre, placebo-controlled phase II trial aiming to enrol 160 patients with suboptimal BP control on one or more antihypertensives. Patients will be randomised to receive 4 months once daily dose of either nitrate-rich beetroot juice or nitrate-deplete beetroot juice (placebo). The primary outcomes are reduction in LV mass and reduction in pulse wave velocity (PWV) and central BP.The study has a power of 95% for detecting a 9 g LV mass change by cardiovascular MRI (~6% change for a mildly hypertrophied heart of 150 g). For PWV, we have a power of >95% for detecting a 0.6 m/s absolute change. For central systolic BP, we have a>90% power to detect a 5.8 mm Hg difference in central systolic BP.Secondary end points include change in ultrasound flow-mediated dilation, change in plasma nitrate and nitrite concentration and change in BP.<br />Ethics and Dissemination: The study was approved by the London-City and East Research Ethics Committee (10/H0703/98). Trial results will be published according to the Consolidated Standards of Reporting Trials statement and will be presented at conferences and reported in peer-reviewed journals.<br />Trial Registration Number: NCT03088514.<br />Competing Interests: Competing interests: AA is a codirector of Heartbeet Ltd, which is a start-up company that seeks to identify commercial potential of dietary nitrate.<br /> (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Dietary Supplements
Double-Blind Method
Female
Humans
Hypertension physiopathology
Male
Middle Aged
Pulse Wave Analysis
United Kingdom
Young Adult
Blood Pressure drug effects
Hypertension drug therapy
Nitrates therapeutic use
Vascular Stiffness drug effects
Subjects
Details
- Language :
- English
- ISSN :
- 2044-6055
- Volume :
- 10
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- BMJ open
- Publication Type :
- Academic Journal
- Accession number :
- 31969369
- Full Text :
- https://doi.org/10.1136/bmjopen-2019-034399