Cardiac effects of 6 months' dietary nitrate and spironolactone in patients with hypertension and with/at risk of type 2 diabetes, in the factorial design, double-blind, randomized controlled VaSera trial

Br J Clin Pharmacol. 2019 Jan;85(1):169-180. doi: 10.1111/bcp.13783. Epub 2018 Nov 13.

Abstract

Aims: The aims of the present study were to explore whether a long-term intervention with dietary nitrate [(NO3- ), a potential tolerance-free source of beneficial vasoactive nitric oxide] and spironolactone (to oppose aldosterone's potential deleterious cardiovascular effects) improve cardiac structure/function, independently of blood pressure (BP), in patients with/at risk of type 2 diabetes (a population at risk of heart failure).

Methods: A subsample of participants in our double-blind, randomized, factorial-design intervention (VaSera) trial of active beetroot juice as a nitrate source (≤11.2 mmol) or placebo (nitrate depleted) beetroot juice, and either ≤50 mg spironolactone or ≤16 mg doxazosin (control), had transthoracic cardiac ultrasounds at baseline (n = 105), and at 3 months and 6 months (n = 87) after the start of the intervention. Analysis was by modified intent-to-treat.

Results: Nitrate-containing juice (n = 40) decreased left ventricular (LV) end-diastolic volume {-6.3 [95% confidence interval (CI) -11.1, -1.6] ml} and end-systolic volume [-3.2 (95% CI -5.9, -0.5) ml], and increased end-diastolic mass/volume ratio [+0.04 (95% CI 0.00, 0.07)], relative to placebo juice (n = 47). Spironolactone (n = 44) reduced relative wall thickness compared with doxazosin (n = 43) [-0.01 (95% CI -0.02, -0.00)]. Although spironolactone reduced LV mass index relative to baseline [-1.48 (95% CI -2.08, -0.88) g m-2.7 ], there was no difference vs. doxazosin [-0.85 (95% CI -1.76, 0.05) g m-2.7 ]. Spironolactone also decreased the E/A ratio [-0.12 (95% CI -0.19, -0.04)] and increased S' (a tissue-Doppler systolic function index) by 0.52 (95% CI 0.05, 1.0) cm s-1 . BP did not differ between the juices, or between the drugs.

Conclusions: Six months' dietary nitrate decreased LV volumes ~5%, representing new, sustained, BP-independent benefits on cardiac structure, extending mechanisms characterized in preclinical models of heart failure. Spironolactone's effects on cardiac remodelling and systolic-diastolic function, although confirmatory, were independent of BP.

Keywords: beetroot juice; cardiac remodelling; dietary nitrate; echocardiography; nitrate-nitrite-NO pathway; type 2 diabetes.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Beta vulgaris / chemistry
  • Blood Pressure / drug effects
  • Diabetes Mellitus, Type 2 / complications*
  • Double-Blind Method
  • Doxazosin / administration & dosage
  • Echocardiography
  • Female
  • Fruit and Vegetable Juices
  • Heart / diagnostic imaging
  • Heart / drug effects*
  • Heart Failure / etiology
  • Heart Failure / prevention & control*
  • Humans
  • Hypertension / complications
  • Hypertension / drug therapy
  • Male
  • Middle Aged
  • Nitrates / administration & dosage*
  • Placebos / administration & dosage
  • Pulse Wave Analysis
  • Spironolactone / administration & dosage*
  • Treatment Outcome
  • Vascular Stiffness / drug effects

Substances

  • Nitrates
  • Placebos
  • Spironolactone
  • Doxazosin