Financiado en parte por Fukuda Denshi Ltd
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
Faconti L, Mills CE, Govoni V, Gu H, Morant S, Jiang B, Cruickshank JK, Webb AJ
British journal of clinical pharmacology · 28 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiado por la industria
- Gobierno
- National Institute for Health and Care Research
- Universidad u hospital
- King's College London
- Universidad u hospital
- NIHR Biomedical Research Centre based at Guy's and St Thomas' NHS Foundation Trust and King's College London
- Empresa
- Fukuda Denshi Ltd
Según 4 financiadores declarados.
Publicación
- Publicado
- 2018-10-08 · Br J Clin Pharmacol · vol. 85 · número 1 · págs. 169–180
- Editorial
- Wiley
- Citado
- 30 citas · más que el 85% de estudios similares · 1.8× el promedio de su campo
- Referencias
- 58 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Nitric Oxide and Endothelin Effects · Hormonal Regulation and Hypertension · Sodium Intake and Health
- Palabras clave
- Spironolactone, Doxazosin, Medicine, Type 2 diabetes, Placebo, Internal medicine, Blood pressure, Population, Heart failure, Cardiology, Diabetes mellitus, Endocrinology, Urology
- MeSH
- heart, humans, beta vulgaris, hypertension, diabetes mellitus, type 2, nitrates, spironolactone, doxazosin, placebos, echocardiography, treatment outcome, double-blind method, blood pressure, adult, aged, middle aged, female, male, heart failure, vascular stiffness, pulse wave analysis, fruit and vegetable juices
8 autores
- Luca Faconti🇬🇧King's College London; Guy's and St Thomas' NHS Foundation Trust; British Heart Foundation; King's College School
- Charlotte Elizabeth Mills🇬🇧King's College London; Guy's and St Thomas' NHS Foundation Trust; King's College School
- V. Govoni🇬🇧King's College London; Guy's and St Thomas' NHS Foundation Trust; King's College School
- Haotian Gu🇬🇧King's College London; Guy's and St Thomas' NHS Foundation Trust; British Heart Foundation
- S. V. Morant🇬🇧University of Dundee
- Benju Jiang🇬🇧King's College London; Guy's and St Thomas' NHS Foundation Trust; British Heart Foundation
- J. CRUICKSHANK🇬🇧King's College London; Guy's and St Thomas' NHS Foundation Trust; King's College School
- David J. Webb🇬🇧 · autor de correspondenciaKing's College London; Guy's and St Thomas' NHS Foundation Trust; British Heart Foundation
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
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