Investigation of Dietary Nitrate Effects in Hypertension-induced Target Organ Damage (NCT03088514) | Clinical Trial Compass
CompletedPhase 2
Investigation of Dietary Nitrate Effects in Hypertension-induced Target Organ Damage
United Kingdom149 participantsStarted 2017-03-23
Plain-language summary
This study aims to determine whether dietary inorganic nitrate (in beetroot juice) is able to reduce overall thickening of the heart (left ventricular hypertrophy or LVH) and stiffness of the arteries when given to patients with persistently raised blood pressure (hypertension). Half the patients will receive the beetroot juice containing inorganic nitrate and half will receive beetroot juice from which the inorganic nitrate has been removed. The volunteers will take the juice every day for 4 months.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol restrictions.
✓. Aged 18-80 years.
✓. The study subjects will be hypertensives with evidence of difficulty treating to target BP (daytime ABPM 135-170/85-105 mmHg) on 1 or more antihypertensive agents, with insufficient efficacy or intolerance of medications.
✓. For NITRATE LVH, echocardiographic evidence of LV hypertrophy (LV mass indexed to body surface area (BSA); males \>115g/m2; females \>95 g/m2).
✓. Patients will have been established on an antihypertensive treatment regime for at least 1 month by the time of participation in the study and will not require changes in pharmacological intervention for the duration of the trial.
Exclusion criteria
✕. History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders.
✕. History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, 3x above the upper limit of normal or bilirubin 1.5x above the upper limit of normal at screening.
✕. Renal impairment with creatinine clearance (eGFR) of \<50 ml/min at screening.
✕. Patients with diabetes mellitus, defined by previous history of diabetes or HbA1c \>6.5% (\>48 mmol/mol) at screening.
✕. Subjects with LDLc, \>7.5 mmol/l. TG level \>10mmol/l.
✕. History of heart failure defined as NYHA class II - IV or those with known LV dysfunction (EF\<40%) regardless of symptomatic status
✕. History of malignancy within the past 5 years, other than non-melanoma skin cancer.
✕. Current life-threatening condition other than vascular disease (e.g. very severe chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent a subject from completing the study.