Effect on left ventricular mass with targeted lowering of central blood pressure using spironolactone in patients with hypertension: a randomised controlled trial

James Sharman0 sites300 target enrollmentJanuary 16, 2013

Overview

No summary available.

Registry

who.int

Start Date

January 16, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

James Sharman

•\*Aged 18 – 70 years on stable antihypertensive therapy (at least one month).
•\*Taking at least one, but no more than three, antihypertensive drugs to lower BP (rationale for no more than 3 drugs is that this will rule out cases of complicated or resistant hypertension which may require special attention beyond this study protocol).
•\*Seated brachial BP \<140/90 mmHg (controlled brachial BP).
•\*Seated central SBP greater than or equal to \+0\.5SD of age\- and gender\-specific normal values (uncontrolled central BP).

•\*Seated brachial BP greater than or equal to 140/90 mmHg (uncontrolled brachial BP)
•\*Seated brachial BP \<140/90 mmHg but central SBP below \+0\.5SD of age\- and gender\-specific normal values
•\*Women who are pregnant, breastfeeding or of child bearing age with intending pregnancy.
•\*Concomitant therapy with both ACEi and ARB (due to risk of hyperkalaemia).
•\*Therapy with digoxin or lithium or nondepolarizing skeletal muscle relaxants (e.g. Tubocurarine).
•\*A clinical history of CVD which may affect estimation of central BP or complicate therapeutic decisions. This includes; established coronary artery disease, coronary artery bypass graft surgery, aortic valve stenosis (gradient \>20 mmHg), systolic heart failure or ejection fraction \<50% or other serious cardiovascular event within 6 months of enrolment.
•\*Chronic use of sex hormone therapy or non\-steroidal anti\-inflammatory drugs
•\*Using any aldosterone inhibitor (eplereone, spironolactone) within 30 days of enrolment.
•\*Contraindication to spironolactone including; anuria, acute renal insufficiency, significant impairment of renal excretory function (creatinine clearance less than or equal to 50 mL/min \[Cockcroft\-Gault formula]) or hyperkalemia (plasma potassium \>5\.0 mmol/l at initiation).
•\*Using potassium supplements or potassium\-sparing diuretics (e.g. amiloride or triamterene).