Targeted lowering of central blood pressure in patients with hypertension: a randomised controlled trial

Not Applicable

Active, not recruiting

• Conditions: High blood pressure; Cardiovascular - Hypertension

• Registration Number: ACTRN12613000053729
• Lead Sponsor: James Sharman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

*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).

Exclusion Criteria

*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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eft ventricular mass by magnetic resonance imaging[2 years]

Secondary Outcome Measures

Name	Time	Method
Clinic and home blood pressures (measured using automated devices) and 24 hour ambulatory blood pressure.[2 years];Aortic stiffness by tonometry and magnetic resonance imaging[2 years];Quality of life using SF-36 and Bulpitt health surveys[2 years]