None listed
Conditions
Brief summary
High blood pressure, or hypertension, is a major cause of death worldwide and affects over 6 million Australians. Many people with high blood pressure do not achieve good blood pressure control even with more than one medication. The purpose of this trial is to find out whether personalising treatment by measuring a hormone called renin with a blood test can select people who will benefit from early treatment with a widely used blood pressure medication called spironolactone, an aldosterone blocker. We will do this by randomly assigning individuals with high blood pressure and low renin to either spironolactone or standard blood pressure lowering medications. Participants will be assessed every 12 weeks for 48 weeks. Medication doses will be slowly increased until blood pressure is controlled. At the end of the trial, we will compare individuals who received aldosterone blockers to standard blood pressure-lowering medications and see if there is a difference in blood pressure control and markers of heart and kidney health.
Interventions
Participants will be randomised to receive either mineralocorticoid receptor antagonists (MRA) or standard antihypertensive treatment for 48 weeks. Medications will be up-titrated 12-weekly until target blood pressure is reached (both treatment arms) and renin is un-suppressed (in the MRA treatment arm). Medications will be encapsulated and dispensed by the clinical trials pharmacy. Medication adherence will be monitored using a participant medication diary and pill counting of returned medicati
Participants will be randomised to receive either mineralocorticoid receptor antagonists (MRA) or standard antihypertensive treatment for 48 weeks. Medications will be up-titrated 12-weekly until target blood pressure is reached (both treatment arms) and renin is un-suppressed (in the MRA treatment arm). Medications will be encapsulated and dispensed by the clinical trials pharmacy. Medication adherence will be monitored using a participant medication diary and pill counting of returned medications. MRA titration schedule: 1. Commence on spironolactone 25mg tablet oral daily 2. Increase to spironolactone 50mg tablet oral daily 3. Increase to spironolactone 75mg tablet oral daily 4. Increase to spironolactone 100mg tablet oral daily
Sponsors
Dr Jun Yang
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults with hypertension, defined as a mean seated blood pressure > 140/90 mmHg, who are treatment naïve or are receiving up to two antihypertensive agents, and 2. Have a low plasma renin concentration defined as < 10 mU/L, and 3. Can provide informed consent.
Exclusion criteria
1. Blood pressure >180/120 mmHg 2. On medications confounding plasma renin concentration or plasma aldosterone concentration such as glucocorticoids, oestrogen-containing oral contraceptive pill and hormone replacement therapy and sodium-glucose co-transporter 2 inhibitors 3. Pregnant, breastfeeding or women of child-bearing potential 4. Uncontrolled diabetes with a glycosylated haemoglobin (HbA1C) > 7.5% 5. Chronic kidney disease with an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 6. Heart failure class II-IV, ischaemic heart disease, transient ischaemic attack, stroke or atrial fibrillation 7. Liquorice abuse 8. Known secondary cause of hypertension (primary hyperparathyroidism, PA defined as PAC post-SST>162 pmol/L where PAC was measured by liquid chromatography-tandem mass spectrometry or > 170 pmol/L where PAC was only measured by radioimmunoassay, autonomous cortisol secretion, hyperthyroidism, phaeochromocytoma, renal artery stenosis or known monogenic causes of low-renin hypertension 9. Hypersensitivity to the trial medications. 10. Potassium > 5.0mmol/L
Outcome results
None listed