SPIRO-First: A Pragmatic Primary Care-Embedded Pilot Trial of Renin-Guided First-Line Antihypertensive Therapy

ConditionHypertension
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

The goal of this clinical trial is to determine whether a renin-guided antihypertensive treatment strategy is feasible to implement in community primary care clinics and to explore whether spironolactone improves blood pressure control in adults with low-renin hypertension.

The main questions it aims to answer are:

Is it feasible to identify, recruit, randomize, and follow adults with low-renin hypertension in a pragmatic primary care-based clinical trial?

Does first-line treatment with spironolactone result in greater reductions in ambulatory blood pressure compared with standard first-line antihypertensive therapy among adults with low-renin hypertension?

Researchers will compare spironolactone 25 mg daily with standard first-line antihypertensive therapy (candesartan, hydrochlorothiazide, or amlodipine) to determine whether spironolactone provides better blood pressure control in adults with low-renin hypertension.

Participants will:

Undergo blood pressure assessments, blood tests, and ambulatory blood pressure monitoring (ABPM) to determine eligibility.

Be randomly assigned to receive either spironolactone or a standard first-line antihypertensive medication for 12 weeks.

Complete follow-up visits and laboratory testing to monitor blood pressure response, kidney function, electrolyte levels, medication adherence, and side effects.

Undergo repeat blood pressure measurements and ABPM at the end of the study.

Eligibility criteria

Qualifiers

Age ≥18 years.

Under the care of a primary care clinician in Ontario.

Standardized office systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg.

Mean daytime baseline ABPM systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg.

Disqualifiers

Standardized office systolic blood pressure >170 mmHg if untreated OR >150 mmHg if receiving one antihypertensive medication.

Known diagnosis of PA requiring specialist-directed management.

Known secondary hypertension requiring disease-specific therapy.

Current use of MR antagonists.

Trial design

Treatments tested in this trial

  • Spironolactone (drug)
  • Candesartan 8mg
  • Hydrochlorothiazide (HCTZ) 25 milligrams.
  • Amlodipine (5mg)

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ottawa Hospital Research Institute

Lead sponsor

The Ottawa Hospital

Collaborator