SPIRO-First: A Pragmatic Primary Care-Embedded Pilot Trial of Renin-Guided First-Line Antihypertensive Therapy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- PRIMARY OUTCOME: Recruitment Rate of Randomized Participants per Month
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Treating primary care clinician has independently determined that initiation of antihypertensive pharmacotherapy is clinically indicated.
- •Not currently receiving antihypertensive therapy, OR
- •Receiving a single antihypertensive medication (ACE inhibitor, ARB, thiazide/thiazide-like diuretic, or calcium channel blocker) which the treating primary care clinician considers safe to discontinue for a 2-week washout period.
- •Suppressed renin defined as direct renin concentration <6 ng/L (<10 mU/L) measured under routine outpatient conditions. Suppressed renin was selected as the primary biologic enrichment criterion because it is the physiologic hallmark of sodium-retaining, aldosterone-mediated hypertension and is more pragmatically scalable in primary care than complex biochemical primary aldosteronism (PA) definitions.
- •In the opinion of the treating primary care clinician, outpatient participation in the study is appropriate.
排除标准
- •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.
- •Known intolerance or contraindication to spironolactone, candesartan, hydrochlorothiazide, or amlodipine.
- •eGFR <30 mL/min/1.73 m
- •Serum potassium ≥5.0 mmol/L.
- •Serum sodium <135 mmol/L.
- •Pregnancy, breastfeeding, or intention to become pregnant during the study period. Women of childbearing potential must have a negative pregnancy test prior to randomization.
- •Participation in another interventional study likely to affect blood pressure.
- •Inability to provide consent
研究组 & 干预措施
Standard first-line antihypertensive therapy
Participants randomized to standard therapy will undergo secondary randomization to candesartan (8 mg daily), hydrochlorothiazide (25 mg daily), or amlodipine (5 mg daily)
干预措施: Hydrochlorothiazide (HCTZ) 25 milligrams. (Drug)
Spironolactone
Spironolactone 25 mg daily
干预措施: Spironolactone (drug) (Drug)
Standard first-line antihypertensive therapy
Participants randomized to standard therapy will undergo secondary randomization to candesartan (8 mg daily), hydrochlorothiazide (25 mg daily), or amlodipine (5 mg daily)
干预措施: Candesartan 8mg (Drug)
Standard first-line antihypertensive therapy
Participants randomized to standard therapy will undergo secondary randomization to candesartan (8 mg daily), hydrochlorothiazide (25 mg daily), or amlodipine (5 mg daily)
干预措施: Amlodipine (5mg) (Drug)
结局指标
主要结局
PRIMARY OUTCOME: Recruitment Rate of Randomized Participants per Month
时间窗: 12 months following activation of all participating study sites
Recruitment rate, defined as the average number of participants randomized per month during the recruitment period following activation of all participating study sites. Recruitment feasibility will be assessed by calculating the number of participants randomized each month over the 12-month recruitment period.
次要结局
- SECONDARY OUTCOME #1: Number of Potentially Eligible Participants Identified(12 months)
- SECONDARY OUTCOME #2: Eligibility Rate(12 months)
- SECONDARY OUTCOME #3: Recruitment Acceptance Rate(12 months)
- SECONDARY OUTCOME #4: Prevalence of Suppressed Renin Physiology(12 months)
- SECONDARY OUTCOME #5: Antihypertensive Washout Completion Rate(12 months)
- SECONDARY OUTCOME #6: Ambulatory Blood Pressure Monitoring Completion Rate(12 weeks)
- SECONDARY OUTCOME #7: Protocol Adherence Rate(12 weeks)
- SECONDARY OUTCOME #8: Study Completion Rate(12 weeks)
- SECONDARY OUTCOME #9: Reasons for Non-participation, Treatment Discontinuation, and Study Withdrawal(12 months)
- SECONDARY OUTCOME #10: Data Completeness(12 weeks)
- SECONDARY OUTCOME #11: Primary Care Clinician Satisfaction With Patient Participation(end of study (at 12 months))
- SECONDARY OUTCOME #12: Primary Care Clinician Satisfaction With Study Communication(end of study (at 12 months))
- SECONDARY OUTCOME #13: Primary Care Clinician Engagement(12 months)
研究者
Greg Hundemer
Clinician Scientist
Ottawa Hospital Research Institute