SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders (STOOD): a Phase IIa Randomised Controlled Trial of Sodium Supplementation in Those Consuming Moderate Salt Intake.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Recruitment to target (primary feasibility outcome)
研究概览
简要总结
Background
Orthostatic hypotension (OH) is a common cause of falls, and key source of morbidity and mortality due to injury (e.g. hip fracture). Current guidelines recommend increasing salt intake in patients with symptomatic orthostatic hypotension. However, the evidence underpinning this recommendation is poor, based primarily on small trials with very short-term follow-up (< 6 weeks).
Clinical Equipoise (Overall)
High salt intake might improve quality of life and reduce the risk of falls, but might also increase the risk of cardiovascular disease, in patients with OH.
Specific Objective of Current Application (Aim)
To determine feasibility (recruitment, retention and adherence) of conducting a randomized controlled trial evaluating high salt intake in older adults with symptomatic orthostatic hypotension.
To determine preliminary estimates of the effect of high salt intake on disease-specific quality of life, orthostatic blood pressure (BP) parameters, and cardiac blood biomarkers.
Design: Phase IIa, parallel, double-blind, randomised controlled, single centre clinical trial of 12 month follow-up duration.
Population: Older adults (≥65 years of age) with an objective diagnosis of symptomatic orthostatic hypotension
Intervention: The intervention will be 5g/day of salt supplementation in the form of encapsulated sodium chloride.
Outcome measures: Primary outcome (Feasibility) recruitment and retention rates, adherence with intervention and study protocol, completeness of follow-up. Secondary Outcome (Efficacy): i) clinical: change in Orthostatic Hypotension Questionnaire score, modification/addition of OH pharmacotherapy, and falls events, ii) physiological measures of orthostasis: change in difference between supine and nadir systolic BP, standing BP at 1 minute, 24 hour mean BP measured by 24 hour ambulatory BP monitor, iii) cardiovascular biomarkers.
Clinical Importance:
A recommendation for long-term increases in salt intake may have adverse cardiovascular consequences, which necessitates the identification of the optimal range of salt intake associated with greatest reduction in falls risk and lowest cardiovascular risk. Our study will provide preliminary evidence of treatment effect and assess feasibility, to inform a definitive trial.
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
盲法说明
This study is open-label. Blinding of participants is not possible for practical reasons. However, there is blinded assessment of change in formula derived 24-hour urinary sodium, cardiovascular biomarkers and mean 24-hour ambulatory blood pressure.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 65 years of age
- •Documented history of orthostatic hypotension, defined by decrease in systolic blood pressure (SBP) of ≥20 mmHg or a decrease in diastolic blood pressure (DBP) of ≥10 mmHg within three minutes of standing when compared with blood pressure from the supine position, or at head-up tilt testing.
- •A documented history of symptoms consistent with orthostatic hypotension including one of the following: light-headedness, dizziness, feeling faint, feeling like they may black out
- •Baseline salt intake expected to be in the moderate range (5-10g/day) based on screening questions
- •Willingness to supplement sodium intake
- •Ability to provide written informed consent
排除标准
- •Severe supine hypertension (Systolic blood pressure≥180mmHg or diastolic blood pressure >110mmHg) measured as average of three office readings
- •A diagnosis of Heart Failure (New York Heart Association (NYHA) Class III or IV symptoms or known left ventricular ejection fraction 30%, if more than one echo eligibility is defined by most recent echo)
- •CKD (eGFR <30ml/min/1.73m2) based on eGFR measured within the last 6 months
- •Participants taking loop diuretics
- •Serum sodium <125mmol at last measurement
- •Acute intercurrent illness
- •Prescribed high-salt diet (for clinical indication other than for OH) or low-salt diet for evidence based clinical indication
- •Participant unlikely to comply with study procedures or follow-up visits due to severe comorbid illness or other factor (e.g. inability to travel for follow-up visits) in opinion of research team
- •Inability to provide informed consent in the opinion of the investigator (for example due to severe cognitive impairment)
研究组 & 干预措施
Salt supplementation
Salt supplementation in the form of 1.25g sodium chloride capsules at a dose of 5g/day in two divided doses
干预措施: Salt supplementation (encapsulated sodium chloride) (Dietary Supplement)
Usual salt intake (no change in intake)
Usual salt intake (no change in intake)
结局指标
主要结局
Recruitment to target (primary feasibility outcome)
时间窗: 15 months
Recruitment of 48 participants
Change in orthostatic hypotension questionnaire score (primary efficacy outcome)
时间窗: 6 months
Change in symptoms and quality of life measured using disease specific questionnaire; Orthostatic Hypotension Questionnaire (OHQ) from baseline to final follow-up. All questionnaire items are scored 0 through 10 (higher scores = worse).
次要结局
- Falls events(6 months)
- Rates of modification/addition of OH pharmacotherapy(6 months)
- Rates of modification/addition of anti-hypertensive therapy(6 months)
- Change in difference between supine and nadir blood pressure from baseline to final in-person follow-up(6 months)
- Change in standing BP at one minute and three minutes(6 months)
- Change in mean BP measured by 24 hour ambulatory BP monitor(6 months)
- Change in formula derived 24 hour urinary sodium from baseline to final in-person follow-up visit.(6 months)
- Change in renin-aldosterone ratio from baseline to final in-person follow-up visit.(6 months)
- Change in individual components of OHQ from baseline to final follow-up(6 months)
- Change in cardiovascular biomarkers; proBNP and troponin(6 months)
研究者
Catriona Reddin
Research Fellow, Geriatric Medicine SpR
University of Galway