A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Change in autonomic dysfunction symptoms
研究概览
简要总结
This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients (age 12 to years and older) with chronic (>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations.
- •Symptomatic orthostatic heart rate increment ≥30 bpm if >19 years old or ≥40 bpm if <19 years old during a 10 minute 70 degree head up tilt study
- •Presence of non-anemic iron deficiency, defined as serum ferritin levels <20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender
- •Consent obtained from responsible guardian AND from subjects, 12-17 years of age
- •Consent obtained for subjects 18 years of age and older
排除标准
- •Orthostatic hypotension (decrease of systolic BP>30 mmHg and/or diastolic BP>15mmHg within 3 minutes of 70 degree head up tilt study)
- •Pregnant or lactating females
- •The presence of failure of other organ systems or systemic illness that can affect autonomic function
- •Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study
- •Laboratory evidence of anemia or iron overload
- •Personal history of hematochromatosis or first degree relative with hematochromatosis
- •Known sensitivity to Venofer® (iron sucrose injection, USP) or other intravenous iron preparation
研究组 & 干预措施
Iron Sucrose Group
Subjects will receive intravenous iron sucrose during a tilt table test
干预措施: Sucrose (Drug)
Iron Sucrose Group
Subjects will receive intravenous iron sucrose during a tilt table test
干预措施: Tilt Table Test (Diagnostic Test)
Placebo Group
Subjects will receive intravenous placebo during a tilt table test
干预措施: Placebo (Drug)
Placebo Group
Subjects will receive intravenous placebo during a tilt table test
干预措施: Tilt Table Test (Diagnostic Test)
结局指标
主要结局
Change in autonomic dysfunction symptoms
时间窗: Baseline, 7 days, 6 months
Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction
Change in postural heart rate increase
时间窗: Baseline, 7 days
Heart rate change during tilt table test measured in beats per minute
次要结局
未报告次要终点
研究者
Kamal Shouman
Principal Investigator
Mayo Clinic