Vasomotor Symptoms and Cardiovascular Control
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Alterations in cardiovagal tone with treatment of vasomotor symptoms in women
研究概览
简要总结
The purpose of this study is to preliminarily determine whether the frequency and/or severity of vasomotor symptoms (VMS) at baseline, and then after symptom reduction with gabapentin, relates to various cardiovascular control measures.
详细描述
Visit 1: Screening & Acclimation Visit
The informed consent process for the study will be completed and a signed informed consent form will be obtained at Spaulding Hospital Cambridge. Subjects will be screened to ensure they meet preliminary eligibility criteria. All subjects will undergo a clinical interview to determine the presence of any medical disorders. The following study assessments will be completed:
- 12-lead EKG
- Resting blood pressure and heart rate
- Height and Weight
Visit 2: VMS Determination and At-Home Assessments Subjects will be interviewed about their mental health history, and will complete questionnaires about their VMS, related quality-of-life symptoms (sleep, mood) and quality-of-life. Blood will be drawn to confirm eligibility and to assess for diabetes and chronic kidney disease (see exclusion criteria). Subjects will be given a 7-day VMS Diary and a 7-day Sleep Diary at the end of this visit, to be completed at home during the following week. Participants will also be given an actigraphic watch to take home to wear for 7 days in order to capture sleep/wake patterns and activity levels for exploratory analyses. During the 7 days of at-home VMS and sleep monitoring, subjects will also wear a portable VMS monitor for 24 hours to measure objective VMS frequency.
Visit 3: Final Eligibility Determination & Lab VMS Monitoring Subjects will return the objective VMS monitor and the VMS and sleep diaries, and the results of their blood tests taken during the Visit 2 will be reviewed to ensure eligibility. Eligible subjects will participate in a 6-hour laboratory objective VMS monitoring session by wearing an objective VMS monitor while simultaneously subjectively monitoring VMS experienced with a written diary and an event marker. Objective VMS measures obtained during this visit will be the primary baseline measure of VMS for investigation. Those who have at least 2 objective VMS measured during the 6-hour monitoring period will be deemed eligible and referred for baseline studies and to start medication. Participants will be given additional VMS and sleep diaries to complete on a daily basis throughout the rest of the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 58 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 45 to 58 years,
- •Early postmenopausal, defined as a minimum of one year and up to 6 years from final menstrual period (FMP)
- •Vasomotor symptoms for at least 6 months
- •At least 4/day or 28/week by retrospective report and confirmed on prospective monitoring over 2-week period.
- •At least 2 VMS measured objectively on the VMS monitor during the 6-hour VMS laboratory monitoring session.
- •Normal to overweight (18.5≤BMI≤35 kg/m2)
- •Sedentary to normally physically active (performing regular aerobic exercise <60 min/week)
排除标准
- •Hypertension (resting pressures ≥140/90 mmHg)
- •Diabetes (verified by plasma hemoglobin A1C level ≥6.5)
- •Cardiovascular disease, including any stenotic valvular heart disease
- •Neurological disease
- •Current depression (per screening procedures)
- •Current or history of suicidal ideation or attempts (within 3 years prior to enrollment)
- •Lifetime history of bipolar disorder
- •Active cancer (non-melanoma skin cancer allowed)
- •Abnormal resting ECG
- •Recent weight change (>10 lb weight change in last 6 months)
- •Regular tobacco use/current smoking
- •Current use of anti-hypertensives or other medications that could influence any of the dependent variables
- •Current or previous use (past 2 months) of anti-anxiety, anti-depressant or antipsychotic medications
- •Current use of vasodilators
- •Current use of stimulants or stimulant-like medications
- •Current use of systemic hormone therapies/medications
- •Current use of non-hormonal treatments for VMS
- •Current use of gabapentin or medications contraindicated to be used in combination with gabapentin
- •Past intolerance or hypersensitivity to gabapentin
- •History of syncope or vasovagal/carotid sensitivity
- •History of sickle cell anemia
- •Abnormal kidney function: CrCl or GFR <60 ml/min (Cockcroft and Gault equation)
- •Ventricular tachycardia
- •Hyperthyroidism
- •Hypersensitivity to phenylephrine
- •Compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting
- •Congenital (Leber's) optic atrophy or tobacco amblyopia
- •Hypersensitivity to nitroprusside
研究组 & 干预措施
Gabapentin
Open label single arm study. All participants will receive Gabapentin.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Alterations in cardiovagal tone with treatment of vasomotor symptoms in women
时间窗: 5 weeks
Cardiovagal tone will be assessed using heart rate and blood pressure at rest and in response to pharmacological and physical tasks
Alterations in sympathetic efferent outflow with treatment of vasomotor symptoms
时间窗: 5 weeks
muscle sympathetic nerve activity at rest and in response to pharmacological and physical tasks
次要结局
未报告次要终点
研究者
Suzanne Bertisch
BIDMC Site Investigator
Beth Israel Deaconess Medical Center