Vasomotor SymptomsNCT02202707
Vasomotor Symptoms and Cardiovascular Control
A study testing Gabapentin in people with Vasomotor Symptoms and Cardiovascular Health, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms, Cardiovascular Health
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 28Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138
About this study
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.
Read the detailed description
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.
Visit 4: Laboratory Testing Visit \& Medication Distribution All studies will be performed between ~8-10 am and will occur at the same time for the second laboratory testing visit. All subjects will be instructed to abstain from vigorous exercise for 2 days prior to each study to avoid autonomic and neuroendocrine effects of exercise. In addition, subjects will refrain from caffeine and alcohol for the previous 24 hrs, and be studied after a 12 hr fast.
- Study Visit: Parameters to be Measured
- Electrocardiogram.
- Arterial Pressure.
- Respiration.
- Sympathetic Microneurography.
- Beat-by-Beat Leg Blood Flow. B. Drugs to Study Human Physiology
- Intravenous bolus injection of 100 ug nitroprusside bolus (a vasodilator which drops pressure) 2) Intravenous bolus injection 150 ug phenylephrine bolus (a vasoconstrictor which raises pressure).
These two drugs are used to drop and raise pressure through a range of arterial pressures within a very short time, approximately 2 minutes.
These medications raise and lower blood pressure by the same amount typically experienced during the day when performing activities such as climbing stairs or moving from sitting to standing.
- Data to be collected/Timing of collection The study visit will take about 4 hours. Throughout the protocol, subjects will lie supine and will be instrumented for measurement of the ECG, beat-by-beat arterial pressure, brachial arterial pressure, respiratory excursions, and popliteal blood flow velocity. After instrumentation and calibration, instrumentation for measurement of peroneal nerve muscle sympathetic activity will commence, with the internal search lasting a maximum of 60 minutes.
After either successful or unsuccessful procurement of the nerve recording, the testing protocol will start:
Testing Protocol
- Baseline recordings/measurement (~10 minutes): Subjects will rest quietly for 10 minutes.
- Modified Oxford Baroreflex tests (5 minutes/trial, 2 trials, ~30 minutes total): An intravenous bolus injection of 100 ug nitroprusside bolus, followed in 1 minute by a 150 ug phenylephrine bolus. After the first trial, a second modified Oxford baroreflex test will be performed. At least 10-15 minutes will be allowed between the baroreflex trials to insure that heart rate, blood pressure and nerve activity return to resting levels. Subjects will be continually assessed for adverse events and symptoms related to hypotension.
- Sustained isometric handgrip exercise (~10 minutes): Subjects will be asked to perform an isometric handgrip exercise at 30% of maximum effort sustained to fatigue.
- Valsalva's maneuver (~5 minutes): Subjects will be asked to blow into a tube via a mouthpiece and generate a pressure of ~40 mmHg sustained for 12 seconds. Data will be collected for one minute prior to the maneuver, one minute after, with two minutes of recovery between trials. This will be repeated to obtain three successful trials.
- Paced breathing (~15 minutes total): Subjects will be asked to maintain a constant breathing frequency of 15 breaths/min (0.25 Hz) following an audio signal (i.e., "in, two, out, two") for 5 minutes after a short period of acclimation.
Distribution of Study Medication: After all baseline measures are complete, study medication (gabapentin) will be distributed to all study participants and participants will be instructed as to how to take and titrate the medication dose.
Visit 5a: Medication Dosage \& Adverse Event Monitoring (Telephone) Study staff will check in with study participants over the telephone after they have been on gabapentin for approximately one week to monitor any side effects or adverse events of the medication. If subjects are experiencing intolerable side effects, they will be taken off of the medication while completing the remaining study procedures. In order to track potential after effects of microneurography, subjects who had the electrode placed beneath the surface of their skin will be given the Microneurography Questionnaire (MSNA). Over the last 18 years of performing the technique, roughly 5% of participants have after effects, and of these the most often reported effect (>90%) is slight bruising at the site of insertion.
Visit 5b: Medication Dosage \& Adverse Event Monitoring (Telephone) Study staff will check in with study participants over the telephone after they have been on gabapentin for approximately three weeks to monitor any side effects or adverse events of the medication. If subjects are experiencing intolerable side effects, they will be taken off of the medication while completing the remaining study procedures.
Visit 6: Objective VMS Monitoring All subjects will repeat the 6-hour laboratory objective VMS monitoring session on gabapentin for post-treatment measures of VMS, as described above for Visit 3. Participants will also complete the same set of pre-treatment questionnaires about their VMS, related quality-of-life symptoms (sleep, mood) and quality-of-life. All subjects will be given the ambulatory VMS monitor to wear for 24 hours at home, to capture the frequency of VMS in the ambulatory setting as well as the actigraphic watch to wear for a one-week period. Participants will be reminded to continue to complete their VMS and sleep diaries.
Visit 7: Laboratory Testing Visit \& Medication Collection Procedures performed during Visit 4 will be repeated at Visit 7, to collect data on cardiovascular measures after participants have been on gabapentin for at least 4 weeks at the full dose. All VMS and sleep diaries, as well as unused study medication, actigraphic watch, and the objective VMS monitor, will be returned and collected at this visit.
- Conditions
- Vasomotor Symptoms, Cardiovascular Health
- Being tested
- Gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
Study medication, gabapentin, will be distributed to all study participants and participants will be instructed as to how to take and titrate the medication dose. Participants will take gabapentin daily for up to six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Other | Open label single arm study. All participants will receive Gabapentin. Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in cardiovagal tone with treatment of vasomotor symptoms in women
Cardiovagal tone will be assessed using heart rate and blood pressure at rest and in response to pharmacological and physical tasks
Measured: 5 weeks
Alterations in sympathetic efferent outflow with treatment of vasomotor symptoms
muscle sympathetic nerve activity at rest and in response to pharmacological and physical tasks
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: No funding obtained to conduct study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Spaulding Rehabilitation Hospital
- Responsible party
- Principal investigator, Suzanne Bertisch, Beth Israel Deaconess Medical Center
- Investigators
- J. Andrew Taylor, PhD, Principal investigator, Spaulding Hospital Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202707
- Sponsor's protocol ID
- 2013P002024
- Status last verified
- Aug 2015
- First submitted
- 22 Jul 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasomotor Symptoms and Cardiovascular Control
- ClinicalTrials.gov ID
- NCT02202707
- Acronym / sponsor ID
- 2013P002024
- Conditions
- Vasomotor Symptoms, Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding obtained to conduct study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Spaulding Rehabilitation Hospital
- Study start
- May 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Visit 4: Laboratory Testing Visit \& Medication Distribution All studies will be performed between ~8-10 am and will occur at the same time for the second laboratory testing visit. All subjects will be instructed to abstain from vigorous exercise for 2 days prior to each study to avoid autonomic and neuroendocrine effects of exercise. In addition, subjects will refrain from caffeine and alcohol for the previous 24 hrs, and be studied after a 12 hr fast.
- Study Visit: Parameters to be Measured
- Electrocardiogram.
- Arterial Pressure.
- Respiration.
- Sympathetic Microneurography.
- Beat-by-Beat Leg Blood Flow. B. Drugs to Study Human Physiology
- Intravenous bolus injection of 100 ug nitroprusside bolus (a vasodilator which drops pressure) 2) Intravenous bolus injection 150 ug phenylephrine bolus (a vasoconstrictor which raises pressure).
These two drugs are used to drop and raise pressure through a range of arterial pressures within a very short time, approximately 2 minutes.
These medications raise and lower blood pressure by the same amount typically experienced during the day when performing activities such as climbing stairs or moving from sitting to standing.
- Data to be collected/Timing of collection The study visit will take about 4 hours. Throughout the protocol, subjects will lie supine and will be instrumented for measurement of the ECG, beat-by-beat arterial pressure, brachial arterial pressure, respiratory excursions, and popliteal blood flow velocity. After instrumentation and calibration, instrumentation for measurement of peroneal nerve muscle sympathetic activity will commence, with the internal search lasting a maximum of 60 minutes.
After either successful or unsuccessful procurement of the nerve recording, the testing protocol will start:
Testing Protocol
- Baseline recordings/measurement (~10 minutes): Subjects will rest quietly for 10 minutes.
- Modified Oxford Baroreflex tests (5 minutes/trial, 2 trials, ~30 minutes total): An intravenous bolus injection of 100 ug nitroprusside bolus, followed in 1 minute by a 150 ug phenylephrine bolus. After the first trial, a second modified Oxford baroreflex test will be performed. At least 10-15 minutes will be allowed between the baroreflex trials to insure that heart rate, blood pressure and nerve activity return to resting levels. Subjects will be continually assessed for adverse events and symptoms related to hypotension.
- Sustained isometric handgrip exercise (~10 minutes): Subjects will be asked to perform an isometric handgrip exercise at 30% of maximum effort sustained to fatigue.
- Valsalva's maneuver (~5 minutes): Subjects will be asked to blow into a tube via a mouthpiece and generate a pressure of ~40 mmHg sustained for 12 seconds. Data will be collected for one minute prior to the maneuver, one minute after, with two minutes of recovery between trials. This will be repeated to obtain three successful trials.
- Paced breathing (~15 minutes total): Subjects will be asked to maintain a constant breathing frequency of 15 breaths/min (0.25 Hz) following an audio signal (i.e., "in, two, out, two") for 5 minutes after a short period of acclimation.
Distribution of Study Medication: After all baseline measures are complete, study medication (gabapentin) will be distributed to all study participants and participants will be instructed as to how to take and titrate the medication dose.
Visit 5a: Medication Dosage \& Adverse Event Monitoring (Telephone) Study staff will check in with study participants over the telephone after they have been on gabapentin for approximately one week to monitor any side effects or adverse events of the medication. If subjects are experiencing intolerable side effects, they will be taken off of the medication while completing the remaining study procedures. In order to track potential after effects of microneurography, subjects who had the electrode placed beneath the surface of their skin will be given the Microneurography Questionnaire (MSNA). Over the last 18 years of performing the technique, roughly 5% of participants have after effects, and of these the most often reported effect (>90%) is slight bruising at the site of insertion.
Visit 5b: Medication Dosage \& Adverse Event Monitoring (Telephone) Study staff will check in with study participants over the telephone after they have been on gabapentin for approximately three weeks to monitor any side effects or adverse events of the medication. If subjects are experiencing intolerable side effects, they will be taken off of the medication while completing the remaining study procedures.
Visit 6: Objective VMS Monitoring All subjects will repeat the 6-hour laboratory objective VMS monitoring session on gabapentin for post-treatment measures of VMS, as described above for Visit 3. Participants will also complete the same set of pre-treatment questionnaires about their VMS, related quality-of-life symptoms (sleep, mood) and quality-of-life. All subjects will be given the ambulatory VMS monitor to wear for 24 hours at home, to capture the frequency of VMS in the ambulatory setting as well as the actigraphic watch to wear for a one-week period. Participants will be reminded to continue to complete their VMS and sleep diaries.
Visit 7: Laboratory Testing Visit \& Medication Collection Procedures performed during Visit 4 will be repeated at Visit 7, to collect data on cardiovascular measures after participants have been on gabapentin for at least 4 weeks at the full dose. All VMS and sleep diaries, as well as unused study medication, actigraphic watch, and the objective VMS monitor, will be returned and collected at this visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Other | Drug: GabapentinOpen label single arm study. All participants will receive Gabapentin. |
Who may qualify
- Ages
- 45 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
- Normal to overweight (18.5≤BMI≤35 kg/m2)
- Sedentary to normally physically active (performing regular aerobic exercise <60 min/week)
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: NeurontinStudy medication, gabapentin, will be distributed to all study participants and participants will be instructed as to how to take and titrate the medication dose. Participants will take gabapentin daily for up to six weeks. | Drug | Gabapentin |
Primary outcome
Alterations in cardiovagal tone with treatment of vasomotor symptoms in women
Time frame: 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
Time frame: 5 weeks
muscle sympathetic nerve activity at rest and in response to pharmacological and physical tasks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Andrew Taylor, PhD principal investigator
Spaulding Hospital Cambridge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin in people with Vasomotor Symptoms and Cardiovascular Health, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in cardiovagal tone with treatment of vasomotor symptoms in women (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.