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治験 NCT04439370（対象：高血圧、早発閉経、更年期、血圧）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ミネソタ大学Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04439370 は 観察研究 臨床試験 で、高血圧、早発閉経、更年期、血圧 に関するものです。現在は 募集中 で、2019年10月1日 から開始しています。160 名の参加者 の募集が計画されています。この治験は ミネソタ大学 によって主催され、2025年12月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年7月24日 です。
概要
This is a cross-sectional study in which the investigators will determine the impact of premature/early menopause on MSNA, BP and baroreflex sensitivity in younger (≤49 yr old) and older (≥50 yr old) women. Specifically, aim one will determine mechanisms driving autonomic dysregulation of BP in premature and early menopausal women and aim two will determine mechanisms driving autonomic dysregulation of BP in older menopausal women. The study design outlined below will permit testing of aim one and aim two.
詳細説明
Aim One: Determine mechanisms driving autonomic dysregulation of blood pressure (BP) in premature and early menopausal women. Because sympathetic activity and baroreflex function are important contributors for autonomic support of BP regulation, these two mechanisms will be assessed in premature and early menopausal women who are ≤49 yr old. To specifically identify the influence of menopause, these women will be compared to age-matched premenopausal women. The primary hypothesis is that there is greater resting sympathetic activity and blunted baroreflex function in premature and early menopausal women compared with age-matched premenopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early menopausal compared with age-matched premenopausal women when the sympathetic nervous system is challenged with a stressor.
Aim Two: Determine mechanisms driving autonomic dysregulation of BP in older menopausal women. Because older age contributes to risk of CVD, it is imperative to assess the long-term effects of premature and early menopause in older (≥50 yr) women. To determine the impact of the premature loss of sex hormones on cardiovascular physiology, women whom have lived without functioning ovaries for >10 yr will be compared to age-matched women who entered menopause at a typical age. The primary hypothesis is that resting sympathetic activity is greater and baroreflex function is attenuated in women who experience premature or early menopause compared with typically-aged menopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early compared with typically-aged menopausal women when the sympathetic nervous system is challenged with a stressor.
公式タイトル
Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
疾患／病気
高血圧早発閉経更年期血圧その他の研究識別子
- PT-2018-27097
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Aim 1: Postmenopausal Women Participants in this group are postmenopausal women. | Microneurography to Measure Muscle Sympathetic Nerve Activity (MSNA) Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves Baroreflex Sensitivity Testing Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers. Sympathoexcitatory Maneuvers Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed 血液検査 Serum FSH, estrogen, progesterone, and testosterone will be measured |
Aim 1: Premenopausal Women Participants in this group are premenopausal women. | Microneurography to Measure Muscle Sympathetic Nerve Activity (MSNA) Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves Baroreflex Sensitivity Testing Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers. Sympathoexcitatory Maneuvers Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed 血液検査 Serum FSH, estrogen, progesterone, and testosterone will be measured |
Aim 2: Premature/Early Menopause Participants in this group women who experienced premature or early menopause. | Microneurography to Measure Muscle Sympathetic Nerve Activity (MSNA) Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves Baroreflex Sensitivity Testing Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers. Sympathoexcitatory Maneuvers Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed 血液検査 Serum FSH, estrogen, progesterone, and testosterone will be measured |
Aim 2: Typical-Age Menopause Participants in this group are women who experienced menopause at a typical age. | Microneurography to Measure Muscle Sympathetic Nerve Activity (MSNA) Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves Baroreflex Sensitivity Testing Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers. Sympathoexcitatory Maneuvers Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed 血液検査 Serum FSH, estrogen, progesterone, and testosterone will be measured |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Muscle Sympathetic Nerve Activity (MSNA) (bursts per minute) | Muscle sympathetic nerve activity (MSNA) is a measurement of sympathetic activity. This is measured by two small needles are inserted behind or on the side of the knee, one needle is an acupuncture needle and one needle is a small recording microelectrode (same size as the acupuncture needle). Outcome will be reported in units of bursts per minute. | 3 hours |
Muscle Sympathetic Nerve Activity (MSNA) (bursts/100 heart beats) | Muscle sympathetic nerve activity (MSNA) is a measurement of sympathetic activity. This is measured by two small needles are inserted behind or on the side of the knee, one needle is an acupuncture needle and one needle is a small recording microelectrode (same size as the acupuncture needle). Outcome will be reported in units of bursts per 100 heart beats. | 3 hours |
Cardiac baroreflex sensitivity | Baroreflex sensitivity will be derived from electrocardiogram measurements and blood pressure measurements during the baseline rest period and by performing a modified valsalva maneuver which involves exhaling against 30-40 mmHg of pressure over 15 seconds after a normal inhalation. Outcome will be reported in units as ms/mmHg. | 3 hours |
Sympathetic baroreflex sensitivity | Baroreflex sensitivity will be derived from electrocardiogram measurements and blood pressure measurements during the baseline rest period and by performing a modified valsalva maneuver which involves exhaling against 30-40 mmHg of pressure over 15 seconds after a normal inhalation. Outcome will be reported in units of MSNA bursts/mmHg. | 3 hours |
Systolic Blood Pressure (mmHg) | Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg. | 3 hours |
Diastolic Blood Pressure (mmHg) | Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg. | 3 hours |
Mean Arterial Blood Pressure (mmHg) | Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg. | 3 hours |
Heart Rate (beats/min) | Heart rate will be measured with a three-lead electrocardiogram (ECG) and reported in units of beats/min. | 3 hours |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Respiratory Rate (breaths/min) | Respiratory rate will be measured with a belt placed around the stomach and reported in units of breaths-per-minute. | 3 hours |
Heart Rate Variability (frequency) | Heart rate variability will be measured using electrocardiogram and reported in units of Hertz. | 3 hours |
Heart Rate Variability (time) | Heart rate variability will be measured using electrocardiogram and reported in units of milliseconds. | 3 hours |
Borg Rating of Perceived Exertion | Participants will be asked to rate their perceived exertion using the Borg Rating of Perceived Exertion scale. Scores range from 6-20 with higher scores indicating greater exertion. | 3 hours |
Numerical Pain Scale Rating | Participants will be asked to rate pain on a scale from 0 to 10. Higher scores indicate greater pain. | 3 hours |
Blood Levels: Estrogens-E1 | Serum concentration of estrogen-E1 will be reported in units of ng/ml. | 75 minutes |
Blood Levels: Estrogen-E2 | Serum concentration of estrogen-E2 will be reported in units of ng/ml. | 75 minutes |
Blood Levels: Progesterone | Serum concentration of progesterone will be reported in units of ng/ml. | 75 minutes |
Blood Levels: Testosterone | Serum concentration of testosterone will be reported in units of ng/ml. | 75 minutes |
Blood Levels: Follicle-Stimulating Hormone (FSH) | Serum concentration of FSH will be reported in units of IU/L. | 75 minutes |
Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) | This test involves holding a hand grip device at 30% of the participant's maximum hand grip strength until they fatigue. At the end of this test a blood pressure cuff is inflated for two minutes. The outcome measurements are the total change in systolic, diastolic and mean blood pressure from rest as well as how much blood pressure changes every 15 seconds. The measurement units are the change in blood pressure in mmHg. | 3 hours |
Cold Pressor Test | The cold pressor test is done by placing the participant's hand in a bucket of ice-cold water for 2 minutes. The outcome measurements are the total change in systolic, diastolic and mean blood pressure from rest as well as how much blood pressure changes every 15 seconds. The measurement units are the change in blood pressure in mmHg. | 3 hours |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
35 Years
対象性別
女性
健康なボランティアを受け入れる
はい
- Aged 35-49 or 50-70 years of age who experienced premature (<40) or early (≤45) menopause
- Premenopausal 35-49 years of age
- Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old
- Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of >30 mIU/mL
- Current nicotine/tobacco use within the past six months
- Are diabetic or asthmatic
- Have diagnosed significant carotid stenosis
- Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury.
- Have existing metabolic or endocrine abnormities
- Take any heart/blood pressure medications that are determined to interfere with study outcomes
- IF the participant is premenopausal AND currently taking OC or other exogenous steroids that are determined to interfere with study outcomes
- Females who classify as having early or premature menopause AND are not willing to discontinue OC or MHT in order to complete the study
- Are pregnant or breastfeeding
ミネソタ大学413 件のアクティブな治験を探索試験中央連絡先
連絡先: Manda Keller-Ross, PhD, DPT, PT, 612-625-3175, [email protected]
1 1カ国の場所
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55455, United States
Manda Keller-Ross, PhD, DPT, PT, 連絡先, 612-625-3175, [email protected]
募集中