Efficacy and Safety of Enhanced External Counterpulsation in Elderly Hypertensive Patients With Erectile Dysfunction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Change From Baseline in Mean Office Systolic Blood Pressure at the End of Treatment
研究概览
简要总结
Hypertension and erectile dysfunction are common health problems in older men and may share vascular dysfunction as an underlying mechanism. Enhanced external counterpulsation (EECP) is a noninvasive treatment in which inflatable cuffs placed around the legs and buttocks are inflated and deflated in synchronization with the heartbeat to improve blood flow.
The purpose of this randomized controlled trial is to determine whether EECP, when added to usual antihypertensive treatment, improves blood pressure and is safe in older men with both hypertension and erectile dysfunction. The study will also evaluate whether EECP improves erectile function and other measures related to vascular function, circulation, quality of life, sleep, and psychological well-being.
A total of 106 men aged 60 to 75 years will be enrolled at two study centers. Participants will be randomly assigned in a 1:1 ratio to receive either active EECP or sham EECP in addition to their usual antihypertensive treatment. Active EECP will be administered for 1 hour per session, once daily, for 35 sessions over 5 weeks. Sham EECP will be administered using the same device and treatment schedule but at a low cuff pressure that is not expected to produce effective counterpulsation. Participants will not know which treatment they receive.
The main study outcome is the change from baseline to the end of the treatment period in average office blood pressure, calculated from three consecutive blood pressure measurements obtained at the study visit. Additional assessments will include office blood pressure during follow-up, 24-hour ambulatory blood pressure monitoring, erectile function, vascular function, hemodynamic measures, quality of life, and adverse events.
Participants will be assessed at baseline, after 20 treatment sessions, at the end of treatment, and at 1, 3, and 6 months after treatment.
详细描述
This is a two-center, participant-masked, randomized, sham-controlled clinical trial designed to evaluate the efficacy and safety of enhanced external counterpulsation (EECP) in older men with hypertension and erectile dysfunction.
Hypertension and erectile dysfunction may share vascular endothelial dysfunction as an underlying pathophysiological mechanism. EECP is a noninvasive external counterpulsation treatment that may improve systemic blood flow, tissue perfusion, and vascular endothelial function. This study will primarily evaluate the effect of EECP on blood pressure and will also explore its effects on erectile function and vascular function.
A total of 106 male participants aged 60 to 75 years will be enrolled. Eligible participants must have hypertension and erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score of 21 or lower with a duration of at least 3 months.
Participants will be randomly assigned in a 1:1 ratio to the active EECP group or the sham EECP group. Stratified block randomization will be used, with study center as the stratification factor and a block size of 4. Participants will be masked to treatment assignment. Both groups will continue their usual antihypertensive treatment, and antihypertensive medication regimens will be kept stable whenever clinically feasible during the study.
Participants assigned to the active EECP group will receive electrocardiogram-triggered sequential cuff inflation at a pressure of 250 to 275 mmHg. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants aged 60 to 75 years with a stable sexual partner.
- •Diagnosis of hypertension, defined as one of the following: office blood pressure ≥140/90 mmHg measured on three separate days without antihypertensive treatment; mean home blood pressure ≥135/85 mmHg measured over 5 to 7 consecutive days; or 24-hour ambulatory blood pressure ≥130/80 mmHg, daytime blood pressure ≥135/85 mmHg, or nighttime blood pressure ≥120/70 mmHg. Participants with a previous diagnosis of hypertension who are currently receiving antihypertensive treatment remain eligible even if their current blood pressure is below these thresholds.
- •Diagnosis of erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score ≤21 with a duration of at least 3 months.
- •Stable lifestyle, a stable female sexual partner, and willingness to attempt sexual intercourse with that partner during the study.
- •No treatment with phosphodiesterase type 5 inhibitors, hormones, health supplements, or other treatments intended to improve erectile function, including traditional Chinese medicines, within 3 months before enrollment.
- •Voluntary participation and ability to read, understand, and provide written informed consent.
排除标准
- •Severe cardiac disease, including New York Heart Association class IV heart failure, left ventricular ejection fraction <30%, malignant arrhythmia, or other clinically significant cardiac conditions.
- •Uncontrolled hypertension (>180/110 mmHg) or secondary hypertension.
- •Diabetes mellitus.
- •Current use of other medications that may significantly affect blood pressure, such as glucocorticoids.
- •A condition associated with an increased risk of priapism, such as sickle cell anemia or leukemia.
- •Peptic ulcer disease, a bleeding disorder, visual abnormality, or hearing impairment.
- •Malignant tumor or another severe primary disease involving the heart, liver, kidneys, hematopoietic system, or another major organ or system.
- •Neurological or psychiatric disease that prevents cooperation with study procedures, or unwillingness to cooperate.
- •History of alcohol or drug abuse.
- •Participation in another clinical trial within the previous 3 months.
- •A contraindication to enhanced external counterpulsation, including severe aortic regurgitation, aortic aneurysm, active thrombophlebitis, or lower-extremity deep vein thrombosis.
- •A clinically significant penile anatomical or structural abnormality as determined by the investigator, including micropenis, penile curvature, or fibrosis of the corpora cavernosa.
研究组 & 干预措施
Active EECP
Participants will continue their usual antihypertensive treatment and receive active enhanced external counterpulsation (EECP). Active EECP will be delivered using an electrocardiogram-triggered EECP device with sequential cuff inflation at a pressure of 250 to 275 mmHg. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.
干预措施: Enhanced External Counterpulsation (Device)
Sham EECP
Participants will continue their usual antihypertensive treatment and receive sham enhanced external counterpulsation using the same device, cuff placement, procedures, and treatment schedule as the active intervention. The cuff pressure will be set at 70 mmHg, which is not expected to produce effective counterpulsation. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.
干预措施: Sham Enhanced External Counterpulsation (Device)
结局指标
主要结局
Change From Baseline in Mean Office Systolic Blood Pressure at the End of Treatment
时间窗: Baseline and Day 35 (end of the 5-week treatment period)
Office systolic blood pressure will be measured three consecutive times at the study visit according to the standardized blood pressure measurement procedure. The arithmetic mean of the three measurements will be used as the mean office systolic blood pressure. The outcome will be calculated as the mean office systolic blood pressure at the end of the 5-week treatment period minus the corresponding baseline value and will be reported in mmHg.
次要结局
- Change From Baseline in Mean Office Diastolic Blood Pressure at the End of Treatment(Baseline and Week 5 (end of the treatment period))
- Mean Within-Session Change in Supine Systolic Blood Pressure(At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment)
- Mean Within-Session Change in Supine Diastolic Blood Pressure(At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment)
- Mean Within-Session Change in Supine Heart Rate(At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment)
- Change From Baseline in Mean Office Systolic Blood Pressure at Follow-up Assessments(Baseline; Week 3 (after 20 treatment sessions); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Mean Office Diastolic Blood Pressure at Follow-up Assessments(Baseline; Week 3 (after 20 treatment sessions); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in 24-Hour Mean Systolic Blood Pressure(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in 24-Hour Mean Diastolic Blood Pressure(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in the 5-Item International Index of Erectile Function Total Score(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Percentage of Participants Answering Yes to Sexual Encounter Profile Question 2(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Percentage of Participants Answering Yes to Sexual Encounter Profile Question 3(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Percentage of Participants Answering Yes to the Global Assessment Question(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in the Self-Esteem and Relationship Questionnaire Score(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Erectile Hardness Score(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Serum Nitric Oxide Level(Baseline; Week 5 (end of the treatment period); and Month 3 after the end of treatment)
- Change From Baseline in Serum Vascular Endothelial Growth Factor Level(Baseline; Week 5 (end of the treatment period); and Month 3 after the end of treatment)
- Change From Baseline in Brachial Artery Flow-Mediated Dilation(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Reactive Hyperemia Index(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Penile Artery Resistance Index(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Penile Artery Peak Systolic Velocity(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Cardiac Index(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Cardiac Output(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Stroke Volume(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Stroke Volume Index(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Mean Arterial Pressure(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in SSVRI(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Left Ventricular Stroke Work Index(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Systemic Vascular Resistance Index(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Ejection Phase Contractility Index(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Inotropic State Index(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Systemic Vascular Resistance(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Total Vascular Resistance(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Mean Heart Rate(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Pulse Wave Velocity(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Hamilton Anxiety Rating Scale Total Score(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in [Full Name of Depression Scale] Total Score(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Pittsburgh Sleep Quality Index Global Score(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in 36-Item Short Form Health Survey Domain Scores(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in the Standard Deviation of Normal-to-Normal Intervals(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in the Root Mean Square of Successive Normal-to-Normal Interval Differences(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in the Percentage of Successive Normal-to-Normal Intervals Differing by More Than 50 Milliseconds(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Low-Frequency Power(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in High-Frequency Power(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Very-Low-Frequency Power(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in Total Heart Rate Variability Power(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Change From Baseline in the Number of Nocturia Episodes per Night(Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment)
- Number of Participants With Adverse Events(From informed consent through Month 6 after the end of treatment)