NCT07831551Not yet recruiting
EECP for Erectile Dysfunction in Elderly Hypertensive Patients
Efficacy and Safety of Enhanced External Counterpulsation in Elderly Hypertensive Patients With Erectile Dysfunction: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 6 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 May 2027
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- High blood pressure
- NCT number
- NCT07831551
What you commit to
- Study type: Interventional
- Planned participants: 106
- From 1 Oct 2026 to the primary completion date, 1 May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of other medications that may significantly affect blood pressure, such as glucocorticoids.
- Participation in another clinical trial within the previous 3 months.
Other illness
- Uncontrolled hypertension (\>180/110 mmHg) or secondary hypertension.
- Diabetes mellitus.
- 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.
- A contraindication to enhanced external counterpulsation, including severe aortic regurgitation, aortic aneurysm, active thrombophlebitis, or lower-extremity deep vein thrombosis.
Lab values
- 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.
Other
- A clinically significant penile anatomical or structural abnormality as determined by the investigator, including micropenis, penile curvature, or fibrosis of the corpora cavernosa.
Who the study is looking for
- 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.
Age in the registry: 60 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Seventh Affiliated Hospital (Shenzhen), Sun Yat-sen University Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.