Evaluating renal denervation for treating isolated diastolic hypertension
Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension: the STOP Study a Multicenter, Randomized, Sham-controlled Trial
This study is testing if a new treatment called renal denervation can help people with isolated diastolic hypertension lower their blood pressure safely.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Shanghai 10th People's Hospital Academic / other |
| Locations | 2 sites (Shanghai, Shanghai and 1 other locations) |
| Trial ID | NCT06783296 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the efficacy and safety of renal denervation (RDN) in patients diagnosed with isolated diastolic hypertension (IDH). It is a randomized, sham-controlled, multicenter trial involving 44 participants, with 33 receiving the RDN treatment and 11 in a sham control group. The study will monitor changes in blood pressure and any adverse events over a 6-month follow-up period, aiming to provide new insights into RDN as a potential treatment for IDH.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 with isolated diastolic hypertension and no antihypertensive medication.
Not a fit: Patients with secondary hypertension, significant comorbidities, or those with a history of cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from isolated diastolic hypertension.
How similar studies have performed: While this approach is being explored, the specific application of renal denervation for isolated diastolic hypertension is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - 1. Age 18-45 years. 2. Diagnosed with isolated diastolic hypertension (office SBP \< 140 mmHg and DBP ≥ 90 mmHg without antihypertensive medication). 3. Signed informed consent. Exclusion Criteria: * 1. Office DBP ≥ 110 mmHg. 2. Secondary hypertension or arrhythmias affecting blood pressure accuracy (e.g., atrial fibrillation). 3. Comorbidities such as diabetes, chronic kidney disease (eGFR \< 30 mL/min/1.73m²), coronary artery disease, or heart failure. 4. History of stroke or myocardial infarction. 5. Known bleeding disorders or inability to tolerate anticoagulation. 6. Renal artery abnormalities or prior renal artery/coronary artery interventions. 7. Pregnancy, breastfeeding, or planning to become pregnant. 8. Life expectancy \< 1 year. 9. Participation in another clinical trial.
Where this trial is running
Shanghai, Shanghai and 1 other locations
- Department of Cardiology, Shanghai Tenth People's Hospital — Shanghai, Shanghai, China (Recruiting)
- Shanghai Tenth People's Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Yi Zhang
- Email: yizshcn@gmail.com
- Phone: 18917686332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.