NCT06880562Not yet recruiting
The RESPLASH Study
Renal and Splanchnic Sympathetic Denervation as an Alternative Therapy for Resistant Hypertension and Type 2 Diabetes (RESPLASH Study)
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
To assess the safety and effectiveness of renal artery denervation with subsequent splanchnic nerves denervation via catheter-based radiofrequency ablation in improving blood pressure and glycemic control in patients with resistant hypertension and type 2 diabetes.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- Dec 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Tulane University
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT06880562
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Dec 2026 to the primary completion date, Dec 2027
- 1 site 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
- History of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 3 months.
- History of previous renal artery CDN.
Other illness
- Type 1 diabetes mellitus.
- History of aortic pathologies such as aneurysm or dissection confirmed by immediate preprocedural angiography that would preclude the Endovascular Denervation (EDN) procedure.
- Acute or severe systemic infection.
Other
- Estimated glomerular filtration rate of less than 30 mL/min per 1.73m2.
- Orthostatic hypotension.
- Pregnancy or planned pregnancy during the study period.
- Unable to provide informed consent.
Who the study is looking for
- Patients aged 18-75.
- History of Type 2 Diabetes Mellitus at least 5 years prior to enrollment.
- HbA1c level ≥6.5%
- Use of at least 1 oral antidiabetic agent and no changes in the last 30 days.
- History of essential hypertension with systolic Blood pressure of 160 mmHg or more (≥150 mmHg in patient with Type 2 Diabetes Mellitus), despite compliance with three of more antihypertensive drugs.
- Stable drug regimen of at least 3 antihypertensive medications with no changes for 2 weeks before enrollment.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| East Jefferson General Hospital Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.