The RESPLASH Study
Starting soon · Not applicable
Conditions studied: Resistant Hypertension
In brief
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.
Key facts
- Study ID
- NCT06880562
- Run by
- Tulane University
- People needed
- 20
- Starts
- 2026-06-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Estimated glomerular filtration rate of less than 30 mL/min per 1.73m2.
- 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.
- Orthostatic hypotension.
- Acute or severe systemic infection.
- History of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 3 months.
- History of previous renal artery CDN.
- Pregnancy or planned pregnancy during the study period.
- Unable to provide informed consent.
Where it is running
- East Jefferson General Hospital — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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