Status:
NOT_YET_RECRUITING
The RESPLASH Study
Lead Sponsor:
Tulane University
Conditions:
Resistant Hypertension
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 con...
Detailed Description
The investigators propose a multicenter, prospective, single blind, randomized controlled pilot study. Patients with treatment-resistant hypertension and diabetes mellitus type 2 will be enrolled to u...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06880562
Start Date
January 1 2026
End Date
January 1 2027
Last Update
November 18 2025
Active Locations (1)
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1
East Jefferson General Hospital
New Orleans, Louisiana, United States, 70006