The RESPLASH Study (NCT06880562) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The RESPLASH Study
United States20 participantsStarted 2026-06
Plain-language 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 control in patients with resistant hypertension and type 2 diabetes.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Change in office systolic and diastolic blood pressure