The RESPLASH Study

Launched by TULANE UNIVERSITY · Mar 11, 2025

Keywords

ClinConnect Summary

The RESPLASH Study is a clinical trial designed to explore a new treatment for people who have resistant hypertension (high blood pressure that doesn't respond well to medication) and type 2 diabetes. Researchers want to see if a procedure called renal artery denervation, combined with another treatment that targets specific nerves, can help improve blood pressure and blood sugar levels in these patients. This study is still in the planning stages and hasn’t started enrolling participants yet.

To be eligible for this trial, participants need to be between 18 and 75 years old and have type 2 diabetes for at least five years. They should have high blood pressure that remains high even while taking three or more blood pressure medications. Additionally, their blood sugar levels must meet specific criteria. Participants will undergo a procedure that involves using a thin tube, or catheter, to deliver treatment to the kidneys and surrounding areas. It’s important to note that some individuals, such as those with certain kidney issues or recent heart problems, will not be able to participate. If you or a loved one fits this description and are interested in learning more, please reach out to the study team for further information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 18-75.
• • History of Type 2 Diabetes Mellitus at least 5 years prior to enrollment.
• • HbA1c level ≥6.5%. (is there an upper limits cutoff?)
• • 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.