The RESPLASH Study
ConditionResistant Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTulane University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Splanchnic Nerve Denervation
- Renal Denervation Only
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov