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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Splanchnic Nerve Denervation
Device
Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation
Renal Denervation Only
Device
Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: CDN of Renal arteries ArmPlacebo comparator 1 intervention

Group B: CND of Renal Arteries and Splanchnic Nerves ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Change in office systolic and diastolic blood pressure

To assess the change in office systolic and diastolic blood pressure measurements using blood pressure cuffs at baseline to 3 months after Catheter Based Denervation (CND) at 1 month and 3 month interval.

Time frame

Baseline, 3 months

Secondary outcomes

Change in HbA1C

To assess the change in HbA1C from baseline to 3 months after procedure and monitor the effects of renal artery denervation with subsequent splanchnic nerves denervation.

Time frame

Baseline, 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: