Resistant HypertensionNCT06880562
The RESPLASH Study
A study testing Splanchnic Nerve Denervation and Renal Denervation Only in people with Resistant Hypertension, run by Tulane University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Splanchnic Nerve Denervation and Renal Denervation Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- History of previous renal artery CDN.
- Pregnancy or planned pregnancy during the study period.
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
East Jefferson General Hospital
New Orleans, Louisiana, 70006
Chris Wang, MS, 504-988-3065, hwang37@tulane.edu
Suzanne Bowers, RN, BSN, 504-988-2030, sbowers@tulane.edu
About this study
Official title: Renal and Splanchnic Sympathetic Denervation as an Alternative Therapy for Resistant Hypertension and Type 2 Diabetes (RESPLASH Study)
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.
Read the 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 undergo renal artery denervation with subsequent splanchnic nerves denervation for lowering blood pressure and glycemic levels.
20 patients will be randomly selected from outpatient cardiology clinics and will be assigned (1:1) to receive an FDA approved catheter-based denervation (CDN) of the renal arteries or CDN of the renal arteries with subsequent CDN of the splanchnic nerves at the level of the celiac artery and SMA. All patients will receive non-selective renal and mesenteric artery angiography prior and post CDN. All patients will undergo office systolic and diastolic blood pressure measurements, glycemic indices (HbA1c, fasting plasma insulin, C-peptide), and other laboratory assessments (plasma norepinephrine, renin, aldosterone, angiotensin II, lipids, and liver biochemistry) at baseline and outpatient follow-up visits (months 1, 3 and 6 post procedure).
- Conditions
- Resistant Hypertension
- Being tested
- Splanchnic Nerve Denervation, Renal Denervation Only
- Keywords
- Renal Sympathetic Denervation, Splanchnic Sympathetic Denervation, Hypertension, Diabetes mellitus, Catheter-based radiofrequency ablation, Lowering blood pressure, Control of glycemic levels
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splanchnic Nerve DenervationDevice
Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation
Renal Denervation OnlyDevice
Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation
| Study group | Role | What they receive |
|---|---|---|
| CDN of Renal arteries Arm | Placebo comparator | Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation Receives: Device: Renal Denervation Only |
| CND of Renal Arteries and Splanchnic Nerves Arm | Experimental | Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation Receives: Device: Splanchnic Nerve Denervation; Device: Renal Denervation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months
Secondary outcomes (1)
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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Wiley, MD, MPH, FACC, FACP, FSCAI, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880562
- Sponsor's protocol ID
- 2024-1510
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal and Splanchnic Sympathetic Denervation as an Alternative Therapy for Resistant Hypertension and Type 2 Diabetes (RESPLASH Study)
- ClinicalTrials.gov ID
- NCT06880562
- Acronym / sponsor ID
- 2024-1510
- Conditions
- Resistant Hypertension
- Keywords
- Renal Sympathetic Denervation, Splanchnic Sympathetic Denervation, Hypertension, Diabetes mellitus, Catheter-based radiofrequency ablation, Lowering blood pressure, Control of glycemic levels
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 undergo renal artery denervation with subsequent splanchnic nerves denervation for lowering blood pressure and glycemic levels.
20 patients will be randomly selected from outpatient cardiology clinics and will be assigned (1:1) to receive an FDA approved catheter-based denervation (CDN) of the renal arteries or CDN of the renal arteries with subsequent CDN of the splanchnic nerves at the level of the celiac artery and SMA. All patients will receive non-selective renal and mesenteric artery angiography prior and post CDN. All patients will undergo office systolic and diastolic blood pressure measurements, glycemic indices (HbA1c, fasting plasma insulin, C-peptide), and other laboratory assessments (plasma norepinephrine, renin, aldosterone, angiotensin II, lipids, and liver biochemistry) at baseline and outpatient follow-up visits (months 1, 3 and 6 post procedure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDN of Renal arteries Arm | Placebo comparator | Device: Renal Denervation OnlyCatheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation |
| CND of Renal Arteries and Splanchnic Nerves Arm | Experimental | Device: Splanchnic Nerve Denervation, Device: Renal Denervation OnlyCatheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splanchnic Nerve DenervationCatheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation | Device | CND of Renal Arteries and Splanchnic Nerves Arm |
| Renal Denervation OnlyCatheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation | Device | CDN of Renal arteries Arm, CND of Renal Arteries and Splanchnic Nerves Arm |
Primary outcome
Change in office systolic and diastolic blood pressure
Time frame: Baseline, 3 months
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.
1 secondary outcome
Change in HbA1C
Time frame: Baseline, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Wiley, MD, MPH, FACC, FACP, FSCAI principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splanchnic Nerve Denervation and Renal Denervation Only in people with Resistant Hypertension, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Wang, MS (504-988-3065, hwang37@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in office systolic and diastolic blood pressure (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.