NCT06880562

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

March 11, 2025

Last Update Submit

February 27, 2026

Conditions

Resistant Hypertension

Keywords

Renal Sympathetic DenervationSplanchnic Sympathetic DenervationHypertensionDiabetes mellitusCatheter-based radiofrequency ablationLowering blood pressureControl of glycemic levels

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 3 months

Secondary Outcomes (1)

  • Change in HbA1C

    Baseline, 3 months

Study Arms (2)

CDN of Renal arteries Arm

PLACEBO COMPARATOR

Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation

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

Device: Splanchnic Nerve DenervationDevice: Renal Denervation Only

Interventions

Splanchnic Nerve DenervationDEVICE

Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation

CND of Renal Arteries and Splanchnic Nerves Arm
Renal Denervation OnlyDEVICE

Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation

CDN of Renal arteries ArmCND of Renal Arteries and Splanchnic Nerves Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Jefferson General Hospital

New Orleans, Louisiana, 70006, United States

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jose Wiley, MD, MPH, FACC, FACP, FSCAI

    Tulane University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Wang, MS

CONTACT

504-988-3065hwang37@tulane.edu

Suzanne Bowers, RN, BSN

CONTACT

504-988-2030sbowers@tulane.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

US(1)