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The RESPLASH Study

Renal and Splanchnic Sympathetic Denervation as an Alternative Therapy for Resistant Hypertension and Type 2 Diabetes (RESPLASH Study)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The RESPLASH Study tests whether using heat from radio waves to treat nerves near the kidney arteries, then nerves in the belly, is safe and works. The treatment uses a thin tube called a catheter. It aims to improve blood pressure and blood sugar in people with type 2 diabetes whose blood pressure stays high despite medicines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–75 years old.
  • You have had type 2 diabetes for at least 5 years.
  • Your HbA1c, a measure of average blood sugar, is 6.5% or higher.
  • You take at least 1 diabetes medicine by mouth, with no changes in the past 30 days.
  • Your top blood pressure number stays at 160 or higher (150 or higher with type 2 diabetes), despite taking at least 3 blood pressure medicines as directed.
  • You take at least 3 blood pressure medicines, with no changes for 2 weeks before joining.

Who can't join

  • Your kidney filtering test result, called eGFR, is below 30.
  • You have type 1 diabetes.
  • An artery scan just before treatment shows a bulge or tear in the aorta, the body's main artery, that would prevent the procedure.
  • Your blood pressure drops when you stand up.
  • You have a sudden or severe infection affecting your body.
  • You had a heart attack, unstable angina (new or worsening heart-related chest pain), or stroke in the past 3 months.
  • You have already had catheter treatment to disable nerves near the kidney arteries.
  • You are pregnant, plan to become pregnant during the study, or cannot give informed consent (agree to join after learning about the study).

Simplified for readability. The official criteria below are what the study team uses.

Official 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% * 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.

Study sites (1)

LA