Renal Denervation Therapy for High Blood Pressure

Recruiting at 4 trial locations

Overseen By George K Chow, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DeepQure Inc.

Must be taking: Antihypertensives, Diuretics

Must not be taking: NSAIDs, Anticoagulants

Disqualifiers: Unstable angina, Myocardial infarction, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be on at least three different blood pressure medications, including a diuretic, for at least four weeks before joining the study.

What data supports the effectiveness of the treatment HyperQureTM RDN System for high blood pressure?

Research shows that renal denervation (RDN) can reduce blood pressure in patients with resistant hypertension, especially when other medications are not effective. Some studies have found it to be safe and potentially beneficial, although results can vary. ^{1 2 3 4 5}

Is renal denervation therapy safe for humans?

Renal denervation therapy has been shown to be generally safe in humans, as studies have reported its safety in patients with high blood pressure, including those with chronic kidney disease and treatment-resistant hypertension. ^{5 6 7 8 9}

How is the HyperQureTM RDN System treatment different from other treatments for high blood pressure?

The HyperQureTM RDN System is unique because it uses renal denervation (RDN), a procedure that targets the nerves in the kidneys to lower blood pressure, especially in patients whose high blood pressure does not respond to standard medications. This approach is different from typical drug treatments as it involves a catheter-based procedure rather than oral medication. ^{1 2 4 10 11}

What is the purpose of this trial?

HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications

Eligibility Criteria

This trial is for patients with resistant hypertension who are taking three or more blood pressure medications without success. It's not suitable for individuals with certain types of heart conditions, kidney diseases, or those who've had previous renal artery interventions.

Inclusion Criteria

I am between 22 and 80 years old.

Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 23

My high blood pressure does not improve with medication.

Exclusion Criteria

My renal artery is either less than 2 mm or more than 11 mm wide.

I had a stent placed for unstable angina less than 3 months ago.

I have had a heart attack in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic renal denervation therapy using the HyperQureTM RDN System under general anesthesia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness with various blood pressure evaluations and imaging scans

36 months

Regular visits at 1, 3, 6, 12, 24, and 36 months post-procedure

Long-term Monitoring

Participants continue to be monitored for chronic adverse events and changes in antihypertensive medication usage

36 months

Treatment Details

Interventions

• HyperQureTM RDN System

Trial Overview The study is testing the 'HyperQureTM RDN System', a new laparoscopic procedure aimed at lowering high blood pressure by disrupting nerves in the kidneys that contribute to hypertension.

Participant Groups

Group I: Extravsacular(Laparoscopic) Renal Denervation Experimental Treatment 1 Intervention

Intervention: Device: HyperQureTM Renal Denervation (RDN) System: * HyperQureTM RDN Generator * HyperQureTM RDN Laparoscopic Instrument

Who Is Running the Clinical Trial?

DeepQure Inc.

Lead Sponsor

Trials

2

Recruited

30+

Findings from Research

Renal denervation (RDN) has shown promising results in a randomized study of 104 patients with treatment-resistant hypertension, leading to an average blood pressure reduction of 32/12 mm Hg in the treatment group, while the control group saw no change.

Despite the positive outcomes, further evidence is needed from larger studies, including a pending trial in the USA with 530 participants, to confirm RDN's effectiveness and safety before it can be widely recommended as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Renal sympathetic denervation in treatment-resistant hypertension]. Sørensen, H., Fadl Elmula, FE., Kjeldsen, SE., et al.[2016]

In a trial involving 337 patients with uncontrolled hypertension on antihypertensive medications, renal denervation (RDN) did not show a significant difference in 24-hour ambulatory systolic blood pressure compared to a sham control after 6 months, with a treatment difference of -1.9 mm Hg (P = 0.12).

Despite the primary analysis showing no significant difference, RDN was associated with a notable reduction in office systolic blood pressure (-4.9 mm Hg, P = 0.0015) and had favorable outcomes in several secondary analyses, indicating potential benefits of RDN in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. Kandzari, DE., Townsend, RR., Kario, K., et al.[2023]

Renal denervation (RDN) significantly reduced renal vascular resistance in patients with drug-resistant hypertension and type 2 diabetes, particularly in those with elevated baseline renal resistive index (RRI ≥ 0.7).

While RDN did not significantly change estimated glomerular filtration rate (eGFR), it effectively lowered blood pressure by an average of -10.9 mmHg systolic and -5.5 mmHg diastolic after 12 months, indicating its potential as a treatment option for managing hypertension in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Favorable effect of renal denervation on elevated renal vascular resistance in patients with resistant hypertension and type 2 diabetes mellitus. Manukyan, M., Falkovskaya, A., Mordovin, V., et al.[2023]

Catheter-based renal denervation effectively reduced systolic blood pressure in patients with resistant hypertension, with significant reductions observed over a 3-year follow-up in both groups of patients studied (31 total participants).

Patients with accessory renal arteries experienced less pronounced reductions in pulse pressure compared to those with bilateral single renal arteries, indicating that the anatomical differences may influence the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure reduction in patients with accessory renal arteries and bilateral single renal arteries after catheter-based renal denervation: a prospective study with 3-year follow-up. Bartus, K., Podolec, J., Sadowski, J., et al.[2022]

Renal denervation therapy (RDN) has been found to be safe for patients with resistant hypertension, but its effectiveness in lowering blood pressure is variable and not significantly better than standard medical therapy.

Recent studies and ongoing trials are focusing on improving the procedural aspects of RDN and identifying patients who truly have treatment-resistant hypertension, which may help uncover potential benefits of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status of Renal Denervation in Hypertension. Briasoulis, A., Bakris, GL.[2018]

Renal denervation (RDN) significantly reduced both office and 24-hour ambulatory blood pressure in patients with chronic kidney disease (CKD) one month after the procedure, with effects lasting up to 24 months.

The procedure was found to be safe, with minimal major complications reported, and it did not adversely affect kidney function as measured by estimated glomerular filtration rate (eGFR).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of renal denervation for hypertension in patients with chronic kidney disease: a meta-analysis. Xia, M., Liu, T., Chen, D., et al.[2021]

Catheter-based renal denervation (RDN) significantly reduced both 24-hour and office systolic blood pressure in patients with uncontrolled hypertension, with a mean difference of -4.02 mm Hg and -8.93 mm Hg respectively, based on a meta-analysis of 12 randomized controlled trials involving 1539 individuals.

RDN was found to be safe, as it did not increase the risk of major adverse events, indicating that it can be an effective treatment option for managing high blood pressure without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Catheter-Based Renal Denervation on Uncontrolled Hypertension: A Systematic Review and Meta-analysis. Cheng, X., Zhang, D., Luo, S., et al.[2020]

Renal denervation (RDN) significantly reduced blood pressure in patients with mild to moderate resistant hypertension, showing a notable decrease in both systolic and diastolic blood pressure at the 6-month follow-up, compared to baseline measurements.

The procedure was safe, with no severe adverse events reported, and it allowed for a reduction in the number of antihypertensive medications needed by patients, indicating its potential as an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal denervation for mild-moderate treatment-resistant hypertension : A timely intervention? Chen, S., Kiuchi, MG., Schmidt, B., et al.[2020]

The Global Paradise™ System (GPS) registry aims to evaluate the long-term safety and effectiveness of ultrasound renal denervation (uRDN) in up to 3000 patients with hypertension over a 5-year follow-up period, providing valuable real-world data.

By focusing on standardized home blood pressure measurements and patient-reported outcomes, the study seeks to enhance understanding of uRDN's impact on blood pressure control and quality of life in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design. Mahfoud, F., Azizi, M., Daemen, J., et al.[2023]

A case report of a 49-year-old man with drug-resistant hypertension demonstrated that using a guide extension catheter can successfully enable renal denervation in highly tortuous renal arteries, which is typically challenging.

The patient experienced a significant decrease in ambulatory blood pressure one month after the procedure, indicating the efficacy of this method for treating resistant hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal denervation in a patient with a highly tortuous renal artery using a guide extension catheter: a case report. Wang, P., Wan, J., Hou, J., et al.[2021]

Percutaneous transcatheter renal sympathetic denervation (RDN) can significantly lower systolic blood pressure (SBP) by an average of 30 mmHg, with 85% of patients maintaining a reduction of 10 mmHg or more for up to two years, which may lead to lower rates of stroke and heart attacks.

RDN not only reduces blood pressure but also improves glycaemic control and reverses left ventricular hypertrophy, with potential additional benefits for renal function, sleep apnea, and heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human use of the OneShot™ renal denervation system from Covidien. Ormiston, JA., Watson, T., van Pelt, N., et al.[2016]

References

1. Norway pubmed.ncbi.nlm.nih.gov

[Renal sympathetic denervation in treatment-resistant hypertension]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Favorable effect of renal denervation on elevated renal vascular resistance in patients with resistant hypertension and type 2 diabetes mellitus. [2023]

4. Poland pubmed.ncbi.nlm.nih.gov

Blood pressure reduction in patients with accessory renal arteries and bilateral single renal arteries after catheter-based renal denervation: a prospective study with 3-year follow-up. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Current Status of Renal Denervation in Hypertension. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of renal denervation for hypertension in patients with chronic kidney disease: a meta-analysis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Effect of Catheter-Based Renal Denervation on Uncontrolled Hypertension: A Systematic Review and Meta-analysis. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Renal denervation for mild-moderate treatment-resistant hypertension : A timely intervention? [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Renal denervation in a patient with a highly tortuous renal artery using a guide extension catheter: a case report. [2021]

11. France pubmed.ncbi.nlm.nih.gov

First-in-human use of the OneShot™ renal denervation system from Covidien. [2016]