DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive Medications

NCT04535050 | Recruiting

• 1 other identifier: DN_E101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of renal denervation using DENEX System in patients with hypertension without antihypertensive medication, compared with the sham group.

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases

Keywords

Renal Denervation

Outcome Measures

Primary Outcomes (2)

• Change in 24-h ambulatory systolic blood pressure

  Change in 24-h ambulatory systolic blood pressure from baseline to 3 months post-procedure

  from baseline to 3 months post-procedure

• Incidence of MAE within 3 months post-procedure

  Incidence of MAE within 3 months post-procedure

  within 3 months post-procedure

Secondary Outcomes (15)

• Changes in 24-h ambulatory systolic blood pressure

  from baseline to 6, 12, and 24 months post-procedure

• Changes in 24-h ambulatory diastolic blood pressure

  from baseline to 3, 6, 12, and 24 months post-procedure

• Changes in office systolic blood pressure

  from baseline to 1, 3, 6, 12, and 24 months post-procedure

• Changes in office diastolic blood pressure

  from baseline to 1, 3, 6, 12, and 24 months post-procedure

• Incidence of achieving target office systolic blood pressure (< 140 mmHg)

  from baseline to 1, 3, 6, 12, and 24 months post-procedure

Study Arms (2)

DENEX Renal denervation

EXPERIMENTAL

Subjects are treated with the renal denervation procedure after randomization

Device: Renal denervation

Sham control

SHAM COMPARATOR

Subjects are treated with renal angiography

Procedure: Renal angiography

Interventions

Renal denervation DEVICE

Renal Denervation: DENEX system

DENEX Renal denervation

Renal angiography PROCEDURE

Renal angiography

Sham control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged 18 to 80 years old at the time of signing the informed consent
• Subject who is drug-naïve or willing to discontinue current antihypertensive treatment (not on antihypertensive medications for at least 4 weeks prior to Screening Visit 1) at Screening Visit 1 through the 3-month post-procedure visit. Drug-naïve is defined as those with no previous exposure to antihypertensive medications.
• Subject who meets all of the following blood pressure measurements:
• Office Systolic Blood Pressrue (SBP) \< 180 mmHg at Screening Visit 1
• Office SBP ≥ 150 mmHg and \< 180 mmHg, and office diastolic blood pressure (DBP) ≥ 90 mmHg at Screening Visit 2
• h ambulatory SBP ≥ 140 mmHg and \< 170 mmHg at Screening Visit 2
• Subject who voluntarily decides to participate in this clinical study and sign the written consent.
• Subject who willing and able to complete all clinical investigation-related procedures and assessments

You may not qualify if:

• Subject with renal anatomy that is ineligible for treatment:
• Diameter of main renal artery for each kidney is \< 3 mm or \> 8 mm OR presence of accessory renal arteries (ARAs) with a diameter \< 3 mm
• Presence of fibromuscular dysplasia
• Presence of kidney tumors or secretory tumors in the adrenal gland
• \> 50% stenosis in any treatable vessel
• Presence of aneurysm (any localized increase in vessel diameter)
• Treatment area within 5 mm segment in the renal artery contains an atheroma, calcification, or a renal artery stent
• A single functioning kidney
• Polycystic kidney disease
• Subject with prior renal denervation, renal artery stenting, renal artery angioplasty, renal nephrectomy, or renal transplant
• Subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c over 10.0%)
• Subject with epidermal growth factor receptor (eGFR) \< 45 mL/min/1.73 m2, using the 4-variable modification of diet in renal disease (MDRD) clinical investigation calculation
• Subject taking sodium glucose co-transporter 2 (SGLT2) inhibitors or glucagon like peptide-1 (GLP-1) agonists that have been prescribed \< 90 days prior to Screening Visit 1 or necessary to remain on these medications for duration of clinical investigation
• Subject with ≥ 1 episode of orthostatic hypotension not related to medication changes within the past year prior to Screening Visit 1
• Documented repeated (\> 1) hospitalization for hypertensive crisis within the 12 months and/or any hospitalization for hypertensive crisis within the 3months prior to Screening Visit 1.

Sponsors & Collaborators

• Kalos Medical: lead

Study Sites (1)

University of Athens Hippocratio Hospital

Athens, Greece

RECRUITING

MeSH Terms

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Konstantinos Tsioufis, Professor

  National and Kapodistrian University of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Felix Mahfoud, Professor

  Saarland University Hospital, Homburg

  STUDY DIRECTOR

• Massimo Volpe, Professor

  University of Roma La Sapienza

  STUDY DIRECTOR

• Jacek Kadziela, Professor

  Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EunHa Choi

CONTACT

82-2-527-5417; eunha.choi@kalosmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: October 20, 2022
• Primary Completion: December 30, 2023
• Study Completion: April 15, 2026
• Last Updated: March 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)