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HypertensionNCT04535050

DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive Medications

A study testing Renal denervation and Renal angiography in people with Hypertension and Vascular Diseases, run by Kalos Medical at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Renal denervation and Renal angiography
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteGreece
Study dates
20 Oct 2022to 15 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 24-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

Who cannot join

  • 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)
Show all 34Show fewer
  • 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.
  • Subject requiring chronic oxygen support or mechanical ventilation (other than nocturnal respiratory support for sleep apnea)
  • Subject with primary pulmonary hypertension
  • Subject with untreated secondary cause of hypertension (known or suspected) or taking medications that increase sympathetic tone that could contribute to hypertension
  • Subject with frequent or chronic pain that requires treatment with NSAIDs for two or more days per week during the last month prior to Screening Visit 2 (aspirin and clopidogrel permitted for cardiovascular risk reduction)
  • Human immunodeficiency virus (HIV) on anti-retroviral drug therapy but without documentation that hypertension preceded initiation of anti-retroviral drug therapy
  • Subject with a history of myocardial infarction, stable or unstable angina, transient ischemic attack, cerebrovascular accident, heart failure, or atrial fibrillation within 3 months prior to Screening Visit 1
  • Subject who requires more than occasional use (e.g., PRN) of narcotic drugs over the month prior to Screening Visit 1
  • Subject currently taking anti-mineralocorticoid medications, unless weaned off by ≥ 8 weeks prior to Screening Visit 1
  • Subject with a history of bleeding diathesis or coagulopathy or subject who refuses blood transfusions
  • Subject working night shifts
  • Subject with a medical history of contraindications, anaphylactic reactions, or uncontrollable allergic reactions to contrast agents
  • Subject using active implantable medical devices (Implantable Cardioverter Defibrillator [ICD] or Cardiac Resynchronization Therapy Device [CRT-D], neuromodulation device, spinal cord stimulator, pressure reflector, etc.)
  • Subject with scheduled or planned surgery that may affect clinical investigation endpoints, in the opinion of the investigator
  • Subject has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic/office blood pressure monitor (e.g., upper arm circumference outside cuff size ranges available by geography or arrhythmia that interferes with automatic monitor's pulse sensing and prohibits an accurate measurement).
  • Subject with documented confounding medical condition that may adversely affect the safety of the subject, in the opinion of the investigator (e.g. clinically significant peripheral vascular disease, aortic aneurysm, severe cardiac valve stenosis for which a significant reduction of blood pressure is contraindicated, or bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia,)
  • Subject with known unresolved history of drug use or alcohol dependency, lacks ability to comprehend or follow instructions, or would be unlikely or unable to comply with clinical investigation follow-up requirements
  • Subject currently enrolled in a concurrent investigational drug or device clinical investigation, unless approved by clinical investigation sponsor
  • 23)25) Pregnant, nursing, or planning to become pregnant during the course of the clinical investigation or follow-up. A negative pregnancy test is required for all women of child- bearing potential.
  • Subject who is unsuitable for the study for any reason as judged by the investigator

Trial locations and contacts

1 site in 1 country.

EunHa Choi contact

82-2-527-5417

eunha.choi@kalosmedical.com

Greece1 site, 1 recruiting

  • University of Athens Hippocratio Hospital

    Athens

    Tsioufis Costas

    Tsioufis Costas

    Recruiting

Other trials in Greece

About this study

Official title: A Prospective, Multicenter, Sham-controlled, Single-blinded, Randomized, Pilot Study to Evaluate the Safety and Effectiveness of DENEX Renal Denervation System in Patients With Uncontrolled Hypertension Not Treated With Anti-HTN Medication

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.

Read the detailed description

DENEX system developed by Kalos Medical Inc. is a renal denervation system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.

Being tested
Renal denervation, Renal angiography
Keywords
Renal Denervation
Medical subject headings
Hypertension, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal denervationDevice

    Renal Denervation: DENEX system

  • Renal angiographyProcedure or surgery

    Renal angiography

Study groups in NCT04535050
Study groupRoleWhat they receive
DENEX Renal denervationExperimentalSubjects are treated with the renal denervation procedure after randomization
Receives: Device: Renal denervation
Sham controlSham comparatorSubjects are treated with renal angiography
Receives: Procedure: Renal angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 24-h ambulatory systolic blood pressure

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

    Measured: from baseline to 3 months post-procedure

  2. Incidence of MAE within 3 months post-procedure

    Incidence of MAE within 3 months post-procedure

    Measured: within 3 months post-procedure

Secondary outcomes (15)

  1. Changes in 24-h ambulatory systolic blood pressure

    Changes in 24-h ambulatory SBP from baseline to 6, 12, and 24 months post-procedure

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

  2. Changes in 24-h ambulatory diastolic blood pressure

    Changes in 24-h ambulatory DBP from baseline to 3, 6, 12, and 24 months post-procedure

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

  3. Changes in office systolic blood pressure

    Changes in office SBP from baseline to 1, 3, 6, 12, and 24 months post-procedure

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

  4. Changes in office diastolic blood pressure

    Changes in office DBP from baseline to 1, 3, 6, 12, and 24 months post-procedure

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

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

    Incidence of achieving target office SBP (< 140 mmHg) from baseline to 1, 3, 6, 12, and 24 months post-procedure

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

  6. Changes in heart rate

    Changes in heart rate from baseline to 3, 6, 12, and 24 months post-procedure

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

  7. Incidence of AEs, SAEs, ADE, and SADE

    Incidence of Adverse Events (AEs), SAEs, Adverse Device Effects (ADE), and Serious Adverse Device Effects (SADE) at 1, 3, 6, 12, and 24 months post-procedure

    Measured: at 1, 3, 6, 12, and 24 months post-procedure

  8. Incidence of MAE

    Incidence of MAEs at 6, 12, and 24 months post-procedure

    Measured: at 6, 12, and 24 months post-procedure

  9. Incidence of significant embolic event resulting in end-organ damage, incidence of renal artery perforation requiring intervention, incidence of renal artery dissection requiring intervention, incidence of vascular complications

    Incidence of significant embolic event resulting in end-organ damage, incidence of renal artery perforation requiring intervention, incidence of renal artery dissection requiring intervention, incidence of vascular complications at 1 month post-procedure

    Measured: at 1 month post-procedure

  10. Incidence of all-cause mortality

    Incidence of all-cause mortality at 3, 6, 12, and 24 months post-procedure

    Measured: at 3, 6, 12, and 24 months post-procedure

  11. Incidence of end-stage renal disease, incidence of ≥ 40% decline in eGFR, incidence of new myocardial infarction, incidence of new stroke, incidence of renal artery reintervention

    Incidence of end-stage renal disease, incidence of ≥ 40% decline in estimated glomerular filtration rate (eGFR), incidence of new myocardial infarction, incidence of new stroke, incidence of renal artery reintervention at 1, 3, 6, 12, and 24 months post-procedure

    Measured: at 1, 3, 6, 12, and 24 months post-procedure

  12. Incidence of major bleeding according to Thrombolysis in Myocardial Infarction (TIMI) definition

    Incidence of major bleeding according to Thrombolysis in Myocardial Infarction (TIMI) definition at 1, 3, 6, 12, and 24 months post-procedure (intracranial hemorrhage, ≥ 5 g/dL decrease in hemoglobin concentration, ≥ 15% absolute decrease in hematocrit, or death due to bleeding within 7 days of procedure)

    Measured: at 1, 3, 6, 12, and 24 months post-procedure

  13. Incidence or increase in serum creatinine > 50%

    Incidence or increase in serum creatinine > 50% at 1, 3, 6, 12, and 24 months post-procedure

    Measured: at 1, 3, 6, 12, and 24 months post-procedure

  14. Incidence of new renal artery stenosis > 70%

    Incidence of new renal artery stenosis > 70% at 3 months post-procedure, as assessed by Computed Tomography (CT), Magnetic Resonance Angiography (MRA), or Doppler Ultrasonography (DUS)

    Measured: at 3 months post-procedure

  15. Incidence of hospitalization for hypertensive crisis not related to confirmed non-adherence or the CIP

    Incidence of hospitalization for hypertensive crisis not related to confirmed non-adherence or the CIP at 1, 3, 6, 12, and 24 months post-procedure

    Measured: at 1, 3, 6, 12, and 24 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2020
  2. Study start20 Oct 2022
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion15 Apr 2026 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04535050
Sponsor's protocol ID
DN_E101
Status last verified
Feb 2023
First submitted
27 Aug 2020
Last updated
20 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Renal denervation and Renal angiography in people with Hypertension and Vascular Diseases, run by Kalos Medical at 1 site in Greece.

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 8 inclusion and 34 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. 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 Greece. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact EunHa Choi (82-2-527-5417, eunha.choi@kalosmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-h ambulatory systolic blood pressure (time frame: from baseline to 3 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535050.

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 20 Mar 2023.

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