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Hypertension, Resistant to Conventional TherapyPhase 4DENER-HTNNCT01570777

Renal Denervation in Hypertension

A Phase 4 study testing renal denervation and optimized medication regimen and optimized medication regimen in people with Hypertension, Resistant to Conventional Therapy and Renal Denervation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
renal denervation and optimized medication regimen and optimized medication regimen
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteFrance
Study dates
Apr 2012to 15 May 2018
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individual is more than 18 and less than 75 years old at time of randomization
  • Essential hypertension diagnosed during a complete work-up within the past 2 years
  • Office blood pressure ≥140 and/or 90 mmHg despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, including a diuretic
  • 2 functional kidneys sizing ≥ 90 mm; eGFR ≥ 40 mL/min/1.73m² (MDRD formula)
  • Suitable renal anatomy compatible with the endovascular denervation procedure
  • Signed Informed consent
  • Confirmed resistant hypertension defined by diurnal ambulatory blood pressure measurement ≥ 135 and/or 85 mmHg after 4 week standardized triple antihypertensive treatment

Who cannot join

  • Patients with an estimated glomerular filtration rate (eGFR) of less than 40 mL/min/1.73 m2
  • Patients with secondary hypertension
  • Kaliemia ≥ 6mmol/L
  • Patient with single functioning kidney
  • Patient with contrast media allergy
  • Patient with any implantable device incompatible with radiofrequency energy delivery
Show all 12Show fewer
  • Patient with contra-indication to the anti-hypertensive standardized medication regimen
  • Patient with transient or fixed cerebral ischemia within 3 months before inclusion
  • Patient with myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
  • Patient with type 1 diabetes mellitus
  • Patient with malignancy within the 5 past years
  • Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm

Trial locations and contacts

1 site in 1 country.

France1 site

  • CIC Hopital europeen george pompidou

    Paris, 75015

Other trials in France

About this study

Official title: Renal Denervation in Patients With Resistant Hypertension

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Read the detailed description

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the efficacy and cost-effectiveness of renal denervation plus standardized optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment alone in patients with proven resistant hypertension. Patients with essential resistant hypertension will first enter a 4-week run-in period during which they will receive a standardized triple combination therapy (diuretic+ ACE inhibitor+ CCB at maximal dose). After 4 weeks of standardized triple therapy patients will be randomized to renal denervation + optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment if daytime ambulatory BP remains ≥ 135 and/or 85 mmHg. Bilateral renal denervation will be performed using the Symplicity Catheter (Medtronic ®) - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery. Study amendment: Extended follow-up of 48 months for all randomized patients.

Being tested
renal denervation and optimized medication regimen, optimized medication regimen
Keywords
Resistant hypertension, Renal denervation, Standardized medication regimen, Endovascular, Primary hypertension, Cardiovascular diseases, Vascular diseases
Medical subject headings
Hypertension Resistant to Conventional Therapy, Essential Hypertension, Cardiovascular Diseases, Vascular Diseases

What participants receive

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

  • renal denervation and optimized medication regimenProcedure or surgery

    Also called TMAOS + DR

    Patients are treated with the renal denervation plus a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.

  • optimized medication regimenProcedure or surgery

    Also called TMAOS

    Patients are treated with a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.

Study groups in NCT01570777
Study groupRoleWhat they receive
Renal denervationExperimentalNot described
Receives: Procedure: renal denervation and optimized medication regimen
optimized medication regimenOtheroptimized medication regimen
Receives: Procedure: optimized medication regimen

What is being measured

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

  1. Mean diurnal systolic blood pressure assessed by ABPM

    Measured: Baseline to 6 months

  2. Cost-effectiveness evaluation

    Measured: 1 year

Secondary outcomes (8)

  1. Antihypertensive medication score

    Measured: baseline to 15 months

  2. Adverse events of renal denervation

    Measured: baseline to 48 months

  3. Detailed analysis of blood pressure

    Measured: baseline to 15 months

  4. Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring

    Measured: baseline to 15 months

  5. Change in average 24-hour, daytime and nighttime diastolic Blood Pressure, pulse pressure and heart rate by ambulatory blood pressure monitoring

    Measured: baseline to 15 months

  6. Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring

    Measured: baseline to 15 months

  7. Change in office Systolic/diastolic Blood Pressure

    Measured: baseline to 15 months

  8. Adherence to antihypertensive Medication

    Measured: baseline to 15 months

Timeline

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

  1. First posted4 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionMay 2014
  4. Study completion15 May 2018

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01570777
Sponsor's protocol ID
P110127
Acronym
DENER-HTN
Status last verified
Sep 2018
First submitted
2 Apr 2012
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Hamdidouche I, Gosse P, Cremer A, Lorthioir A, Delsart P, Courand PY, Denolle T, Halimi JM, Girerd X, Ormezzano O, Rossignol P, Pereira H, Azizi M; DENERHTN Investigators. Clinic Versus Ambulatory Blood Pressure in Resistant Hypertension: Impact of Antihypertensive Medication Nonadherence: A Post Hoc Analysis the DENERHTN Study. Hypertension. 2019 Nov;74(5):1096-1103. doi: 10.1161/HYPERTENSIONAHA.119.13520. Epub 2019 Sep 23.

    PubMed 31995406

  • Courand PY, Pereira H, Del Giudice C, Gosse P, Monge M, Bobrie G, Delsart P, Mounier-Vehier C, Lantelme P, Denolle T, Dourmap C, Halimi JM, Girerd X, Rossignol P, Zannad F, Ormezzano O, Vaisse B, Herpin D, Ribstein J, Bouhanick B, Mourad JJ, Ferrari E, Chatellier G, Sapoval M, Azarine A, Azizi M; DENERHTN Investigators. Abdominal Aortic Calcifications Influences the Systemic and Renal Hemodynamic Response to Renal Denervation in the DENERHTN (Renal Denervation for Hypertension) Trial. J Am Heart Assoc. 2017 Oct 10;6(10):e007062. doi: 10.1161/JAHA.117.007062.

    PubMed 29018027

  • Gosse P, Cremer A, Pereira H, Bobrie G, Chatellier G, Chamontin B, Courand PY, Delsart P, Denolle T, Dourmap C, Ferrari E, Girerd X, Michel Halimi J, Herpin D, Lantelme P, Monge M, Mounier-Vehier C, Mourad JJ, Ormezzano O, Ribstein J, Rossignol P, Sapoval M, Vaisse B, Zannad F, Azizi M. Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation: The DENERHTN Study (Renal Denervation for Hypertension). Hypertension. 2017 Mar;69(3):494-500. doi: 10.1161/HYPERTENSIONAHA.116.08448. Epub 2017 Jan 23.

    PubMed 28115517

  • Azizi M, Pereira H, Hamdidouche I, Gosse P, Monge M, Bobrie G, Delsart P, Mounier-Vehier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Girerd X, Michel Halimi J, Zannad F, Ormezzano O, Vaisse B, Herpin D, Ribstein J, Chamontin B, Mourad JJ, Ferrari E, Plouin PF, Jullien V, Sapoval M, Chatellier G; DENERHTN Investigators. Adherence to Antihypertensive Treatment and the Blood Pressure-Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial. Circulation. 2016 Sep 20;134(12):847-57. doi: 10.1161/CIRCULATIONAHA.116.022922. Epub 2016 Aug 30.

    PubMed 27576780

  • Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P, Midulla M, Mounier-Vehier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Trillaud H, Pereira H, Plouin PF, Chatellier G; Renal Denervation for Hypertension (DENERHTN) investigators. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet. 2015 May 16;385(9981):1957-65. doi: 10.1016/S0140-6736(14)61942-5. Epub 2015 Jan 26.

    PubMed 25631070

  • Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available.

    PubMed 25186534

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing renal denervation and optimized medication regimen and optimized medication regimen in people with Hypertension, Resistant to Conventional Therapy and Renal Denervation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 7 inclusion and 12 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: finished, as of the sponsor's last update on 2 Oct 2018. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean diurnal systolic blood pressure assessed by ABPM (time frame: Baseline to 6 months). 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 NCT01570777, which also lists 6 linked publications.

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 2 Oct 2018.

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