NCT01762488

Brief Summary

The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

3.1 years

First QC Date

January 4, 2013

Last Update Submit

May 20, 2016

Conditions

Hypertension

Keywords

Treatment Resistant HypertensionRenal Denervation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement)

    6 months

Secondary Outcomes (6)

  • Change from baseline in blood pressure (clinic and 24-hour ambulatory blood pressure measurement)

    3 and 6 months

  • Change from baseline in central blood pressure, augmentation index and pulse wave velocity

    6 months

  • Change from baseline in cold pressor response

    6 months

  • Change from baseline in intensity of medical antihypertensive therapy

    1, 3 and 6 months

  • Blood pressure (clinic measurement)

    1, 3 and 6 months

  • +1 more secondary outcomes

Study Arms (2)

Renal denervation by ablation of the renal arteries

ACTIVE COMPARATOR

By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to active treatment, renal artery ablation will be carried out straight away.

Procedure: Ablation of the renal arteries

Control

SHAM COMPARATOR

By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to sham treatment, the procedure stops.

Procedure: Renal angiography

Interventions

Ablation of the renal arteriesPROCEDURE

Catheter-based renal denervation by applying low power radiofrequency to the renal artery using the EnligHTN Catheter, introduced by femoral artery access.

Renal denervation by ablation of the renal arteries
Renal angiographyPROCEDURE

Renal angiography by femoral access

Control

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systolic daytime (24 hour-ambulatory blood pressure measurement) \> 135 mmHg and \< 145 mmHg.
  • Stable (for at least 1 month and with no planned changes for the next 6 months) antihypertensive therapy with at least 3 antihypertensive drugs, including a diuretic.
  • Documented adherence to present antihypertensive therapy

You may not qualify if:

  • Pregnancy
  • Non compliance
  • Heart failure (NYHA Class III-IV)
  • LV ejection fraction \< 50 %
  • Renal insufficiency (eGFR\<30 ml/min)
  • Unstable coronary heart disease
  • Coronary intervention within 6 months
  • Myocardial infarction within 6 months
  • Claudication
  • Orthostatic syncope within 6 months
  • Secondary hypertension (except CKD)
  • Significant valvular heart disease
  • Clinically significant biochemical abnormalities (electrolytes, haemoglobin, hepatic function, thyroid)
  • Second and third degree AV block
  • Macroscopic haematuria
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Henrik Vase, MD, PhD

    Skejby Hospital, Dept. of Cardiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 7, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2016

Last Updated

May 23, 2016

Record last verified: 2016-05

Locations

DK(1)