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Renal Denervation in Treatment Resistant Hypertension (ReSET-2)

Primary Purpose

Hypertension

Status

Terminated

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Ablation of the renal arteries

Renal angiography

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Treatment Resistant Hypertension, Renal Denervation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Renal artery anatomy not suitable for renal artery ablation (Stenosis, diameter < 4 mm, length < 2 cm or severe calcifications)
Moderate/severe obstructive sleep apnoea (AHI > 15) if CPAP treatment has not been attempted

Sites / Locations

Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Renal denervation by ablation of the renal arteries

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Change from baseline in cold pressor response

Change from baseline in intensity of medical antihypertensive therapy

Blood pressure (clinic measurement)

Renal function (eGFR and electrolytes)

Full Information

NCT ID

NCT01762488

First Posted

January 4, 2013

Last Updated

May 20, 2016

Sponsor

Henrik Vase

Collaborators

Aarhus University Hospital, Regionshospitalet Silkeborg, Randers Regional Hospital, Central Jutland Regional Hospital, Regional Hospital Holstebro

1. Study Identification

Unique Protocol Identification Number

NCT01762488

Brief Title

Renal Denervation in Treatment Resistant Hypertension

Acronym

ReSET-2

Official Title

Renal Denervation in Treatment Resistant Hypertension, a Double-blind Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Study Start Date

January 2013 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Henrik Vase

Collaborators

Aarhus University Hospital, Regionshospitalet Silkeborg, Randers Regional Hospital, Central Jutland Regional Hospital, Regional Hospital Holstebro

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Treatment Resistant Hypertension, Renal Denervation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Renal denervation by ablation of the renal arteries

Arm Type

Active Comparator

Arm Description

Arm Title

Control

Arm Type

Sham Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Ablation of the renal arteries

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Renal angiography

Intervention Description

Renal angiography by femoral access

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Time Frame

3 and 6 months

Title

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

Time Frame

6 months

Title

Change from baseline in cold pressor response

Time Frame

6 months

Title

Change from baseline in intensity of medical antihypertensive therapy

Time Frame

1, 3 and 6 months

Title

Blood pressure (clinic measurement)

Time Frame

1, 3 and 6 months

Title

Renal function (eGFR and electrolytes)

Time Frame

1, 3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Renal artery anatomy not suitable for renal artery ablation (Stenosis, diameter < 4 mm, length < 2 cm or severe calcifications) Moderate/severe obstructive sleep apnoea (AHI > 15) if CPAP treatment has not been attempted

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrik Vase, MD, PhD

Organizational Affiliation

Skejby Hospital, Dept. of Cardiology

Official's Role

Study Chair

Facility Information:

Facility Name

Aarhus University Hospital, Skejby

City

Aarhus

ZIP/Postal Code

8200

Country

Denmark

12. IPD Sharing Statement

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Renal Denervation in Treatment Resistant Hypertension

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