Renal Denervation in Treatment Resistant Hypertension

Hypertension Clinical Trial

— ReSET-2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01762488
• Other study ID #: 35218
• Status: Terminated
• Phase: Phase 3
• First received: January 4, 2013
• Last updated: May 20, 2016
• Start date: January 2013

Study information

• Verified date: May 2016
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Procedure:
• Ablation of the renal arteries
Catheter-based renal denervation by applying low power radiofrequency to the renal artery using the EnligHTN Catheter, introduced by femoral artery access.
• Renal angiography
Renal angiography by femoral access

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus

Sponsors (6)

Lead Sponsor	Collaborator
Henrik Vase	Aarhus University Hospital, Central Jutland Regional Hospital, Randers Regional Hospital, Regional Hospital Holstebro, Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement)		6 months	No
Secondary	Change from baseline in blood pressure (clinic and 24-hour ambulatory blood pressure measurement)		3 and 6 months	No
Secondary	Change from baseline in central blood pressure, augmentation index and pulse wave velocity		6 months	No
Secondary	Change from baseline in cold pressor response		6 months	No
Secondary	Change from baseline in intensity of medical antihypertensive therapy		1, 3 and 6 months	No
Secondary	Blood pressure (clinic measurement)		1, 3 and 6 months	Yes
Secondary	Renal function (eGFR and electrolytes)		1, 3 and 6 months	Yes