Renal Denervation in Treatment Resistant Hypertension

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01762488

Acronym

ReSET-2

Enrollment

Registered

2013-01-07

Start date

2013-01-31

Completion date

Unknown

Last updated

2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Treatment Resistant Hypertension, Renal Denervation

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.

Interventions

PROCEDUREAblation 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.

PROCEDURERenal angiography

Renal angiography by femoral access

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement)	6 months

Secondary

Measure	Time frame
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 blood pressure (clinic and 24-hour ambulatory blood pressure measurement)	3 and 6 months
Blood pressure (clinic measurement)	1, 3 and 6 months
Renal function (eGFR and electrolytes)	1, 3 and 6 months
Change from baseline in intensity of medical antihypertensive therapy	1, 3 and 6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026