Renal Denervation in Treatment Resistant Hypertension

Phase 3TerminatedNCT01762488

Henrik Vase8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension

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 angiographyPROCEDURE

Renal angiography by femoral access

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Aarhus University Hospital, Skejby

Aarhus, Denmark

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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

Time frame: 3 and 6 months

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

Time frame: 6 months

Change from baseline in cold pressor response

Time frame: 6 months

Change from baseline in intensity of medical antihypertensive therapy

Time frame: 1, 3 and 6 months

Blood pressure (clinic measurement)

Time frame: 1, 3 and 6 months

Renal function (eGFR and electrolytes)

Time frame: 1, 3 and 6 months

Data from ClinicalTrials.gov

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