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Completed

NCT Number: NCT01459900

Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skejby Hospital

Aarhus, Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.

Exclusion criteria

  • Pregnancy
  • Non compliance
  • Heart Failure (NYHA 3-4)
  • LV ejection fraction < 50 %
  • Renal insufficiency (eGFR<30)
  • Unstable coronary heart disease
  • Coronary intervention within 6 months
  • Myocardial infarction within 6 months
  • Claudication
  • Orthostatic syncope within 6 months
  • Secondary Hypertension
  • Permanent atrial fibrillation
  • Significant Heart Valve Disease
  • Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
  • Second and third degree heart block
  • Macroscopic haematuria
  • Proximal significant coronary stenosis
  • Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter < 4 mm, length < 2 cm, multiple renal arteries, severe calcifications)

Treatment and study plan

Renal artery ablation

Procedure

Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.

Renal angiography

Procedure

Renal angiography by femoral access.

Primary outcomes

  1. daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement

    Time frame: 3 months follow up

    Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs.

Secondary outcomes

  1. ambulatory 24 hours BP measurements

    Time frame: 1, 3 and 6 months

    Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation.

  2. Echocardiography

    Time frame: 6 months

    Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.

  3. Biomarkers

    Time frame: 1 months

    Biomarkers concerning renal sodium excretion

  4. Applanation tonometry

    Time frame: 6 months

    Pulse wave velocity, augmentation index, central BP estimates

  5. forearm plethysmography

    Time frame: 6 months

    Forearm minimum vascular resistance

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

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

Registry information

Acronym: ReSET

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 26, 2011
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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