Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial (ReSET)
|ClinicalTrials.gov Identifier: NCT01459900|
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : September 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Procedure: Renal artery ablation Procedure: Renal angiography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Active Comparator: Renal artery ablation
By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to active treatment, renal artery ablation will be carried out straight away.
Procedure: Renal artery ablation
Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.
Sham Comparator: Sham
By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed.
Procedure: Renal angiography
Renal angiography by femoral access.
- 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.
- 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.
- Echocardiography [ Time Frame: 6 months ]Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.
- Biomarkers [ Time Frame: 1 months ]Biomarkers concerning renal sodium excretion
- Applanation tonometry [ Time Frame: 6 months ]Pulse wave velocity, augmentation index, central BP estimates
- forearm plethysmography [ Time Frame: 6 months ]Forearm minimum vascular resistance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459900
|Aarhus, Aarhus N, Denmark, 8200|
|Principal Investigator:||Ole N Mathiassen, MD, PhD||Aarhus University Hospital, Dep. Cardiology|