Renal Denervation in Refractory Hypertension (PRAGUE-15)

Renal Denervation - Hope for Patients With Refractory Hypertension?

Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.

Study Overview

• Status: Terminated
• Conditions: Hypertension; Resistant to Conventional Therapy
• Intervention / Treatment: Device: Renal denervation (Symplicity® Catheter System™)

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia
    • Cardiocenter, University Hospital Olomouc
  • Prague, Czechia
    • Jiri Widimsky
  • Trinec, Czechia
    • Cardiocenter Podlesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Refractory hypertension with office SBP > 140 mmHg
• SBP > 130 during 24-hours Holter blood pressure monitoring
• Treatment with the least 3 antihypertensive medications including diuretics in optimal doses
• Age > 18 years
• Signed informed consent

Exclusion Criteria:

• Secondary forms of hypertension
• Chronic renal disease (serum creatinine > 200 umol/l)
• Pregnancy
• History of myocardial infarction or stroke in last 6 months
• Severe valvular stenotic disease
• Anatomic abnormalities and variants of renal artery including aneurysms, severe stenosis, reference diameter < 4 mm or length < 20 mm
• Increased bleeding risk (thrombocytopenia < 50, INR > 1.5)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal denervation; Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization)	Device: Renal denervation (Symplicity® Catheter System™); 4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)
No Intervention: Medical treatment; Conventional antihypertensive treatment including spironolactone (if not contraindicated). One year after randomization, renal denervation can be performed according to the physician's decision based on the BP levels and if patient desires the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure difference	Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure differences similar to primary outcome	Systolic and Diastolic BP differences (comparison between baseline and evaluated time period) will be measured using 24-hours monitoring and also at office.	1 year, 2 years, 3 years
Change of blood laboratory parameters and renal function	changes in blood concentrations of renin, aldosterone, metanephrines and renal function	6 months, 1, 2, 3 years
Post-denervation renal anatomy assessment	CT angiography will be performed 1 year after RDN	1 year

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: University Hospital Olomouc; General University Hospital, Prague; Cardiocenter Podlesí, Trinec, Czech Republic
• Investigators: Principal Investigator: Petr Widimsky, Prof, MD, Charles University, Prague, Czech Republic; Principal Investigator: Jiri Widimsky, Prof.MD., General University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Spironolactone; Renal denervation; Resistant hypertension; Long-term Outcome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Charles University