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Renal Denervation in Refractory Hypertension (PRAGUE-15)

Primary Purpose

Hypertension, Resistant to Conventional Therapy

Status
Terminated
Phase
Phase 3
Locations
Czechia
Study Type
Interventional
Intervention
Renal denervation (Symplicity® Catheter System™)
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Renal denervation, Resistant hypertension, Spironolactone, Long-term Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cardiocenter, University Hospital Olomouc
  • Jiri Widimsky
  • Cardiocenter Podlesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Renal denervation

Medical treatment

Arm Description

Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization)

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change of blood laboratory parameters and renal function
changes in blood concentrations of renin, aldosterone, metanephrines and renal function
Post-denervation renal anatomy assessment
CT angiography will be performed 1 year after RDN

Full Information

First Posted
March 19, 2012
Last Updated
January 30, 2019
Sponsor
Charles University, Czech Republic
Collaborators
General University Hospital, Prague, University Hospital Olomouc, Cardiocenter Podlesí, Trinec, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT01560312
Brief Title
Renal Denervation in Refractory Hypertension
Acronym
PRAGUE-15
Official Title
Renal Denervation - Hope for Patients With Refractory Hypertension?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
Collaborators
General University Hospital, Prague, University Hospital Olomouc, Cardiocenter Podlesí, Trinec, Czech Republic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Resistant to Conventional Therapy
Keywords
Renal denervation, Resistant hypertension, Spironolactone, Long-term Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal denervation
Arm Type
Experimental
Arm Description
Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization)
Arm Title
Medical treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Renal denervation (Symplicity® Catheter System™)
Intervention Description
4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)
Primary Outcome Measure Information:
Title
Blood pressure difference
Description
Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Blood pressure differences similar to primary outcome
Description
Systolic and Diastolic BP differences (comparison between baseline and evaluated time period) will be measured using 24-hours monitoring and also at office.
Time Frame
1 year, 2 years, 3 years
Title
Change of blood laboratory parameters and renal function
Description
changes in blood concentrations of renin, aldosterone, metanephrines and renal function
Time Frame
6 months, 1, 2, 3 years
Title
Post-denervation renal anatomy assessment
Description
CT angiography will be performed 1 year after RDN
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Widimsky, Prof, MD
Organizational Affiliation
Charles University, Prague, Czech Republic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiri Widimsky, Prof.MD.
Organizational Affiliation
General University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiocenter, University Hospital Olomouc
City
Olomouc
Country
Czechia
Facility Name
Jiri Widimsky
City
Prague
Country
Czechia
Facility Name
Cardiocenter Podlesi
City
Trinec
Country
Czechia

12. IPD Sharing Statement

Learn more about this trial

Renal Denervation in Refractory Hypertension

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