Renal Denervation in Refractory Hypertension (PRAGUE-15)

This study has been terminated.
(Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.)
Sponsor:
Collaborators:
General University Hospital, Prague
University Hospital Olomouc
Cardiocenter Podlesí, Trinec, Czech Republic
Information provided by (Responsible Party):
Petr Widimsky, MD, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01560312
First received: March 19, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Resistant to Conventional Therapy
Device: Renal denervation (Symplicity® Catheter System™)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation - Hope for Patients With Refractory Hypertension?

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Blood pressure difference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months, 1, 2, 3 years ] [ Designated as safety issue: No ]
    changes in blood concentrations of renin, aldosterone, metanephrines and renal function

  • Post-denervation renal anatomy assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    CT angiography will be performed 1 year after RDN


Enrollment: 106
Study Start Date: October 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal denervation
Renal denervation + 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560312

Locations
Czech Republic
Cardiocenter, University Hospital Olomouc
Olomouc, Czech Republic
Jiri Widimsky
Prague, Czech Republic
Cardiocenter Podlesi
Trinec, Czech Republic
Sponsors and Collaborators
Charles University, Czech Republic
General University Hospital, Prague
University Hospital Olomouc
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
  More Information

No publications provided

Responsible Party: Petr Widimsky, MD, Head of Cardiocenter, 3rd Faculty of Medicine, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01560312     History of Changes
Other Study ID Numbers: Charles University
Study First Received: March 19, 2012
Last Updated: February 27, 2014
Health Authority: Czech Republic: Ministry of Health

Keywords provided by Charles University, Czech Republic:
Renal denervation
Resistant hypertension
Spironolactone
Long-term Outcome

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014