Renal Denervation in Refractory Hypertension

Hypertension Clinical Trial

— PRAGUE-15  

Official title:

Renal Denervation - Hope for Patients With Refractory Hypertension?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01560312
• Other study ID #: Charles University
• Status: Terminated
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: January 2019
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 106
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Resistant to Conventional Therapy

Intervention

Device:
• Renal denervation (Symplicity® Catheter System™)
4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)

Locations

Country	Name	City	State
Czechia	Cardiocenter, University Hospital Olomouc	Olomouc
Czechia	Jiri Widimsky	Prague
Czechia	Cardiocenter Podlesi	Trinec

Sponsors (4)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Cardiocenter Podlesí, Trinec, Czech Republic, General University Hospital, Prague, University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Post-denervation renal anatomy assessment	CT angiography will be performed 1 year after RDN	1 year