Renal Denervation in Refractory Hypertension (PRAGUE-15)

Charles University, Czech Republic

Status and phase: Terminated; Phase 3

Conditions: Hypertension; Resistant to Conventional Therapy

Treatments: Device: Renal denervation (Symplicity® Catheter System™)

Study type: Interventional

Funder types: Other

Identifiers

NCT01560312

Charles University

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Renal denervation

Experimental group

Description:

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

Treatment:

Device: Renal denervation (Symplicity® Catheter System™)

Medical treatment

No Intervention group

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.