RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157

Hypertension, Renal Clinical Trial

— RENABLATE-II  

Official title:

A Prospective, Multi-center, Non-Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE-II - 157)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095691
• Other study ID #: RENABLATE-II
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2014
• Last updated: October 30, 2015
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlBelgium: Federal Agency for Medicines and Health Products, FAMHPItaly: The Italian Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosNew Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Subject has a systolic blood pressure = 140 mmHg based on an average of 3 office blood pressure readings measured according to the BP guidelines.

2. Subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months.

3. Subject is > 18 and < 85 years of age.

4. Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.

Key Exclusion Criteria:

1. A secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h ABPM at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, Adult Polycystic kidney Disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, Cushing's Syndrome, Conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment.

2. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).

3. Subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.

4. Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery.

5. Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD formula.

6. Subject has type 1 diabetes mellitus.

7. Subject has history of Myocardial Infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques.

8. Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Renal

Intervention

Device:
• Celsius® ThermoCool® Renal Denervation
The investigational device is indicated for the treatment of resistant hypertension by renal denervation.

Locations

Country	Name	City	State
Czech Republic	Charles University Hospital	Prague
Czech Republic	Na Homolce Hospital	Prague
Italy	Ospedale Generale Regionale	Bari
New Zealand	Mercy Angiography	Epsom	Auckland
Spain	Hospital Universitari Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Czech Republic,  Italy,  New Zealand,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.	Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.	30 days post-procedure	Yes
Secondary	Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit	These adverse events include renal artery stenosis (=60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; =25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.	12 months post-procedure	Yes
Secondary	Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure	Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.	12 months post-procedure	No
Secondary	Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure	The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.	12 months post-procedure	No
Secondary	Incidence of Subjects Achieving a = 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure	Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.	12 months post-procedure	No