Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

Hypertension Clinical Trial

— HTN-4  

Official title:

Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972139
• Other study ID #: HTN-4
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: April 24, 2017
• Start date: October 2013
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.

Description:

After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2017
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic

• Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg

• Individual has ABPM average SBP greater than or equal to 135 mmHg

Exclusion Criteria:

• Individual lacks appropriate renal artery anatomy

• Individual has eGFR of less than 30

• Individual has Type I diabetes mellitus

• Individual has had one or more episodes of orthostatic hypotension

• Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea

• Individual has primary pulmonary hypertension

• Individual has other concomitant conditions that may adversely affect the patient or the study outcomes

• Individual is pregnant, nursing or planning to be pregnant

• Individual has had a previous organ transplant

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

Device:
• Renal Denervation using the Symplicity Renal Denervation System
Subjects randomized to the renal denervation group underwent angiography and renal denervation.

Other:
• Sham Renal Denervation
Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.

Device:
• Renal Angiography
Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized.

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaching BP Goal		6 months post-randomization
Primary	Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)		Baseline to 6 months