NCT00753285

Brief Summary

The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

4.7 years

First QC Date

September 12, 2008

Last Update Submit

November 3, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.

    Through 3 years

Secondary Outcomes (1)

  • Physiologic response to renal denervation (e.g., blood pressure reduction)

    Through 3 years

Study Arms (1)

Renal Denervation

EXPERIMENTAL
Device: Renal Denervation

Interventions

Renal DenervationDEVICE
Also known as: Symplicity Renal Denervation System
Renal Denervation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systolic blood pressure of 160 mmHg or greater
  • On 3 or more antihypertensive medications
  • eGFR \>= 45 mL/min

You may not qualify if:

  • Renal artery abnormalities
  • Known secondary hypertension attributable to a cause other than sleep apnea
  • MI, angina, CVA within 6 months
  • Type 1 diabetes
  • Others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Prairie Heart Institute

Springfield, Illinois, 62701, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (1)

  • Krum H, Schlaich MP, Sobotka PA, Bohm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7.

    PMID: 24210779DERIVED

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Henry Krum, PhD

    Monash University and the Alfred Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 16, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

US(3)