NCT01834118

Brief Summary

The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

2.8 years

First QC Date

April 15, 2013

Last Update Submit

July 27, 2016

Conditions

Hypertension, Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (1)

  • Office Blood pressure measurement

    up to1 year

Interventions

Renal DenervationPROCEDURE

Sympathetic nerve ablation via transcatheter renal denervation

Also known as: Renal sympathetic nerve ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with treatment-resistant hypertension, who already underwent renal denervation with no therapeutic avail.

You may qualify if:

  • Individual is ≥18 years old
  • Individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.
  • Systolic Office based blood pressure ≥140mmHg
  • Individual receives 3 or more antihypertensive drugs including one diuretic
  • Individual is willing to provide written informed consent to participate in this study

You may not qualify if:

  • Individual has hypertension secondary to an identifiable and treatable cause
  • Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.
  • Individual is pregnant, nursing or planning to be pregnant
  • Renal artery abnormalities which may affect the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CardioVascular Center Frankfurt

Frankfurt am Main, Hesse, 60389, Germany

Location

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Officials

  • Horst Sievert, M.D.

    Cardiovascular Center Frankfurt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 17, 2013

Study Start

June 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

DE(1)