NCT01881035

Brief Summary

The study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

3.7 years

First QC Date

June 14, 2013

Last Update Submit

March 8, 2021

Conditions

Hypertension Secondary to Renal Disease

Keywords

HypertensionEnd stage renal disease

Outcome Measures

Primary Outcomes (1)

  • Comparison of blood pressures before and after intervention

    2 years

Secondary Outcomes (1)

  • Quality of life

    2 years

Other Outcomes (1)

  • 12-lead ECG changes

    2 years

Study Arms (1)

Renal nerve denervation

EXPERIMENTAL

Renal nerve denervation

Procedure: Renal nerve denervation

Interventions

Renal nerve denervationPROCEDURE

Renal nerve denervation is performed by catheter ablation of renal arteries influencing the sympathetic nerves.

Renal nerve denervation

Eligibility Criteria

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

You may qualify if:

  • patients with end stage renal disease and drug-resistant blood pressure.

You may not qualify if:

  • pregnancy
  • secondary hypertension
  • unstable coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaasa Central Hospital

Vaasa, 65130, Finland

Location

Related Publications (1)

  • Pietila-Effati PM, Salmela AK, Niemi RT, Ylitalo AS, Koistinen MJ. Renal sympathetic denervation in treating drug-resistant hypertension in a patient on hemodialysis. J Hypertens. 2016 Feb;34(2):368-70. doi: 10.1097/HJH.0000000000000802.

    PMID: 26867061DERIVED

MeSH Terms

Conditions

Hypertensive NephropathyHypertensionKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Medicine Turku University

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 19, 2013

Study Start

May 1, 2013

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

FI(1)