NCT02638324

Brief Summary

The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart failure patients. The present study is planned to reduce the sympathetic tone in patients with severe heart failure by renal nervous denervation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable heart-failure

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

4.1 years

First QC Date

May 20, 2015

Last Update Submit

March 9, 2021

Conditions

Heart Failure

Keywords

Renal nervous denervation

Outcome Measures

Primary Outcomes (1)

  • 6-minute walking test

    Composite outcome measure

    24 months

Secondary Outcomes (3)

  • Patient history

    24 months

  • Cardiac echocardiography

    24 months

  • P-proBNP

    24 months

Study Arms (2)

Renal nervous denervation.

ACTIVE COMPARATOR

Renal nervous denervation is performed to the patients who do not response properly to conventional therapy. The patients are randomised according to the waiting list principle.

Procedure: Renal nervous denervation

Renal nervous denervation (delayed)

ACTIVE COMPARATOR

Renal nervous denervation is performed after six months on the waiting list

Procedure: Renal nervous denervation

Interventions

Renal nervous denervationPROCEDURE

The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.

Renal nervous denervation (delayed)Renal nervous denervation.

Eligibility Criteria

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

You may qualify if:

  • NYHA III-IV
  • ejection fraction \<45 %
  • minute walking test under 440m

You may not qualify if:

  • Unstable hemodynamic state
  • uncooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaasa Central Hospital

Vaasa, 65130, Finland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mari-Anne Vaittinen, MD

    Vaasa Central Hospitla

    STUDY CHAIR

  • Mari-Anne Vaittinen, MD

    Vaasa Central Hospital, Vaasa, Finland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

December 23, 2015

Study Start

December 1, 2014

Primary Completion

December 31, 2018

Study Completion

January 30, 2019

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations

FI(1)