NCT01538992

Brief Summary

Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_3 heart-failure

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 16, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

9 months

First QC Date

February 16, 2012

Last Update Submit

July 23, 2013

Conditions

Heart Failure

Keywords

renal denervationheart failure

Outcome Measures

Primary Outcomes (1)

  • Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events

    6 months

Secondary Outcomes (1)

  • • Ventricular function as measured by Echocardiography • NYHA functional Class, 6 min walking test, biochemical test. • Renal function as measured by Glomerular Filtration Rate (GFR)

    6 months

Study Arms (2)

renal denervation

EXPERIMENTAL

in this group percutaneous renal denervation with Standard steerable Mariner Radiofreqency ablation Catheter (5F or 7F)

Device: Standard steerable Marinr RF ablation Catheter (5F or 7F)

medical thrapy

NO INTERVENTION

medical treatment

Interventions

Standard steerable Marinr RF ablation Catheter (5F or 7F)DEVICE

Intervention: Device: Standard steerable Mariner Radiofrequency ablation Catheter (5F or 7F)

Also known as: Renal ablation
renal denervation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart Failure patients NYHA Class III or IV
  • Left Ventricular Ejection Function \< 35%
  • GFR \> 45 mL/min/1.73m2
  • Optimal stable medical therapy

You may not qualify if:

  • Do not eligible renal artery anatomy for treatment as determined by Angiography, and
  • History of prior renal artery intervention
  • Single functioning kidney.
  • Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
  • Systolic BP \< 110mmHG Hospitalisation because of heart failure in last 3 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • HASAN ARI, MD

    Bursa Postgraduate Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Cardiology Chief Intern

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 27, 2012

Study Start

April 1, 2013

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

TU(1)