NCT02450110

Brief Summary

A randomized pilot study of spinal cord stimulation in patients with chronic heart failure aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Feb 2015

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

May 12, 2015

Last Update Submit

February 12, 2020

Conditions

Heart FailureSystolic Dysfunction

Keywords

spinal cord stimulationheart failureautonomic regulationBNPleft ventricle systolic dysfunction

Outcome Measures

Primary Outcomes (1)

  • Dynamics of NT-pro-BNP-level

    NT-pro-BNP-level baseline, 30 days and 60 days (intervention) NT-pro-BNP-level baseline, 30 days (control)

    Baseline, 30, 60 days

Secondary Outcomes (9)

  • Exercise capacity as determined by a cardiopulmonary test

    Baseline, 30, 60 days

  • Changes in heart failure functional class

    Baseline, 30, 60 days

  • Changes in atrial effective refractory period

    Baseline, 30, 60 days

  • Number of participants with ventricular arrhythmias

    Baseline, 30, 60 days

  • Autonomic regulation tests results change

    Baseline, 30, 60 days

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Spinal cord stimulation on top of standard treatment

Device: Spinal cord stimulation

Control

NO INTERVENTION

Standard treatment

Interventions

Spinal cord stimulationDEVICE
Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic heart failure II-III class (NYHA);
  • Age 18-70 years;
  • Left ventricle ejection fraction ≤35%;
  • Optimal heart failure management according to the guidelines;
  • Signed informed consent

You may not qualify if:

  • Heart transplant list;
  • Acute conditions, including systemic infection;
  • Reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc);
  • Planned elective heart surgery or intervention;
  • Recent (3 months) myocardial infarction, coronary intervention;
  • Heart failure decompensation;
  • Implanted cardiac resynchronization device \< 6 months ago;
  • Contraindications for lumbal puncture or placement of a spinal cord pacing electrode;
  • Permanent atrial fibrillation;
  • Stroke or TIA \< 6 months ago;
  • Pulmonary thromboembolist \< 3 months ago;
  • Hypertrophic cardiomyopathy with obstruction;
  • Angina III-IV class, or congestive heart failure IV class;
  • Participation in any other clinical trial;
  • Women of childbearing possibility without appropriate contraception, pregnant, or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal North-West Medical Research Centre

Saint Petersburg, 197341, Russia

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Evgeny V Shlyakhto, MD, DSc

    Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 21, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations

RU(1)