A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function (RAPID-HELP)

February 12, 2020 updated by: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized (1:1) for spinal cord stimulation as an addition to optimal guidelines-driven management or to control group on optimal management only. Spinal cord stimulation will be performed for 30 days, and outcome measures will be testes before stimulation, after 30 days stimulation and after 30 days of further follow-up. The control group will be studied at baseline and after 30 days only.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Saint-Petersburg, Russian Federation, 197341
        • Federal North-West Medical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard treatment
Experimental: Intervention
Spinal cord stimulation on top of standard treatment
Device: Spinal cord stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamics of NT-pro-BNP-level
Time Frame: Baseline, 30, 60 days
NT-pro-BNP-level baseline, 30 days and 60 days (intervention) NT-pro-BNP-level baseline, 30 days (control)
Baseline, 30, 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise capacity as determined by a cardiopulmonary test
Time Frame: Baseline, 30, 60 days
Exercise capacity (cardiopulmonary test) baseline, 30 days and 60 days (intervention) Exercise capacity (cardiopulmonary test) baseline, 30 days (control)
Baseline, 30, 60 days
Changes in heart failure functional class
Time Frame: Baseline, 30, 60 days
Baseline, 30, 60 days
Changes in atrial effective refractory period
Time Frame: Baseline, 30, 60 days
Baseline, 30, 60 days
Number of participants with ventricular arrhythmias
Time Frame: Baseline, 30, 60 days
Baseline, 30, 60 days
Autonomic regulation tests results change
Time Frame: Baseline, 30, 60 days
Tilt-test, Valsalva maneuver, deep breath test
Baseline, 30, 60 days
Levels of pro-inflammatory plasma markers
Time Frame: Baseline, 30, 60 days
TNF-a, CRP, fibrinogen
Baseline, 30, 60 days
Changes in left ventricle ejection fraction as determined by echocardiography
Time Frame: Baseline, 30, 60 days
Baseline, 30, 60 days
Left ventricle volume
Time Frame: Baseline, 30, 60 days
Baseline, 30, 60 days
Number of participants with complications
Time Frame: Baseline, 30, 60 days
Baseline, 30, 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Evgeny V Shlyakhto, MD, DSc, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAPID-HELP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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