A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function (RAPID-HELP)
Primary Purpose
Heart Failure, Systolic Dysfunction
Status
Terminated
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Spinal cord stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring spinal cord stimulation, heart failure, autonomic regulation, BNP, left ventricle systolic dysfunction
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Federal North-West Medical Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Spinal cord stimulation on top of standard treatment
Standard treatment
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Exercise capacity as determined by a cardiopulmonary test
Exercise capacity (cardiopulmonary test) baseline, 30 days and 60 days (intervention) Exercise capacity (cardiopulmonary test) baseline, 30 days (control)
Changes in heart failure functional class
Changes in atrial effective refractory period
Number of participants with ventricular arrhythmias
Autonomic regulation tests results change
Tilt-test, Valsalva maneuver, deep breath test
Levels of pro-inflammatory plasma markers
TNF-a, CRP, fibrinogen
Changes in left ventricle ejection fraction as determined by echocardiography
Left ventricle volume
Number of participants with complications
Full Information
NCT ID
NCT02450110
First Posted
May 12, 2015
Last Updated
February 12, 2020
Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
1. Study Identification
Unique Protocol Identification Number
NCT02450110
Brief Title
A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function
Acronym
RAPID-HELP
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
unexpectedly slow recruitment rate
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic Dysfunction
Keywords
spinal cord stimulation, heart failure, autonomic regulation, BNP, left ventricle systolic dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Spinal cord stimulation on top of standard treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard treatment
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation
Primary Outcome Measure Information:
Title
Dynamics of NT-pro-BNP-level
Description
NT-pro-BNP-level baseline, 30 days and 60 days (intervention) NT-pro-BNP-level baseline, 30 days (control)
Time Frame
Baseline, 30, 60 days
Secondary Outcome Measure Information:
Title
Exercise capacity as determined by a cardiopulmonary test
Description
Exercise capacity (cardiopulmonary test) baseline, 30 days and 60 days (intervention) Exercise capacity (cardiopulmonary test) baseline, 30 days (control)
Time Frame
Baseline, 30, 60 days
Title
Changes in heart failure functional class
Time Frame
Baseline, 30, 60 days
Title
Changes in atrial effective refractory period
Time Frame
Baseline, 30, 60 days
Title
Number of participants with ventricular arrhythmias
Time Frame
Baseline, 30, 60 days
Title
Autonomic regulation tests results change
Description
Tilt-test, Valsalva maneuver, deep breath test
Time Frame
Baseline, 30, 60 days
Title
Levels of pro-inflammatory plasma markers
Description
TNF-a, CRP, fibrinogen
Time Frame
Baseline, 30, 60 days
Title
Changes in left ventricle ejection fraction as determined by echocardiography
Time Frame
Baseline, 30, 60 days
Title
Left ventricle volume
Time Frame
Baseline, 30, 60 days
Title
Number of participants with complications
Time Frame
Baseline, 30, 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny V Shlyakhto, MD, DSc
Organizational Affiliation
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal North-West Medical Research Centre
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function
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