A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function

Heart Failure Clinical Trial

— RAPID-HELP  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02450110
• Other study ID #: RAPID-HELP
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 2017

Study information

• Verified date: February 2020
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Systolic Dysfunction

Intervention

Device:
• Spinal cord stimulation

Locations

Country	Name	City	State
Russian Federation	Federal North-West Medical Research Centre	Saint-Petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Baseline, 30, 60 days
Secondary	Changes in heart failure functional class		Baseline, 30, 60 days
Secondary	Changes in atrial effective refractory period		Baseline, 30, 60 days
Secondary	Number of participants with ventricular arrhythmias		Baseline, 30, 60 days
Secondary	Autonomic regulation tests results change	Tilt-test, Valsalva maneuver, deep breath test	Baseline, 30, 60 days
Secondary	Levels of pro-inflammatory plasma markers	TNF-a, CRP, fibrinogen	Baseline, 30, 60 days
Secondary	Changes in left ventricle ejection fraction as determined by echocardiography		Baseline, 30, 60 days
Secondary	Left ventricle volume		Baseline, 30, 60 days
Secondary	Number of participants with complications		Baseline, 30, 60 days