Spinal Cord Stimulation in Hypotensive Heart Failure Patients: Hemodynamic Assessment

Heart Failure Clinical Trial

Official title:

Hemodynamic Effects of Transcutaneous Spinal Cord Stimulation in Patients With Chronic Heart Failure Undergoing Right Heart Catheterization for the Inclusion Into the Heart Transplantation Program: a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05288387
• Other study ID #: HF-SCS-2022
• Status: Terminated
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: January 9, 2024

Study information

• Verified date: January 2022
• 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

This is a prospective single-center study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation on systemic and pulmonary hemodynamics, assessed during right heart catheterization in patients with heart failure and persistent or transient hypotension subjected to be included into the heart transplantation waiting list.

Description:

The study aims to assess hemodynamic effects of non-invasive transcutaneous spinal cord stimulation during invasive hemodynamics evaluation in patients with heart failure and transient or persistent hypotension undergoing catheterization before inclusion into the heart transplantation program. Eligible patients will sign an informed consent form before the procedure. Non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using high-frequency modulated electrical impulses through adhesive electrodes attached to the back skin. The stimulation protocol includes analysis of the following parameters: heart rate; electrocardiogram in 12 leads; invasive blood pressure; pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac input, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, pulmonary vascular resistance.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years.

2. Patients with heart failure III-IV functional class (NYHA) with indications to right heart catheterization.

3. Systolic blood pressure <110/70 mm Hg when measured while sitting.

4. Patient who signed an informed consent form.

Exclusion Criteria:

1. Hypovolemic status (central venous pressure <2 mm Hg).

2. Any acute illness.

3. Transient ischemic event or stroke within 2 weeks prior to inclusion.

4. Pulmonary embolism <1 month ago.

5. Epilepsy.

6. An implanted infusion pump.

7. Pacemaker-dependent patients.

8. Patients who have contraindications to the use of the patch electrodes used in this study, as indicated in the respective instructions for use.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Spinal cord stimulation
High-frequency stimulation with modulated current via skin patches captures posterior horns of the spinal cord and this activation leads to blood pressure elevation.

Locations

Country	Name	City	State
Russian Federation	Almazov National 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, 

References & Publications (1)

Mikhaylov EN, Moshonkina TR, Zharova EN, Garkina SV, Kovzelev PD, Belyaeva NN, Kozlenok AV, Lebedev DS, Shlyakhto EV. Acute Cardiovascular Effects of Non-Invasive Electrical Spinal Cord Stimulation: Results from a Pilot Study in Humans. J Cardiovasc Transl Res. 2020 Dec;13(6):891-893. doi: 10.1007/s12265-020-10014-7. Epub 2020 May 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure elevation	It is suggested that spinal cord stimulation will elevate averaged systolic blood pressure by >5 mmHg within 10 minutes, as compared to tilt testing without stimulation, and as measured invasively through a vascular catheter. Number of participants with increase in systolic blood pressure by more than 5 mmHg within 10 minutes will be counted. The achievement of the primary outcome will be considered if >50% of patients will have an increase in systolic blood pressure.	10 minutes
Secondary	Systemic vascular resistance elevation	It is suggested that spinal cord stimulation will elevate systemic vascular resistance by 10 percent (estimated using the standard equation method based on invasive hemodynamic measurements). Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated.	10 minutes
Secondary	Pulmonary vascular resistance change	A statistically detectable decrease in pulmonary vascular resistance in the patient group based on invasive hemodynamic measurements, and estimated using the standard equation method based on invasive hemodynamic measurements. Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated.	10 minutes
Secondary	Pulmonary capillary wedge pressure change	A statistically detectable change in pulmonary capillary wedge pressure in the patient group based on invasive measurements. Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated.	10 minutes
Secondary	Pulmonary artery pressure change	A statistically detectable change in pulmonary artery systolic, diastolic, or mean pressure in the patient group based on invasive measurements. Hemodynamic measures are performed using a hemodynamic catheter. This is a physiological parameter. Number of patients with change >10 percent will be calculated.	10 minutes