Clinical trial NCT05288387: Spinal Cord Stimulation in Hypotensive Heart Failure Patients: Hemodynamic Assessment
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Systolic blood pressure elevation
timeFrame: 10 minutes
Secondary outcomes:
measure: Systemic vascular resistance elevation
timeFrame: 10 minutes
measure: Pulmonary vascular resistance change
timeFrame: 10 minutes
measure: Pulmonary capillary wedge pressure change
timeFrame: 10 minutes
measure: Pulmonary artery pressure change
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
Study officials:
affiliation: Almazov National Medical Research Centre
name: Evgeny N Mikhaylov, Assoc.prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.