Spinal Cord Stimulation in Hypotensive Heart Failure Patients: Hemodynamic Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-25

Study Completion Date

2024-01-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Spinal cord stimulation in heart failure patients with hypotension

Adhesive patches are applied to subjects' back skin. Single stimuli are delivered in order to define the stimulation threshold under the guidance of neuromyography. Vascular access is performed (jugular or subclavian) according to conventional preparation to right heart catheterization. Invasive hemodynamic measures are performed as usual.

High-frequency spinal cord stimulation at T5 level is initiated, and repeated hemodynamic measures performed within 2 minutes. Stimulation lasts for 5-10 minutes, and then ceased. Following a 5-minutes waiting period, repeat hemodynamic measures are performed. The same sequence of steps applies for stimulation levels T7-8 and a combination of T5 and T7-8.

Then the procedure is completed and data are analysed.

Group Type EXPERIMENTAL

Spinal cord stimulation

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No