NCT05288387

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

March 25, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2024

Completed
Last Updated

March 6, 2024

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

January 28, 2022

Last Update Submit

March 4, 2024

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Systemic vascular resistance elevation

    10 minutes

  • Pulmonary vascular resistance change

    10 minutes

  • Pulmonary capillary wedge pressure change

    10 minutes

  • Pulmonary artery pressure change

    10 minutes

Study Arms (1)

Spinal cord stimulation in heart failure patients with hypotension

EXPERIMENTAL

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.

Procedure: Spinal cord stimulation

Interventions

Spinal cord stimulationPROCEDURE

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

Spinal cord stimulation in heart failure patients with hypotension

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years.
  • Patients with heart failure III-IV functional class (NYHA) with indications to right heart catheterization.
  • Systolic blood pressure \<110/70 mm Hg when measured while sitting.
  • Patient who signed an informed consent form.

You may not qualify if:

  • Hypovolemic status (central venous pressure \<2 mm Hg).
  • Any acute illness.
  • Pulmonary embolism \<1 month ago.
  • Epilepsy.
  • An implanted infusion pump.
  • Pacemaker-dependent patients.
  • Patients who have contraindications to the use of the patch electrodes used in this study, as indicated in the respective instructions for use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location

Related 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.

    PMID: 32378161BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Evgeny N Mikhaylov, Assoc.prof.

    Almazov National Medical Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

March 21, 2022

Study Start

March 25, 2022

Primary Completion

January 9, 2024

Study Completion

January 9, 2024

Last Updated

March 6, 2024

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Data sharing will be discussed during regular meetings of the study and supervising committees after enrollment of at least 30% of subjects.

Locations

RU(1)