Status:
TERMINATED
Spinal Cord Stimulation in Hypotensive Heart Failure Patients: Hemodynamic Assessment
Lead Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Conditions:
Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
NA
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 c...
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 h...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Hypovolemic status (central venous pressure \<2 mm Hg).
- Any acute illness.
- Transient ischemic event or stroke within 2 weeks prior to inclusion.
- 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.
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05288387
Start Date
March 25 2022
End Date
January 9 2024
Last Update
March 6 2024
Active Locations (1)
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1
Almazov National Medical Research Centre
Saint Petersburg, Russia, 197341