NCT03970551: IOH

Lower Body Muscle Pre-activation in Initial Orthostatic Hypotension

Status unknown NA Last updated 29 April 2021

What this trial tests

NA trial testing Physical Counter-maneuver in Orthostatic Intolerance in 64 participants. Status unknown.

Timeline

1 July 2019

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	1 July 2019
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Canada

Drugs / interventions tested

• Physical Counter-maneuver
• Stress Test
• Functional Electrical Stimulation

Conditions studied

• Orthostatic Intolerance — all drugs for Orthostatic Intolerance →
• Syncope — all drugs for Syncope →
• Fainting — all drugs for Fainting →
• Presyncope — all drugs for Presyncope →

Sponsor

University of Calgary

Who can join

Adults 18 to 50, any sex, with Orthostatic Intolerance or Syncope. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is aimed primarily at providing a simple and effective form of treatment to reduce the symptoms of Initial Orthostatic Hypotension (IOH) and prevent syncope. We will first characterize the physiology of IOH, and then we will study four sit-to-stand maneuvers, each with a different stress tests to identify the role of sympathetic activity vs. simple muscle contraction in IOH. Then we will complete an additional two sit-to-stands with interventions designed to decrease the blood pressure drop (and hopefully symptoms) with initial stand. These consist of physical counter maneuvers, which may be a possible treatment that can be used to mitigate the drop in blood pressure (BP) seen in IOH during a stand and relieve presyncope symptoms.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mitigating Initial Orthostatic Hypotension: Mechanistic Roles of Muscle Contraction Versus Sympathetic Activation.
   Sheikh NA, Phillips AA, Ranada S, Lloyd M, et al · · 2022 · cited 11× · PMID 34990207 · DOI 10.1161/hypertensionaha.121.18580