CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 32 enrolled
Drug / intervention
Intrathecal Fentanyl +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02209610
NCT02209610Early Ph 1Completed

Premature Fatigue in Veterans With Heart Failure: Neuronal Influences

VA Office of Research and Development·interventional·Posted Aug 6, 2014·Updated Aug 2, 2019

In Brief

A Early Phase 1 clinical trial evaluating Electrical and Magnetic Nerve Stimulators and Intrathecal Fentanyl for Heart Failure. Completed, enrolled 32 participants across 1 site.

Detailed Summary

A hallmark of patients with heart failure (HF) is premature fatigue which impairs their quality of life and depicts a major source of morbidity. Premature fatigue may be attributed to a) contraction-induced transient changes within muscles (i.e. peripheral fatigue) and/or b) failure of the central nervous system to 'drive' / activate locomotor muscles (i.e. central fatigue). Both determinants of fatigue can lead to a reduction in a muscle's force and power generating capacity and to a compromised ability to perform whole body activities (e.g. walking). Recent findings in health have documented that group III/IV afferent fibers from the working muscle play a critical role in the development of both components of fatigue. Specifically, group III/IV muscle afferents limit central motor drive (CMD) during exercise and thereby exaggerate the development of central fatigue. In contrast, muscle afferents optimize muscle O2 delivery through the precise regulation of circulation and ventilation during exercise and thereby attenuate the development of peripheral fatigue.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsUniversity of Utah

Timeline

Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 6, 2014
Enrollment StartJul 1, 2015
Primary CompletionJan 15, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.9 years ago

Interventions

Electrical and Magnetic Nerve Stimulatorsdevice

Stimulation of motor nerve and central nervous system

Intrathecal Fentanyldrug

Mu-opioid receptor agonist