Early Phase 1
N=32
Premature Fatigue in Veterans With Heart Failure: Neuronal Influences
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02209610 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Maximal Voluntary Quadriceps Force [% Change From Baseline] — -30; -5 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Electrical and Magnetic Nerve Stimulators (Device); Intrathecal Fentanyl (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Voluntary Quadriceps Force [% Change From Baseline] |
-30; -5 | — |
| PRIMARY Quadriceps Twitch Force and Voluntary Activation (% Change From Baseline) |
-60; -35; -25; -20 | — |
| PRIMARY Muscle Afferent Affect |
-30; 10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- subjects with a history of stable cardiomyopathy (ischemic and non-ischemic, >1yr duration, ages 20-75 yr),
- not pacemaker dependent (no biventricular pacers),
- NYHA class II and III symptoms,
- Left ventricular ejection fraction (LVEF) 50%,
- >1yr duration,
- ages 20-75 yr,
- not pacemaker dependent,
- NYHA class II and III symptoms,
- no or minimal smoking history ( 35), patients with uncontrolled hypertension (>160/100), anemia (Hgb 40 IU/L.
- Women currently taking hormone replacement therapy (HRT) will be excluded from the proposed studies due to the direct vascular effects of HRT.
- Patients with a pacemaker and / or defibrillator will be excluded from the study due to the use of a magnetic/electric stimulators.
Data sourced from ClinicalTrials.gov (NCT02209610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.