Status:
COMPLETED
Premature Fatigue in Veterans With Heart Failure: Neuronal Influences
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Utah
Conditions:
Heart Failure
Eligibility:
All Genders
20-75 years
Phase:
EARLY_PHASE1
Brief 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-i...
Detailed Description
Recent findings in HF suggest an altered effect of group III/IV muscle afferents in this population. Although normal afferent feedback is crucial for adequate O2 delivery during exercise, excessive ne...
Eligibility Criteria
Inclusion
- 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)\<35%,
- no or minimal smoking history (\<15 pk yrs) and on stable medications.
- The investigators will also study subjects with preserved ejection fraction
- heart failure with a preserved ejection fraction (HFpEF);
- LVEF \>50%,
- \>1yr duration,
- ages 20-75 yr,
- not pacemaker dependent,
- NYHA class II and III symptoms,
- no or minimal smoking history (\<15 pk yrs) and on stable medications. The investigators will exclude morbidly obese patients (BMI \>35), patients with uncontrolled hypertension (\>160/100), anemia (Hgb\<9) and severe renal insufficiency (individuals with creatinine clearance \<30 by the Cockcroft-Gault formula).
Exclusion
- Patients with significant non-cardiac comorbidities, which if present could alter the study results, will be excluded.
- Patients will be sedentary, defined here as no regular physical activity for at least the prior 6 months and current activity level will be documented by an activity questionnaire.
- Candidates must have no orthopedic limitations that would prohibit them from performing exercise.
- Due to the typical age of patients with heart failure, all women will be postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years,
- and in women without a uterus, follicle stimulating hormone (FSH) \>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.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02209610
Start Date
July 1 2015
End Date
January 15 2017
Last Update
August 2 2019
Active Locations (1)
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1
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148