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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01919918
Other study ID # 62914
Secondary ID
Status Completed
Phase Phase 1
First received July 29, 2013
Last updated January 4, 2018
Start date September 2013
Est. completion date January 3, 2018

Study information

Verified date January 2018
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to find out more about the mechanism by which neural feedback from the working muscle affects the development of central fatigue during exercise. Subjects with chronic heart failure (HF) and healthy subject counterparts will be tested to determine the mechanisms accounting for the premature fatigue characterizing HF patients during physical activity.


Description:

A substantial part in limiting exercise and/or physical activity in humans results from the development of peripheral and central fatigue during physical activity. Peripheral fatigue comprises biochemical changes within the metabolic milieu of the working muscle leading to an attenuated response to neural excitation, while central fatigue comprises a failure of the central nervous system to drive motoneurons.

Patients with HF have overactive group III/IV muscle afferents and an exaggerated development of central fatigue during physical activity that is not explained by their reduced physical conditioning or cardiac insufficiency caused by their failing heart. The exact mechanisms accounting for the exaggerated central fatigue in HF remains elusive, however, the development of central fatigue during exercise has recently been linked to signaling by group III/IV muscle afferents. This makes the heightened neural feedback in HF a likely candidate for these patients' increased susceptibility to central fatigue.

Lower pH, increased lactate and increased adenosine triphosphate has been shown to activate group III/IV afferents in a physiological manner and thus induce, in a rested and unfatigued muscle, the intramuscular milieu associated with moderate to heavy exercise. The objective of this study is to quantitate and compare the sensitivity of group III/IV afferents and associated effects on central fatigue in HF patients and healthy controls when skeletal muscle is subject to controlled lower pH, increased lactate and increased adenosine triphosphate.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date January 3, 2018
Est. primary completion date January 3, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 79 Years
Eligibility Heart Failure Inclusion Criteria:

- Subjects with a history of stable cardiomyopathy (ischemic and non-ischemic, greater than 1 year duration, ages 20-79 years)

- New York Heart Association class I through IV symptoms

- Left ventricular ejection fraction less than 35 percent (heart failure patients with reduced left ventricular ejection fraction) or greater than 50 percent (heart failure patients with preserved left ventricular ejection fraction)

- Sedentary, no regular physical activity for at least 6 months prior

- Post-menopausal for at least 2 years and follicle stimulating hormone greater than 40

Heart Failure Exclusion Criteria:

- Patients with atrial fibrillation or heart failure believed to be secondary to atrial fibrillation

- Morbidly obese patients with a body mass index greater than 35

- Patients with uncontrolled hypertension, greater than 160/100

- Anemia with a hemoglobin less than 9

- Severe renal insufficiency (creatinine clearance less than 30 by the Cockcroft-Gault formula)

- Patients with significant non-cardiac comorbidities

- Orthopedic limitations that would prohibit them from performing the elbow-flexor exercise

- Current smoker or smoking history of 15 packs or more per year

- Women currently taking hormone replacement therapy

Healthy Control Inclusion Criteria:

- Ages 20-75 years

- Sedentary, no regular physical activity for at least 6 months prior

- Post-menopausal for at least 2 years and follicle stimulating hormone greater than 40

Healthy Control Exclusion Criteria:

- History of cardiovascular related abnormalities or pulmonary abnormalities

- Morbidly obese patients with a body mass index greater than 35

- Patients with uncontrolled hypertension, greater than 160/100

- Anemia with a hemoglobin less than 9

- Orthopedic limitations that would prohibit them from performing the elbow-flexor exercise

- Current smoker or smoking history of 15 packs or more per year

- Women currently taking hormone replacement therapy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Muscle Contraction with Metabolite Solution Administration
Participants will perform maximal elbow flexor or knee extensor contractions before and after administration of metabolite solutions of pH 7.2, pH 7.0 and pH 6.6

Locations

Country Name City State
United States George E Wahlen Vetern Affairs Medical Center Salt Lake City Utah
United States Veterans Affairs Salt Lake City Heath Care System Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Elbow Flexor Maximal Voluntary Contraction in newton-meters 2 minutes
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