Muscle Afferent Feedback Effects in Patients With Heart Failure

NCT01919918 | Completed Phase 1 DMC

• 1 other identifier: 62914
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Elbow Flexor Maximal Voluntary Contraction in newton-meters

  2 minutes

Study Arms (2)

Heart Failure Patients

OTHER

Patients with heart failure will undergo intervention of muscle contraction with metabolite solution administration. Maximal voluntary muscle contraction exercise with varying metabolite solution administration of adenosine triphosphate, lactate, and protons with phosphate buffer.

Drug: Muscle Contraction with Metabolite Solution Administration

Control Participants

OTHER

Healthy control participants will undergo intervention of muscle contraction with metabolite solution administration. Maximal voluntary muscle contraction exercise with varying metabolite solution administration of adenosine triphosphate, lactate, and protons with phosphate buffer.

Drug: Muscle Contraction with Metabolite Solution Administration

Interventions

Muscle Contraction with Metabolite Solution Administration DRUG

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

Also known as: adenosine triphosphate, lactate, and protons with phosphate buffer

Control Participants; Heart Failure Patients

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

George E Wahlen Vetern Affairs Medical Center

Salt Lake City, Utah, 84148, United States

Location

Veterans Affairs Salt Lake City Heath Care System

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Interventions

Muscle Contraction; Adenosine Triphosphate; Lactic Acid; Protons

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Markus Amann, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 9, 2013
• Study Start: September 1, 2013
• Primary Completion: January 3, 2018
• Study Completion: January 3, 2018
• Last Updated: January 8, 2018

Record last verified: 2018-01

Locations

US (2)