Exercise and NO in HFrEF
Heart disease is the leading cause of death in the United States, accounting for one in every four deaths in 2010 and costing over $300 billion annually in health care, medication, and lost productivity. Heart failure with a reduced ejection fraction (HFrEF), a clinical syndrome that develops as a consequence of heart disease, now affects almost 6 million Americans. Within the VA Health Care System, HFrEF hospital admission rates continue to rise, and remain the number one reason for discharge from VA hospitals nationwide. Unfortunately, over one-third of all Veterans suffering from HFrEF die within two years of discharge despite optimized drug therapy, an unacceptably high number. This proposal is focused on how impaired muscle blood flow contributes to exercise intolerance in HFrEF, and on subsequently developing strategies for restoring exercise tolerance and slowing disease progression in this patient group. It is anticipated that knowledge gained from these studies will contribute to improved standard of care, quality of life, and prognosis in this VA patient group.
Conditions:
🦠 Heart Failure With Reduced Ejection Fraction
🗓️ Study Start (Actual) 1 June 2018
🗓️ Primary Completion (Estimated) 31 May 2025
✅ Study Completion (Estimated) 31 May 2026
👥 Enrollment (Estimated) 140
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Salt Lake City, Utah, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

      Exclusion Criteria:

      • * The study group will include subjects with a history of stable cardiomyopathy (ischemic and non-ischemic, \>3 months duration, ages 45-75 yrs) despite a minimum of 6 weeks of optimal treatment.
      • * Optimal therapy will be according to American Heart Association (AHA) /American College of Cardiology (ACC) and Heart Failure Society of America (HFSA) HF guidelines, including treatment with angiotensin-converting enzyme (ACE) and -blocker therapy (for at least 6 weeks), or have documented reason for variation, including medication intolerance, contraindication, patient preference, or personal physician's judgment.
      • * Patient enrollment will be limited to those individuals with New York Heart Association (NYHA) class II and III symptoms, left ventricular ejection fraction \<35% (LVEF), with no or minimal smoking history (\<15 pk yrs), and without pacemakers.
      • * Patients with atrial fibrillation or HF believed to be secondary to atrial fibrillation will be excluded.
      • * Patients with HF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction) will also 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.
      • * Patients must have no orthopedic limitations that would prohibit them from performing knee-extensor exercise.
      • * Due to the typical age of patients with HF, 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.
      • * These include a diagnosis of Dementia
      • * Severe chronic obstructive pulmonary disease (COPD)
      • * Peripheral Vascular Disease
      • * Anemia
      • * Sleep-related Breathing Disorder
      • * Severe Valvular Heart Disease
      • * Diabetes (if on insulin therapy)
      • * or End-stage Malignancy
      • * The investigators will also exclude morbidly obese patients (BMI \>40), patients with uncontrolled Hypertension (\>160/100), Anemia (Hgb\<9) and Severe Renal Insufficiency (individuals with creatinine clearance \<30 by the Cockcroft-Gault formula).
    Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
    Sexes Eligible for Study: ALL
    Accepts Healthy Volunteers: No

    🗓️ Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates

    • First Submitted 27 April 2017
    • First Submitted that Met QC Criteria 27 April 2017
    • First Posted 2 May 2017

    Study Record Updates

    • Last Update Submitted that Met QC Criteria 26 June 2024
    • Last Update Posted 27 June 2024
    • Last Verified June 2024