RECRUITING

PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction

Talk to us

Conditions

Heart Failure With Reduced Ejection FractionHFrEFVO2peak

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).

Official Title

PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction

Quick Facts

Study Start:2023-04-14
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05609097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  2. * Subjects may be of either sex with age \> 65 years.
  3. * Subjects must be diagnosed with HFrEF as per established echocardiographic criteria (New York Heart Association Class II-III) with an ejection fraction \<40%.
  4. * Cardiologist approve after thorough chart review and physical examination
  5. * Hemoglobin of at least 10.0 g/dL
  1. * Progressive worsening of exercise tolerance or dyspnea at rest or on exertion over previous 3-5 days
  2. * Significant ischemia at low exercise intensities (\<2 METS or \~50 W)
  3. * Uncontrolled diabetes (HbA1c \>10%)
  4. * Acute systemic illness of fever
  5. * Recent embolism (in the 6 weeks)
  6. * Deep Vein Thrombophlebitis
  7. * Active pericarditis or myocarditis
  8. * Severe aortic stenosis (aortic valve area \<1.0 cm2)
  9. * Regurgitant valvular heart disease requiring surgery
  10. * Myocardial infarction within previous 3 weeks
  11. * New onset atrial fibrillation (in the last 4 weeks)
  12. * Resting Heart Rate \>120bpm

Contacts and Locations

Study Contact

Emily Planas, B.S
CONTACT
434-243-8677
ejg9rb@virginia.edu

Principal Investigator

Jason Allen, PhD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of Virginia, Department of Kinesiology
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Jason Allen, PhD, PRINCIPAL_INVESTIGATOR, University of Virginia

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

Study Start Date2023-04-14
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2023-04-14
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • HFrEF
  • VO2peak

Additional Relevant MeSH Terms

  • Heart Failure With Reduced Ejection Fraction