RECRUITING

Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction

Talk to us

Conditions

Heart Failure With Preserved Ejection Fraction

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

The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF.

Official Title

Leg Heat Therapy to Improve Functional Performance in Heart Failure With Preserved Ejection Fraction (HFpEF)

Quick Facts

Study Start:2024-05-28
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06388226

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women older than 18 years
  2. * Established diagnosis of heart failure with preserved ejection fraction (HFpEF) including left ventricular ejection fraction (LVEF) ≥50% as evidenced by Doppler echocardiography and/or ratio of the early mitral inflow velocity (E) to septal tissue Doppler velocity (e') \>8 and at least 1 other sign of chronically elevated filling pressures, including an enlarged left atrium (left atrial volume index \>34 mL/m2), an elevated N-terminal pro-brain natriuretic peptide (NT-pro-BNP) level within the past year, long-term loop diuretic use for control of symptoms, or elevated filling pressures (mean pulmonary capillary wedge pressure \>12 mmHg) on prior cardiac catheterization
  3. * Stable medical treatment
  1. * Recent hospitalization (within the previous 1 month)
  2. * Unstable angina and/or uncontrolled cardiac arrhythmia causing symptoms or hemodynamic compromise (including severe bradycardia or tachycardia, sick sinus syndrome, or multifocal premature ventricular contractions)
  3. * Presence of any clinical condition that makes the patient unsuitable to participate in the trial, e.g., significant ischemic or valvular heart disease, cor pulmonale, unstable coronary artery disease, primary renal (e.g., estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73 m2) or hepatic disease (e.g., aspartate aminotransferase and alanine aminotransferase levels \>3.0 times the upper limit of the normal range), pulmonary, neuromuscular, orthopedic disorders, among others
  4. * Inability to exercise on the treadmill
  5. * Inability to provide informed consent
  6. * Concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse)
  7. * Any contraindication to heat therapy and/or inability to fit into water-circulating trousers
  8. * Impaired thermal sensation in the leg

Contacts and Locations

Study Contact

Doris Muriathiri, MPH, CCRP
CONTACT
317-274-0903
dmuriath@iu.edu
Daniel Hirai, PhD
CONTACT
765-494-7113
dhirai@purdue.edu

Study Locations (Sites)

IU Health Methodist
Indianapolis, Indiana, 46202
United States
IU Health University Hospital
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

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 Date2024-05-28
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2024-05-28
Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure With Preserved Ejection Fraction