High Altitude Training And Lower Limb Heating Training In Heart Failure

Overview

About this study

The purpose of this study is to evaluate whether intermittent simulated high altitude, lower limb heating or a combination improves oxygen transport and utilization in in heart failure patients with reduced and preserved ejection fraction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Completed HF rehabilitation (i.e., physically capable to perform exercise) and referred to HF service. That is: Individuals with heart failure who are aged over 18 years, a confirmed diagnosis of HF as per the National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand HF guidelines1, clinically stable and deemed suitable to participate in an exercise program, and New York Heart Association functional classification I to II.

  • NYHA class I-II, heart failure with reduced HFrEF and preserved ejection fraction (HFpEF)

  • Aged ≥ 18 years

  • No exacerbations of HF-related symptoms or changes in medications within the past 3 months.

  • Free from unstable angina, recent myocardial infarction or severe valvular disease.

  • No skin conditions that would prevent limb immersion in water bath.

  • No contraindications or increased risks for undertaking exercise tests (see below) as per standard guidelines9

    • Contraindications for exercise testing

      • Early phase after acute coronary syndrome (up to 2 days)

      • Untreated life-threatening cardiac arrhythmias

      • Acute heart failure (during the initial period of haemodynamic instability)

      • Uncontrolled hypertension

      • Advanced atrioventricular block

      • Acute myocarditis and pericarditis

      • Symptomatic aortic stenosis

      • Severe hypertrophic obstructive cardiomyopathy

      • Acute systemic illness

      • Intracardiac thrombus

      • Progressive worsening of exercise tolerance or dyspnoea at rest over previous 3–5 days

      • Significant ischaemia during low-intensity exercise (<2 METs, <50 W)

      • Uncontrolled diabetes

      • Recent embolism

      • Thrombophlebitis

      • New-onset atrial fibrillation/atrial flutter

    • Increased risk for exercise testing

      • >1.8 kg increase in body mass over the previous 1 – 3 days

      • Concurrent, continuous, or intermittent dobutamine therapy

      • Decrease in systolic blood pressure with exercise

      • Complex ventricular arrhythmia at rest or appearing with exertion

      • Supine resting heart rate >100 bpm

      • Pre-existing co-morbidities limiting exercise tolerance.

Exclusion Criteria:

  • Participants who have not been referred/participated in HF rehabilitation

  • NYHA class III and IV

  • Participants younger than 18 years

  • Participants with exacerbation of HF symptoms or changes in medications within the past 3 months

  • HF participants with unstable angina, recent myocardial infarction or severe valvular disease

  • HF participants with skin conditions that would prevent limb immersion in water bath.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/23/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bruce Johnson

Contact us for the latest status

Contact information:

Jessica Johnston

(507) 266-2696

Johnston.Jessica1@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20597291

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