Using lower-body negative pressure to improve exercise tolerance in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of lower-body negative pressure (LBNP) on exercise tolerance in patients with heart failure with preserved ejection fraction (HFpEF). The approach aims to reduce venous return during exercise, which may alleviate symptoms of dyspnea and improve overall exercise capacity. Participants will undergo exercise sessions with varying levels of negative pressure applied to the lower body to assess safety and feasibility. The study includes both patients diagnosed with HFpEF and healthy controls for comparison.

Why it matters

Who can join: the full rules

Inclusion Criteria for the HFpEF Group:

* Adults with a clinical diagnosis of HFpEF (LV ejection fraction ≥50%) measured in the year prior to Visit 1 (and confirmed at Visit 1), who are New York Heart Association Functional Class II-III (mild-moderate symptoms), ambulatory, receiving guideline-directed medical therapy unchanged for ≥2 months, and clinically stable for ≥3 months.
* Symptom(s) of heart failure requiring treatment within the year prior to Visit 1
* NT-proBNP \>50 pmol/L (sinus rhythm) or \>150 pmol/L (atrial fibrillation in year prior)
* Diastolic dysfunction based on at least one of the following echocardiographic findings:

  * Left atrial enlargement (diameter \>4 cm or volume index \>28 mL/m2); or
  * e' \<10 cm/s (lateral) or \<8 cm/s (septal), or
  * E/e' \>10 (lateral), or \>15 (septal)

Inclusion Criteria for the Healthy Control Group:

\- Healthy sedentary or recreationally active adults from the community

Exclusion Criteria for the HFpEF Group:

* Any prior measurement demonstrated LV ejection fraction ≤40%
* Primary pulmonary, metabolic, renal, hepatic, neuromuscular, or malignant disease
* Primary pulmonary vascular, complex congenital, or \> mild valvular heart disease
* Documented infiltrative cardiomyopathy
* Documented valvular or coronary disease requiring intervention
* Myocarditis, pericardial effusion, acute coronary syndrome, or revascularization in the last 3 months
* Resting seated systolic blood pressure \>160 mmHg or \<100 mmHg
* Jugular venous pressure \>12 cm
* Inferior vena cava \>2 cm with no inspiratory collapse, or severe right ventricular dysfunction by echo
* Ambulatory supplemental oxygen
* Current or recent participation in \>150 min. per week of moderate intensity exercise
* Current or recent (within the past 6 months) smoking
* Body mass index \>35 kg/m2
* Contraindication to exercise or otherwise unable to perform cycle ergometry
* Poor echocardiographic imaging windows

Exclusion Criteria for the Healthy Control Group

* Current or recent participation in \>150 min. per week of moderate intensity exercise
* History of any cardiovascular condition or cardioactive drug use
* History of any respiratory condition including asthma
* History of any metabolic condition including diabetes
* Non-sinus rhythm
* Echocardiographic evidence of significant left ventricular hypertrophy, valvular abnormalities, left ventricular ejection fraction \<50%, or diastolic dysfunction as described in HFpEF inclusion criteria.
* Seated blood pressure ≥140/90 mmHg
* Any other chronic systemic illness
* Current or recent (within the past 6 months) smoking
* Body mass index \>35 kg/m2
* Contraindication to exercise or otherwise unable to perform cycle ergometry
* Poor echocardiographic imaging windows

Where it's running

• University of British Columbia
  Kelowna, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Neil D Eves, PhD — The University of British Columbia
• Study coordinator: Stephen P Wright, PhD
• Email: stephen.wright@ubc.ca
• Phone: (250) 807-8860

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• EDG-15400 in adults with HFpEF: a phase 2 study

  This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.

  Recruiting at 4 sites Phase 2 Edgewise Therapeutics, Inc. · Birmingham, Alabama and 27 other locations · NCT07795814

• Incretin therapy with tirzepatide for obesity-related HFpEF

  A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

• Boosted exercise with group coaching for HFpEF

  This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07413198

• Exercise cardiac MRI for heart failure with preserved ejection fraction

  This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07401771

• HRS-1893 for heart failure with preserved ejection fraction

  This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.

  Recruiting Phase 2 Shandong Suncadia Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07269717

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.