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Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure

NCT05223751 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-10-23

No results posted yet for this study

Summary

This is a prospective, randomized, controlled clinical trial in which participants with NYHA class II or III and symptomatic Heart Failure with reduced Ejection Fraction (HFrEF) (Ejection Fraction (EF) ≤ 45%) will be assigned to one of two treatment groups: standard of care or breathing therapy.

Conditions

  • Diastolic Heart Failure

Interventions

BEHAVIORAL

Meo Health Breathing and humming exercises

The Intervention Group will receive training on the Meo Health breathing therapy, which will include: * Being shown the Meo Health Breathing Therapy On-Boarding video * Orientation to breathing application: Participants will be assisted in downloading and customizing the Breathe application. * Zoom tutorial: Participants will be assisted in setting up and navigating Zoom application for use with the Meo Health breathing coach. Within one month of the baseline visit, participants in the intervention group will have a 20 minute one-on-one training session with the Meo Health breathing coach. This will mark the beginning of their respiratory training intervention. A 3 month visit will occur 3 months (± 14 days) from the one-on-one training session for participants in the intervention group. A 6 month visit will occur 6 months (± 14 days) from the one-on-one training session for participants in the intervention group.

Sponsors & Collaborators

  • Louise von Hess Medical Research Institute

    collaborator OTHER

  • Lancaster General Hospital

    lead OTHER

Principal Investigators

  • Roy Small, MD · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2025-06-20
Completion
2025-09-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223751 on ClinicalTrials.gov