Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure

NCT05223751 | Terminated DMC

• 1 other identifier: 2021-XXXX-LGHP
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

heart failure

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 6 months for the 6-minute walk test (6MWT)

  Distance (m) covered in six minutes from baseline to 6 months

  Baseline, 6 months

Secondary Outcomes (3)

• Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) quality of life score

  Baseline, 3 months, 6 months

• Pulmonary parameters: Peak expiratory flow

  Baseline, 3 months, 6 months

• New York Heart Association (NYHA) Class (graded I-IV) Proportion Improved 1 Class

  Baseline, 6 months

Study Arms (2)

HRV4 + Breathing and Humming Training

EXPERIMENTAL

On a biweekly basis, and with the other members of their subgroup within the cohort, participants will meet with the Meo Health breathing coach on Zoom for approximately 30 minutes. These sessions will encourage participants to complete their daily exercises and provide additional respiratory training.

Behavioral: Meo Health Breathing and humming exercises

HRV4 Only

NO INTERVENTION

Control participants will complete the daily heart rate variability (HRV) reading using the HRV4Training application.

Interventions

Meo Health Breathing and humming exercises BEHAVIORAL

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.

HRV4 + Breathing and Humming Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Signed informed consent
• NYHA class II-III heart failure
• EF ≤ 45% (echo within 1 year of enrollment)
• At least 30 days of stable medical regimen (no new neurohormonal blockade or Sodium-glucose co-transporter 2 inhibitors (SGLT2i). Dose adjustments allowed)
• Likely to be compliant with breath training as assessed by the provider
• Availability of a "smart" phone and internet access
• Established care at Lancaster General Health Penn Medicine

You may not qualify if:

• Cardiac resynchronization therapy (CRT) within 6 months
• Severe Chronic obstructive pulmonary disease (COPD)
• History of diaphragm paralysis
• Unable or unwilling to complete respiratory training protocol
• Decompensated or American College of Cardiology (ACC) Stage D Heart Failure (HF)
• Prior or planned chest/abdominal or nasal/facial surgery within 6 months
• Neuromuscular disease which impairs respiration
• Diagnosed cognitive impairment (unable to participate in training)
• Untreated obstructive severe sleep apnea (AHI \> 30)
• Severe valvular heart disease
• Uncontrolled atrial fibrillation (Ave Heart Rate (HR) \> 100 bpm)
• Orthopedic or other limitations which impair the 6-minute walk test

Sponsors & Collaborators

• Lancaster General Hospital: lead
• Louise von Hess Medical Research Institute: collaborator

Study Sites (1)

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Roy Small, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: February 7, 2022
• Primary Completion: June 20, 2025
• Study Completion: September 12, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)