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Respiratory Training for Heart Failure (PART-HF Trial)
N/A
Waitlist Available
Led By Roy Small, MD
Research Sponsored by Lancaster General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
NYHA class II-III heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
PART-HF Trial Summary
This trial will compare two treatments for heart failure. One is the standard of care and the other is a breathing therapy.
Who is the study for?
This trial is for adults with NYHA class II or III heart failure and an Ejection Fraction (EF) of 45% or less. Participants must have been on a stable medical regimen for at least 30 days, be likely to follow the breathing training, have a smartphone with internet, and be under care at Lancaster General Health Penn Medicine.Check my eligibility
What is being tested?
The study compares standard heart failure care to an added breathing therapy involving Stasis Breathing and humming exercises. It's designed to see if these exercises can help improve symptoms in patients with reduced heart function.See study design
What are the potential side effects?
Since this trial involves non-invasive breathing exercises, side effects may include discomfort from the training protocol or possible fatigue due to exertion during respiratory training.
PART-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have moderate heart failure.
PART-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to 6 months for the 6-minute walk test (6MWT)
Secondary outcome measures
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) quality of life score
New York Heart Association (NYHA) Class (graded I-IV) Proportion Improved 1 Class
Pulmonary parameters: Peak expiratory flow
PART-HF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HRV4 + Breathing and Humming TrainingExperimental Treatment1 Intervention
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.
Group II: HRV4 OnlyActive Control1 Intervention
Control participants will complete the daily heart rate variability (HRV) reading using the HRV4Training application.
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Who is running the clinical trial?
Lancaster General HospitalLead Sponsor
22 Previous Clinical Trials
3,678 Total Patients Enrolled
4 Trials studying Heart Failure
1,032 Patients Enrolled for Heart Failure
Louise von Hess Medical Research InstituteOTHER
3 Previous Clinical Trials
263 Total Patients Enrolled
Roy Small, MDPrincipal InvestigatorMedical Director
1 Previous Clinical Trials
3 Total Patients Enrolled
1 Trials studying Heart Failure
3 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a muscle condition that affects my breathing.My medication has been stable for at least 30 days without starting new heart or diabetes drugs.I have had a heart device implanted within the last 6 months.I cannot or do not want to follow a breathing exercise program.I am 18 years old or older.I have severe heart failure that severely limits my daily activities.I have severe COPD.I have severe sleep apnea that hasn't been treated.My heart often beats faster than 100 beats per minute.I have physical limitations that prevent me from walking for 6 minutes.I have had a paralyzed diaphragm.I have had or will have surgery on my chest, abdomen, or face within 6 months.I have moderate heart failure.I have severe heart valve disease.I have been diagnosed with a cognitive impairment that prevents me from participating in training.Your heart's pumping function is less than 45%, as measured by an echocardiogram within the past year.
Research Study Groups:
This trial has the following groups:- Group 1: HRV4 + Breathing and Humming Training
- Group 2: HRV4 Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently enrolling participants in this experiment?
"Per the information on clinicaltrials.gov, this specific trial is no longer recruiting participants. The first post was made on February 7th 2022 and the latest update came October 25th 2022. While this particular study has closed its participant recruitment, there are still a total of 706 other studies currently seeking patients."
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