Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure (PART-HF)
Primary Purpose
Diastolic Heart Failure
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stasis Breathing and humming exercises
Sponsored by
About this trial
This is an interventional treatment trial for Diastolic Heart Failure focused on measuring heart failure
Eligibility Criteria
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Sites / Locations
- Lancaster General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HRV4 + Breathing and Humming Training
HRV4 Only
Arm Description
On a biweekly basis, and with the other members of their subgroup within the cohort, participants will meet with the Stasis breathing coach on Zoom for approximately 30 minutes. These sessions will encourage participants to complete their daily exercises and provide additional respiratory training.
Control participants will complete the daily heart rate variability (HRV) reading using the HRV4Training application.
Outcomes
Primary Outcome Measures
Change from baseline to 6 months for the 6-minute walk test (6MWT)
Distance (m) covered in six minutes from baseline to 6 months
Secondary Outcome Measures
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) quality of life score
Change in Kansas City Cardiomyopathy Questionnaire 12 - Quality of Life (KCCQ12-QL) score
KCCQ12-QL score corresponds to Questions 6 and 7. Responses are coded as follows:
Question 6 Response It has extremely limited my enjoyment of life = 1 It has limited my enjoyment of life quite a bit = 2 It has moderately limited my enjoyment of life = 3 It has slightly limited my enjoyment of life = 4 It has not limited my enjoyment of life at all = 5
Question 7 Response Not at all satisfied = 1 Mostly dissatisfied = 2 Somewhat satisfied = 3 Mostly satisfied = 4 Completely satisfied = 5
If responses to both questions are missing, no score is computed. Otherwise, the score is calculated by taking the average of the non-missing responses and rescaling to 0-100, as follows:
KCCQ12-QL = 100*[(average of Questions 6 and 7) - 1]/4
Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest.
Pulmonary parameters: Peak expiratory flow
Change in peak expiratory flow spirometry
New York Heart Association (NYHA) Class (graded I-IV) Proportion Improved 1 Class
Proportion of subjects that decreased 1 NYHA class.
NYHA Classification - The Stages of Heart Failure:
Class I - Cardiac disease, but no symptoms and no limitation in ordinary physical activity.
Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Significant limitation in activity due to symptoms. Comfortable only at rest.
Class IV - Severe limitations. Symptoms even while at rest. No NYHA class listed or unable to determine.
Full Information
NCT ID
NCT05223751
First Posted
January 25, 2022
Last Updated
January 30, 2023
Sponsor
Lancaster General Hospital
Collaborators
Louise von Hess Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05223751
Brief Title
Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure
Acronym
PART-HF
Official Title
Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lancaster General Hospital
Collaborators
Louise von Hess Medical Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
To evaluate the effect of breathing training on the 6-minute walk test in a population of heart failure patients.
Enrollment/Baseline Visit During the enrollment visit, the participant will meet with the clinical research coordinator (CRC) to review any final questions regarding the study and the informed consent form will be signed. The enrollment visit must occur within one month of screening. Once the informed consent is signed, the following procedures will occur.
Randomization: Participants will be randomized using REDCap in a 2:1 blocking method into the intervention group (breathing therapy) or the control (standard of care).
N-terminal (NT)-pro hormone BNP (NT-proBNP): If an NT-proBNP was collected as standard of care within 3 months of enrollment, this can be used for study purposes and compared to the 6 month NT-proBNP.
New York Heart Association Class: If the NYHA class is completed as standard of care within 3 months of enrollment, this can be used for study proposes.
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Respiratory Rate
Peak Expiratory Flow
6-minute walk test
Orientation to the Heart Rate Variability 4 (HRV4) Training application: This will include downloading, creating an account for, and training the participant on the application.
The Intervention Group will also receiving training on the Stasis breathing therapy, which will include:
Being shown the Stasis Breathing Therapy On-Boarding video
Orientation to breathing application: Participants will be assisted in downloading and custom setting the Breathe application.
Zoom Within one month of the baseline visit, participants in the intervention group will have a one-on-one training session with the Stasis breathing coach. This will mark the beginning of their breathing therapy intervention.
3 Month Visit The 3 month visit will occur 3 months (± 14 days) from the one-on-one training session for participants in the intervention group . The participant will only meet with the CRC at the 3 month visit and all assessments will be completed by the CRC.
NYHA class
KCCQ
Respiratory Rate
Peak Expiratory Flow
6-minute walk test
Assess compliance from HRV4 Training application questions
Assess any possible adverse events
6 Month/Final Visit The 6 month visit will occur 6 months (± 14 days) from the one-on-one training session for participants in the intervention group. The participant will meet with the CRC at the 6 month visit, any assessments not completed as Standard of Care (SOC), will be completed by the CRC.
NT-proBNP: If an NT-proBNP is ordered as standard of care for the participant, this can be used for study purposes and compared to the baseline NT-proBNP.
NYHA class: If the NYHA class is completed as standard of care, this can be used for study purposes and compared to the baseline and 3 month values.
KCCQ
Respiratory Rate
Peak Expiratory Flow
6-minute walk test
Assess any possible adverse events
9 Month Structured Telephone Survey The 9 month structured telephone interview will take place for all participants who receive breathing training from Stasis. Participants will be called by a study team member who will facilitate a short (3-5 minute) telephone survey about adherence and changes in health outcomes as a result of participation in the trial. (See appendix 15.4). The study team member will record all answers into REDCap. Upon completion of the survey, participants will be closed out of the study. If a study team member is unable to get in contact with a participant after two attempts, their status will be marked as "closed to follow-up" and they won't be interviewed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure
Keywords
heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HRV4 + Breathing and Humming Training
Arm Type
Experimental
Arm Description
On a biweekly basis, and with the other members of their subgroup within the cohort, participants will meet with the Stasis breathing coach on Zoom for approximately 30 minutes. These sessions will encourage participants to complete their daily exercises and provide additional respiratory training.
Arm Title
HRV4 Only
Arm Type
No Intervention
Arm Description
Control participants will complete the daily heart rate variability (HRV) reading using the HRV4Training application.
Intervention Type
Behavioral
Intervention Name(s)
Stasis Breathing and humming exercises
Intervention Description
The Intervention Group will receive training on the Stasis breathing therapy, which will include:
Being shown the Stasis 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 Stasis 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 Stasis 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.
Primary Outcome Measure Information:
Title
Change from baseline to 6 months for the 6-minute walk test (6MWT)
Description
Distance (m) covered in six minutes from baseline to 6 months
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) quality of life score
Description
Change in Kansas City Cardiomyopathy Questionnaire 12 - Quality of Life (KCCQ12-QL) score
KCCQ12-QL score corresponds to Questions 6 and 7. Responses are coded as follows:
Question 6 Response It has extremely limited my enjoyment of life = 1 It has limited my enjoyment of life quite a bit = 2 It has moderately limited my enjoyment of life = 3 It has slightly limited my enjoyment of life = 4 It has not limited my enjoyment of life at all = 5
Question 7 Response Not at all satisfied = 1 Mostly dissatisfied = 2 Somewhat satisfied = 3 Mostly satisfied = 4 Completely satisfied = 5
If responses to both questions are missing, no score is computed. Otherwise, the score is calculated by taking the average of the non-missing responses and rescaling to 0-100, as follows:
KCCQ12-QL = 100*[(average of Questions 6 and 7) - 1]/4
Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest.
Time Frame
Baseline, 3 months, 6 months
Title
Pulmonary parameters: Peak expiratory flow
Description
Change in peak expiratory flow spirometry
Time Frame
Baseline, 3 months, 6 months
Title
New York Heart Association (NYHA) Class (graded I-IV) Proportion Improved 1 Class
Description
Proportion of subjects that decreased 1 NYHA class.
NYHA Classification - The Stages of Heart Failure:
Class I - Cardiac disease, but no symptoms and no limitation in ordinary physical activity.
Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Significant limitation in activity due to symptoms. Comfortable only at rest.
Class IV - Severe limitations. Symptoms even while at rest. No NYHA class listed or unable to determine.
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Small, MD
Organizational Affiliation
Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure
We'll reach out to this number within 24 hrs