Ignite Creation Date:
2024-05-06 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05223751
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-28
First Post:
2022-01-25
Brief Title:
Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure
Sponsor:
Lancaster General Hospital
Organization:
Lancaster General Hospital
Study Overview
Official Title:
Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PART-HF
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
EnrollmentBaseline 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 21 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 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 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 Meo Health 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 MonthFinal 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 Meo Health 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 154 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 wont be interviewed
EnrollmentBaseline 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 21 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 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 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 Meo Health 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 MonthFinal 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 Meo Health 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 154 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 wont be interviewed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None