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External Body Pressure for Heart Failure
Phase 1 & 2
Recruiting
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable HF drug regimen for the preceding 1 month
Ambulatory [assistive devices ok]
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
Study Summary
This trial will test if positive and negative body pressure can improve exercise capacity, symptoms, blood volume and heart health in those with heart failure.
Who is the study for?
Adults over 30 with heart failure and preserved ejection fraction (HFpEF), able to speak English, on a stable heart medication for at least a month. They must have certain levels of wedge pressure indicating HF severity. Some will need an elective right heart catheterization. Excludes those with recent severe cardiac events, uncontrolled arrhythmias or blood pressure, significant lung disease, large aneurysms, electrolyte issues, pregnancy or inability to walk.Check my eligibility
What is being tested?
The trial is examining how applying positive or negative body pressure affects exercise capacity and heart function in people with HFpEF. It includes two aims: non-invasive testing on healthy volunteers and patients; invasive testing measuring direct intracardiac pressures during scheduled catheterizations.See study design
What are the potential side effects?
While the study does not list specific side effects from the interventions (positive/negative body pressure), potential risks may include discomfort due to changes in body pressure and complications related to invasive procedures like catheterization.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart failure medication has not changed in the last month.
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I can walk with or without help from devices.
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I have moderate heart condition symptoms.
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I am 30 years old or older.
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I am scheduled for a right heart catheterization at Duke University Hospital.
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My heart pumps well, with an ejection fraction of 50% or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in wedge pressure
change in O2 consumption
change in exercise cardiac output
+2 moreOther outcome measures
Symptom burden
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: Patients with heart failure (Aim 2)Experimental Treatment1 Intervention
Group II: Experimental: Patients with heart failure (Aim 1)Experimental Treatment1 Intervention
Group III: Control: Healthy Volunteers (Aim 1)Active Control1 Intervention
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,409,041 Total Patients Enrolled
63 Trials studying Heart Failure
46,457 Patients Enrolled for Heart Failure
HemmingStudy ChairDuke
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Patients with heart failure (Aim 1)
- Group 2: Control: Healthy Volunteers (Aim 1)
- Group 3: Experimental: Patients with heart failure (Aim 2)
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.
Is this research project currently enrolling participants?
"The listed clinical trial on clinicaltrials.gov is not presently recruiting participants, even though it was initially posted in March 30th 2023 and updated lastly at February 28th 2023. However, 709 other studies are right now looking for patients to enrol."
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