External Body Pressure in Heart Failure With Preserved Ejection Fraction
NCT ID: NCT05764564
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2023-04-21
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Experimental: Patients with heart failure (Aim 1)
Positive or negative pressure
Positive or negative pressure is applied via a closed chamber.
Control: Healthy Volunteers (Aim 1)
Positive or negative pressure
Positive or negative pressure is applied via a closed chamber.
Experimental: Patients with heart failure (Aim 2)
Positive or negative pressure
Positive or negative pressure is applied via a closed chamber.
Interventions
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Positive or negative pressure
Positive or negative pressure is applied via a closed chamber.
Eligibility Criteria
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Inclusion Criteria
* Established diagnosis of HFpEF with left ventricular ejection fraction greater than or equal to 50%
* NYHA II-III symptoms
* Stable HF drug regimen for the preceding 1 month
* Wedge pressure greater than or equal to 15 mmHg at rest or greater than or equal to 25 mmHg with peak exercise
* (For Aim 2 only) Scheduled for an elective right heart catheterization at Duke University Hospital.
* Age greater than or equal to 30 yrs
* Able to speak English
* Ambulatory \[assistive devices ok\]
* Able to provide informed consent
Exclusion Criteria
* Infiltrative (ie amyloid) or hypertrophic cardiomyopathy
* Uncontrolled atrial or ventricular arrhythmia
* Chronic oxygen use
* History of vasovagal syncope
* Considered inappropriate to participate by PI or Sub-I
* Healthy Volunteers (Controls)
* Acute myocardial infarction (3-5 days)
* Unstable angina
* Uncontrolled arrhythmia causing symptoms or haemodynamic compromise
* Syncope
* Active endocarditis
* Acute myocarditis or pericarditis
* Symptomatic severe aortic aneurysm
* Uncontrolled asthma
* Arterial desaturation at rest on room air \<85%
* Untreated left main stem coronary stenosis
* Asymptomatic severe aortic stenosis
* Severe untreated arterial hypertension at rest (\>200 mm Hg systolic, \>120 mm Hg diastolic)
* Tachyarrhythmias or bradyarrhythmias
* Hypertrophic cardiomyopathy
* Significant pulmonary hypertension
* Thrombosis of the lower extremity until treated for a minimum of 2 weeks
* Within 2 weeks of acute symptomatic pulmonary embolus
* Abdominal aortic aneurysm \>8.0 cm
* Electrolyte abnormalities
* Pregnancy
* Inmate of correctional facility (i.e. prisoner)
* Diagnosed history of dementia
* Inability to ambulate independently
* Considered inappropriate to participate by Principal Investigator
30 Years
ALL
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Hemming
Role: STUDY_CHAIR
Duke
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00112081
Identifier Type: -
Identifier Source: org_study_id
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