Heart Failure, DiastolicNCT05764564
External Body Pressure in Heart Failure With Preserved Ejection Fraction
A study testing Positive or negative pressure in people with Heart Failure, Diastolic, run by Duke University at 1 site in United States.
Trial summary
The primary objective of the study is to test the impact of positive and negative body pressure on exercise capacity, symptoms, blood volume distribution and central cardiac hemodynamics in patients with heart failure and preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- Positive or negative pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 30 yrs
- 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.
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- Age greater than or equal to 30 yrs
- Able to speak English
- Ambulatory [assistive devices ok]
- Able to provide informed consent
Who cannot join
- HF hospitalization for type I myocardial infarction within 3 months
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: External Body Pressure and the Impact on Exercise in Heart Failure With Preserved Ejection
The primary objective of the study is to test the impact of positive and negative body pressure on exercise capacity, symptoms, blood volume distribution and central cardiac hemodynamics in patients with heart failure and preserved ejection fraction. Aim 1 will study healthy volunteers and heart failure patients non invasively while Aim 2 will study heart failure patients invasively (intracardiac pressures).
- Conditions
- Heart Failure, Diastolic
- Being tested
- Positive or negative pressure
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive or negative pressureDiagnostic test
Positive or negative pressure is applied via a closed chamber.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Patients with heart failure (Aim 1) | Experimental | Not described Receives: Diagnostic Test: Positive or negative pressure |
| Control: Healthy Volunteers (Aim 1) | Active comparator | Not described Receives: Diagnostic Test: Positive or negative pressure |
| Experimental: Patients with heart failure (Aim 2) | Experimental | Not described Receives: Diagnostic Test: Positive or negative pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen (O2) Consumption From Rest to 20 Watts Exercise
A positive value indicates greater O2 consumption.
Measured: Day 1
Change in Cardiac Output From Rest to 0 Watts Exercise
Measured: Day 1
Secondary outcomes (8)
Change in Cardiac Output From Rest to 20 Watts Exercise
Measured: Day 1
Change in Heart Rate From Rest to 0 Watts Exercise
A positive value indicates and increase in heart rate.
Measured: Day 1
Change in Heart Rate From Rest to 20 Watts Exercise
A positive value indicates an increase in heart rate.
Measured: Day 1
Change in Respiration From Rest to 20 Watts Exercise
A positive value indicates an increase in respiration.
Measured: Day 1
Change in O2 Consumption From Rest to 0 Watts Exercise
A positive value indicates an increase in oxygen consumption.
Measured: Day 1
Change in O2 Consumption From Rest to 20 Watts
A positive value indicates an increase in oxygen consumption.
Measured: Day 1
Change in Wedge Pressure From Rest to 20 Watts
Measured: Day 1
Change in Symptom Burden From Rest to 20 Watts
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start21 Apr 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: Study was terminated at the completion of Aim 1 due to lack of time and funding to complete the more complex Aim 2.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hemming, Study chair, Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764564
- Sponsor's protocol ID
- Pro00112081
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2023
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Body Pressure and the Impact on Exercise in Heart Failure With Preserved Ejection
- ClinicalTrials.gov ID
- NCT05764564
- Acronym / sponsor ID
- Pro00112081
- Conditions
- Heart Failure, Diastolic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated at the completion of Aim 1 due to lack of time and funding to complete the more complex Aim 2.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 11 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to test the impact of positive and negative body pressure on exercise capacity, symptoms, blood volume distribution and central cardiac hemodynamics in patients with heart failure and preserved ejection fraction. Aim 1 will study healthy volunteers and heart failure patients non invasively while Aim 2 will study heart failure patients invasively (intracardiac pressures).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Patients with heart failure (Aim 1) | Experimental | Diagnostic Test: Positive or negative pressure |
| Control: Healthy Volunteers (Aim 1) | Active comparator | Diagnostic Test: Positive or negative pressure |
| Experimental: Patients with heart failure (Aim 2) | Experimental | Diagnostic Test: Positive or negative pressure |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
Key exclusion criteria (31 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive or negative pressurePositive or negative pressure is applied via a closed chamber. | Diagnostic test | Control: Healthy Volunteers (Aim 1), Experimental: Patients with heart failure (Aim 1), Experimental: Patients with heart failure (Aim 2) |
Primary outcome
Change in Oxygen (O2) Consumption From Rest to 20 Watts Exercise
Time frame: Day 1
A positive value indicates greater O2 consumption.
Change in Cardiac Output From Rest to 0 Watts Exercise
Time frame: Day 1
8 secondary outcomes
Change in Cardiac Output From Rest to 20 Watts Exercise
Time frame: Day 1
Change in Heart Rate From Rest to 0 Watts Exercise
Time frame: Day 1
Change in Heart Rate From Rest to 20 Watts Exercise
Time frame: Day 1
Change in Respiration From Rest to 20 Watts Exercise
Time frame: Day 1
Change in O2 Consumption From Rest to 0 Watts Exercise
Time frame: Day 1
Change in O2 Consumption From Rest to 20 Watts
Time frame: Day 1
Change in Wedge Pressure From Rest to 20 Watts
Time frame: Day 1
Change in Symptom Burden From Rest to 20 Watts
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hemming study chair
Duke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive or negative pressure in people with Heart Failure, Diastolic, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygen (O2) Consumption From Rest to 20 Watts Exercise (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.