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External Body Pressure in Heart Failure With Preserved Ejection Fraction

StatusTerminated
PhaseNot applicable
Started2023-04-21
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
Study Status v12
Reclassified as terminated (was completed)
Trial terminated: Study was terminated at the completion of Aim 1 due to lack of time and funding to complete the more complex Aim 2.
Results posted: 2026-09-11
2026-06-29
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats v11
Secondary endpoints6 to 8 entries
Change in CardiacO2 OutputConsumption From Rest to 020 Watts Change Exercisein Wedge Pressure From Rest to 20 Watts Change in Symptom Burden From Rest to 20 Watts
Primary endpoints1 to 2 entries
Change in Cardiac Output From Rest to 0 Watts Exercise
2026-05-20
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v10
PhasePhase 1/2→Not applicable
Secondary endpoints8 to 6 entries
changeChange in exerciseCardiac cardiacOutput outputFrom Rest to 0 Watts Exercise changeChange in heartCardiac rateOutput From Rest to 20 Watts Exercise changeChange in heartHeart rateRate From Rest to 0 Watts Exercise changeChange in respiratoryHeart rateRate From Rest to 20 Watts Exercise changeChange in Respiration From Rest to 20 Watts Exercise Change in O2 consumption changeConsumption inFrom O2Rest consumption Changeto in0 wedgeWatts pressure Change in wedge pressureExercise
Primary endpoints1 entry, revised
changeChange in exerciseOxygen cardiac(O2) outputConsumption From Rest to 20 Watts Exercise
2026-01-28
Suspended→Completed Study Status, Study Design v9
Trial statusSuspended→Completed
Reason stoppedCompleted Aim 1. Preparations to begin Aim 2.→not stated
Primary completion dateestimated 2026-01-01→confirmed 2025-05-31
Completion dateestimated 2026-01-01→confirmed 2025-05-31
Enrollment targetestimated 60→confirmed 27
2025-07-22
Recruiting→Suspended Study Status, Contacts/Locations v8
Trial statusRecruiting→Suspended
Reason stoppednot stated→Completed Aim 1. Preparations to begin Aim 2.
Study sitesdetails revised at 1 of 1 site
Show 7 earlier versions
2025-02-03
Study Status v7
Primary completion date2025-01-01→2026-01-01
Completion date2025-01-01→2026-01-01
2024-09-10
Suspended→Recruiting Study Status, Contacts/Locations v6
Trial statusSuspended→Recruiting
Reason stoppedInterim Data Analysis→not stated
Study sitesdetails revised at 1 of 1 site
2024-07-16
Recruiting→Suspended Study Status, Contacts/Locations v5
Trial statusRecruiting→Suspended
Reason stoppednot stated→Interim Data Analysis
Study sitesdetails revised at 1 of 1 site
2024-04-29
Study Status v4
Re-verified, no change to tracked fields
2023-05-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-05-30→confirmed 2023-04-21
Study sitesdetails revised at 1 of 1 site
2023-04-10
Study Status, Contacts/Locations v2
Start date2023-03-30→2023-05-30
Study sitescontacts updated at 1 of 1 site
2023-03-10
Study Status, Oversight v1
Re-verified, no change to tracked fields
2023-02-28
Original filing
Duke University
455 trials monitored
See 53 trials at risk
Heart Failure
1,854 trials monitored
See 95 trials at risk
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).
Trial Details
NCT Number NCT05764564
Lead Sponsor Duke University
Conditions Heart Failure, Diastolic
Enrollment 27 participants
Start Date 2023-04-21
Primary Completion 2025-05-31 (estimated)
Study Completion 2025-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-11