External Body Pressure in Heart Failure With Preserved Ejection Fraction

Phase 1

Suspended

• Conditions: Heart Failure, Diastolic

• Registration Number: NCT05764564
• Lead Sponsor: Duke University

Brief 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. Aim 1 will study healthy volunteers and heart failure patients non invasively while Aim 2 will study heart failure patients invasively (intracardiac pressures).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-25
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Study Start: 2023-04-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in exercise cardiac output	Day 1	Change in cardiac output from rest to 0 Watts exercise

Secondary Outcome Measures

Name	Time	Method
change in heart rate	Day 1	Change in heart rate from rest to 20 Watts exercise
change in O2 consumption	Day 1	Change in O2 consumption from rest to 20 Watts exercise
change in respiratory rate	Day 1	Change in heart rate from rest to 20 Watts exercise
Change in wedge pressure	Day 1	Change in wedge pressure from rest to 20 Watts exercise
change in exercise cardiac output	Day 1	Change in cardiac output from rest to 20 Watts exercise

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States