External Body Pressure in Heart Failure With Preserved Ejection Fraction
- Conditions
- Heart Failure, Diastolic
- Interventions
- Diagnostic Test: Positive or negative pressure
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Patients with heart failure (Aim 2) Positive or negative pressure - Control: Healthy Volunteers (Aim 1) Positive or negative pressure - Experimental: Patients with heart failure (Aim 1) Positive or negative pressure -
- 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