External Body Pressure in Heart Failure With Preserved Ejection Fraction

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure, Diastolic
• Intervention / Treatment: Diagnostic test: Positive or negative pressure

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

• Heart Failure Study Population

• Inclusion Criteria (Aim 1 and 2):

  • 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.

• Exclusion Criteria (Aim 1 and 2):

  • 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
  • Healthy Volunteers (Controls)

• Inclusion Criteria (Aim 1):

  • Age greater than or equal to 30 yrs
  • Able to speak English
  • Ambulatory [assistive devices ok]
  • Able to provide informed consent

• Exclusion Criteria (Aim 1):

  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Patients with heart failure (Aim 1)	Diagnostic test: Positive or negative pressure; Positive or negative pressure is applied via a closed chamber.
Active Comparator: Control: Healthy Volunteers (Aim 1)	Diagnostic test: Positive or negative pressure; Positive or negative pressure is applied via a closed chamber.
Experimental: Experimental: Patients with heart failure (Aim 2)	Diagnostic test: Positive or negative pressure; Positive or negative pressure is applied via a closed chamber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in exercise cardiac output	Change in cardiac output from rest to 0 Watts exercise	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in exercise cardiac output	Change in cardiac output from rest to 20 Watts exercise	Day 1
change in heart rate	Change in heart rate from rest to 0 Watts exercise	Day 1
change in heart rate	Change in heart rate from rest to 20 Watts exercise	Day 1
change in respiratory rate	Change in heart rate from rest to 20 Watts exercise	Day 1
change in O2 consumption	Change in O2 consumption from rest to 0 Watts exercise	Day 1
change in O2 consumption	Change in O2 consumption from rest to 20 Watts exercise	Day 1
Change in wedge pressure	Change in wedge pressure from rest to 0 Watts exercise	Day 1
Change in wedge pressure	Change in wedge pressure from rest to 20 Watts exercise	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom burden	from rest to peak exertion we will assess symptom burden with dyspnea scales	Day 1

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Study Chair: Hemming, Duke

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: February 25, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Heart Failure, Diastolic; Genetic Phenomena; Gene Expression
• Other Study ID Numbers: Pro00112081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes