External Body Pressure in Heart Failure With Preserved Ejection Fraction

August 18, 2026 updated by: Duke University

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 Oxygen (O2) Consumption From Rest to 20 Watts Exercise
Time Frame: Day 1
A positive value indicates greater O2 consumption.
Day 1
Change in Cardiac Output From Rest to 0 Watts Exercise
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cardiac Output From Rest to 20 Watts Exercise
Time Frame: Day 1
Day 1
Change in Heart Rate From Rest to 0 Watts Exercise
Time Frame: Day 1
A positive value indicates and increase in heart rate.
Day 1
Change in Heart Rate From Rest to 20 Watts Exercise
Time Frame: Day 1
A positive value indicates an increase in heart rate.
Day 1
Change in Respiration From Rest to 20 Watts Exercise
Time Frame: Day 1
A positive value indicates an increase in respiration.
Day 1
Change in O2 Consumption From Rest to 0 Watts Exercise
Time Frame: Day 1
A positive value indicates an increase in oxygen consumption.
Day 1
Change in O2 Consumption From Rest to 20 Watts
Time Frame: Day 1
A positive value indicates an increase in oxygen consumption.
Day 1
Change in Wedge Pressure From Rest to 20 Watts
Time Frame: Day 1
Day 1
Change in Symptom Burden From Rest to 20 Watts
Time Frame: Day 1
Day 1

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Study Chair: Hemming, Duke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

September 11, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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