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Completed

NCT Number: NCT05764564

External Body Pressure in Heart Failure With Preserved Ejection Fraction

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).

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Key information

Conditions

Heart Failure, Diastolic Cardiovascular Diseases Heart Diseases Heart Failure

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Positive or negative pressure

Diagnostic Test

Positive or negative pressure is applied via a closed chamber.

Primary outcomes

  1. change in exercise cardiac output

    Time frame: Day 1

    Change in cardiac output from rest to 0 Watts exercise

Secondary outcomes

  1. change in exercise cardiac output

    Time frame: Day 1

    Change in cardiac output from rest to 20 Watts exercise

  2. change in heart rate

    Time frame: Day 1

    Change in heart rate from rest to 0 Watts exercise

  3. change in heart rate

    Time frame: Day 1

    Change in heart rate from rest to 20 Watts exercise

  4. change in respiratory rate

    Time frame: Day 1

    Change in heart rate from rest to 20 Watts exercise

  5. change in O2 consumption

    Time frame: Day 1

    Change in O2 consumption from rest to 0 Watts exercise

  6. change in O2 consumption

    Time frame: Day 1

    Change in O2 consumption from rest to 20 Watts exercise

  7. Change in wedge pressure

    Time frame: Day 1

    Change in wedge pressure from rest to 0 Watts exercise

  8. Change in wedge pressure

    Time frame: Day 1

    Change in wedge pressure from rest to 20 Watts exercise

Other outcomes

  1. Symptom burden

    Time frame: Day 1

    from rest to peak exertion we will assess symptom burden with dyspnea scales

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

External Body Pressure and the Impact on Exercise in Heart Failure With Preserved Ejection

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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