External Body Pressure in Heart Failure With Preserved Ejection Fraction

Duke University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Heart Failure, Diastolic

Treatments: Diagnostic Test: Positive or negative pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT05764564

Pro00112081

Details and patient eligibility

About

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).

Enrollment: 27 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Experimental: Patients with heart failure (Aim 1)

Experimental group

Treatment:

Diagnostic Test: Positive or negative pressure

Control: Healthy Volunteers (Aim 1)

Active Comparator group

Treatment:

Diagnostic Test: Positive or negative pressure

Experimental: Patients with heart failure (Aim 2)

Experimental group

Treatment:

Diagnostic Test: Positive or negative pressure