Clinical trial NCT05764564: External Body Pressure in Heart Failure With Preserved Ejection Fraction
Official title: External Body Pressure and the Impact on Exercise in Heart Failure With Preserved Ejection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Heart Failure, Diastolic
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


Eligibility 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

Primary outcomes:
measure: change in exercise cardiac output
timeFrame: Day 1
Secondary outcomes:
measure: change in exercise cardiac output
timeFrame: Day 1
measure: change in heart rate
timeFrame: Day 1
measure: change in heart rate
timeFrame: Day 1
measure: change in respiratory rate
timeFrame: Day 1
measure: change in O2 consumption
timeFrame: Day 1
measure: change in O2 consumption
timeFrame: Day 1
measure: Change in wedge pressure
timeFrame: Day 1
measure: Change in wedge pressure
timeFrame: Day 1
Other outcomes:
measure: Symptom burden
timeFrame: Day 1
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke
name: Hemming
role: STUDY_CHAIR
References: