External Body Pressure in Heart Failure With Preserved Ejection Fraction

Launched by DUKE UNIVERSITY · Feb 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different types of body pressure can affect people with heart failure who have a preserved ability to pump blood (known as HFpEF). The goal is to see if applying positive or negative pressure can improve exercise capacity, symptoms, and blood flow in these patients. The study will involve two groups: one with healthy volunteers and another with patients who already have heart failure. Researchers will collect information non-invasively from both groups and then perform more detailed measurements in heart failure patients.

To participate in this trial, individuals must be at least 30 years old and have a confirmed diagnosis of heart failure with specific symptoms. They should also be on a stable medication regimen for heart failure for the past month. Those with recent heart-related hospitalizations or certain heart conditions will not be eligible. Participants can expect to undergo various tests to measure how their heart responds to changes in body pressure, helping researchers learn more about potential treatments for heart failure.

Gender

ALL

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