External Body Pressure in Heart Failure With Preserved Ejection Fraction
Heart Failure, Diastolic
About this trial
This is an interventional diagnostic trial for Heart Failure, Diastolic
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
Sites / Locations
- Duke University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Experimental: Patients with heart failure (Aim 1)
Control: Healthy Volunteers (Aim 1)
Experimental: Patients with heart failure (Aim 2)