Heart Failure Clinical Trial

External Body Pressure in Heart Failure With Preserved Ejection Fraction

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).

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05764564

Recruitment Status:

Recruiting

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Ashley Burke
Contact
Marat Fudim, MD
Principal Investigator
David MacLeod, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05764564

Recruitment Status:

Recruiting

Sponsor:


Duke University

How clear is this clinincal trial information?

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