Impact of Body Pressure on Heart Failure with Preserved Ejection Fraction
External Body Pressure and the Impact on Exercise in Heart Failure With Preserved Ejection
This study is testing how changes in body pressure affect exercise ability and heart function in people with heart failure and preserved ejection fraction.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05764564 on ClinicalTrials.gov |
What this trial studies
This study investigates how positive and negative body pressure affects exercise capacity, symptoms, blood volume distribution, and central cardiac hemodynamics in patients with heart failure and preserved ejection fraction (HFpEF). It consists of two aims: the first involves non-invasive assessments in both healthy volunteers and HFpEF patients, while the second focuses on invasive measurements in HFpEF patients undergoing right heart catheterization. The study aims to provide insights into the physiological responses to body pressure changes in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 30 and older with a diagnosis of HFpEF and stable symptoms.
Not a fit: Patients with recent heart failure hospitalizations, specific cardiomyopathies, or uncontrolled arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with heart failure and preserved ejection fraction.
How similar studies have performed: While the specific approach of using body pressure in HFpEF is novel, similar studies have explored hemodynamic responses in heart failure, indicating potential for success.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Marat Fudim
- Email: marat.fudim@duke.edu
- Phone: 9196815816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.