Heart Failure, Diastolic
Conditions
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).
Interventions
DIAGNOSTIC_TESTPositive or negative pressure
Positive or negative pressure is applied via a closed chamber.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion 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 *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oxygen (O2) Consumption From Rest to 20 Watts Exercise | Day 1 | A positive value indicates greater O2 consumption. |
| Change in Cardiac Output From Rest to 0 Watts Exercise | Day 1 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiac Output From Rest to 20 Watts Exercise | Day 1 | — |
| Change in Heart Rate From Rest to 0 Watts Exercise | Day 1 | A positive value indicates and increase in heart rate. |
| Change in Heart Rate From Rest to 20 Watts Exercise | Day 1 | A positive value indicates an increase in heart rate. |
| Change in Respiration From Rest to 20 Watts Exercise | Day 1 | A positive value indicates an increase in respiration. |
| Change in O2 Consumption From Rest to 0 Watts Exercise | Day 1 | A positive value indicates an increase in oxygen consumption. |
| Change in O2 Consumption From Rest to 20 Watts | Day 1 | A positive value indicates an increase in oxygen consumption. |
| Change in Wedge Pressure From Rest to 20 Watts | Day 1 | — |
| Change in Symptom Burden From Rest to 20 Watts | Day 1 | — |
Countries
United States
Contacts
STUDY_CHAIRHemming
Duke
Participant flow
Pre-assignment details
Study was terminated after completion of Aim 1 enrollment. No Aim 2 participants were enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 10.1 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 8 |
| other Total, other adverse events | 0 / 13 | 0 / 8 |
| serious Total, serious adverse events | 0 / 13 | 0 / 8 |
Outcome results
None listed