Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Patients with heart failure (Aim 1) | Experimental |
| |
| Control: Healthy Volunteers (Aim 1) | Active Comparator |
| |
| Experimental: Patients with heart failure (Aim 2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive or negative pressure | Diagnostic Test | Positive or negative pressure is applied via a closed chamber. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in exercise cardiac output | Change in cardiac output from rest to 0 Watts exercise | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| change in exercise cardiac output | Change in cardiac output from rest to 20 Watts exercise | Day 1 |
| change in heart rate | Change in heart rate from rest to 0 Watts exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom burden | from rest to peak exertion we will assess symptom burden with dyspnea scales | Day 1 |
Heart Failure Study Population
Inclusion Criteria (Aim 1 and 2):
Exclusion Criteria (Aim 1 and 2):
Inclusion Criteria (Aim 1):
Exclusion Criteria (Aim 1):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hemming | Duke | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2026 | Jun 16, 2026 | 10 | ||
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015870 | Gene Expression |
| ID | Term |
|---|---|
| D055614 | Genetic Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 1 |
| change in heart rate | Change in heart rate from rest to 20 Watts exercise | Day 1 |
| change in respiratory rate | Change in heart rate from rest to 20 Watts exercise | Day 1 |
| change in O2 consumption | Change in O2 consumption from rest to 0 Watts exercise | Day 1 |
| change in O2 consumption | Change in O2 consumption from rest to 20 Watts exercise | Day 1 |
| Change in wedge pressure | Change in wedge pressure from rest to 0 Watts exercise | Day 1 |
| Change in wedge pressure | Change in wedge pressure from rest to 20 Watts exercise | Day 1 |