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Pulmonary arterial hypertension (PAH) is a progressive disease that results in severe activity limitation and death. There are few treatments for PAH and the available medications are expensive, difficult to administer and have significant toxicities.
(-)-Epicatechin is a non-toxic compound that naturally occurs in foods such as tea, wine and chocolate. Clinical intervention studies using dark chocolate in normal volunteers and subjects at risk for or with established cardiovascular disease have demonstrated improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, glucose tolerance and inflammatory markers.
Our study intends to examine the hemodynamics effects of purified (-)-epicatechin in subjects with pulmonary arterial hypertension. We hypothesize purified (-)-epicatechin will reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (-)-Epicatechin | Experimental | A single dose of 100mg or 200mg (-)-Epicatechin to be administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (-)-Epicatechin | Drug | A single dose of purified (-)-epicatechin will be administered orally to subjects after a regularly scheduled right heart catheterization. The subjects will be monitored for 5 hours and released. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Vascular Resistance Index | This study will assess acute hemodynamic effects, specifically effects on pulmonary vascular resistance index (PVRI), of a single dose of purified (-)-epicatechin in patients with patients with PAH. | up to 5 hours after right heart catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function and hemodynamics | Secondary objectives are to determine if endothelial function, right heart function, nitric oxide and mitochondrial function improve following consumption of purified (-)-epicatechin. | up to 5 hours after right heart catheterization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Barnett, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94110 | United States |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002392 | Catechin |
| ID | Term |
|---|---|
| D002839 | Chromans |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| D006571 |
| Heterocyclic Compounds |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |