Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether carvedilol treatment of patients with pulmonary arterial hypertension and associated right heart failure is safe and results in an improved function of the right heart.
Patients with pulmonary arterial hypertension (PAH) will be treated with carvedilol for 24 weeks. During this time, carvedilol will be titrated from an initial dose of 3.125mg BID to a maximal dose of 25mg BID. At the start and end of the study, we will obtain cardiac MRI, 6 minute walk distance, brain natriuretic peptide (serum), echocardiogram, and functional class assessment. Our primary outcome is a change in right ventricular ejection fraction with cardiac MRI.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carvedilol | Experimental | Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | twice daily oral treatment in escalating dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Right Ventricular Ejection Fraction | Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only | baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Right Ventricular End Systolic Volume | right ventricular end systolic volume determined by MRI | baseline and 6 months |
| Change in 6 Minute Walk Distance | baseline and 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel C Grinnan, M.D | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24930531 | Derived | Grinnan D, Bogaard HJ, Grizzard J, Van Tassell B, Abbate A, DeWilde C, Priday A, Voelkel NF. Treatment of group I pulmonary arterial hypertension with carvedilol is safe. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1562-4. doi: 10.1164/rccm.201311-2025LE. No abstract available. |
Not provided
Not provided
IPD will not be shared
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Carvedilol | Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients had pulmonary arterial hypertension, on pulmonary vasodilator therapy at baseline
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Carvedilol | Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI Carvedilol: twice daily oral treatment in escalating dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Change in Right Ventricular Ejection Fraction | Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only | Patients with right heart catheterization confirmed pulmonary arterial hypertension, already on pulmonary vasodilator therapy | Posted | Mean | 95% Confidence Interval | % RVEF | baseline, 6 months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carvedilol | Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI Carvedilol: twice daily oral treatment in escalating dose |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | Metabolism and nutrition disorders | Non-systematic Assessment | mild, resolved with dose reduction and slow rate of titration |
Small number of patients enrolled. This study is hypothesis generating and was meant to lead to larger studies of carvedilol in pulmonary hypertension
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dan Grinnan, MD | Virginia Commonwealth University Health System | 804-828-9000 | daniel.grinnan@vcuhealth.org |
Not provided
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in Tricuspid Annular Plane Systolic Excursion | Higher values indicate a better outcome. | baseline and 6 months |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Right ventricular ejection fraction of blood | Mean | Full Range | % of ejected ventricular vol of blood |
|
| Six minute walk distance | Mean | Full Range | meters |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in Right Ventricular End Systolic Volume | right ventricular end systolic volume determined by MRI | Posted | Number | mL | baseline and 6 months |
|
|
|
|
| Secondary | Change in 6 Minute Walk Distance | The patient who was excluded from analysis developed an orthopedic injury during the study and was unable to complete the walking test at conclusion of the study | Posted | Number | feet | baseline and 6 months |
|
|
|
|
| Secondary | Change in Tricuspid Annular Plane Systolic Excursion | Higher values indicate a better outcome. | The patient excluded from the analysis was unable to be present for the final echo-cardiogram due to lack of transportation and distance from the hospital. Multiple attempts to schedule the study test were made through phone and email. | Posted | Number | centimeters | baseline and 6 months |
|
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
|
| hypotension | Cardiac disorders | Non-systematic Assessment | asymptomatic. Mild, resolved with dose reduction |
|
Not provided
Not provided
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Participant 4 |
|
| Participant 5 |
|
| Participant 6 |
|
| Measurements |
|---|
|
| Participant 5 |
|
| Participant 6 |
|
| Title | Measurements |
|---|---|
|
| Participant 5 |
|
| Participant 6 |
|