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Difficulty meeting enrollment goal
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The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a double-blind, placebo controlled trial.
Patients will be screened at the time of a diagnositic Right Heart Catheterization. Patients will be selected based on pressures measured during this procedure, current medications, and current symptoms. At baseline a 6 minute walk test and quality of life questionnaire will be administered. Medical records will be reviewed and results of recent testing will be recorded. Qualifying participants will be randomized to receive 90 days of either placebo or sildenafil 20 mg three times a day. Randomized patients will be followed for safety and efficacy by phone and as otherwise clinically indicated.
At the end of the 90 day treatment period, patients will be evaluated via 6 minute walk, quality of life questionnaire, and other diagnostic tests as clinically indicated. Primary outcome will be change in the 6 minute walk distance. Secondary outcomes will be based on clinically available results such as change in heart pressures measured by right heart catheterization and echocardiogram.
At the end of the treatment period, providers and patients will be unblinded in order to optimize further treatment.
To achieve statistical significance, 64 patients will be enrolled and randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo three times per day, orally |
|
| Sildenafil | Active Comparator | Sildenafil 20 mg three times per day, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | 20 mg three times daily by mouth for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise Tolerance | In a controlled laboratory environment, participants will be asked to walk on a treadmill as fast as they can for 6 minutes. The test will be conducted at baseline and after 90 days of treatment. Data will be presented as the change in distance (in feet) walked in 6 minutes between baseline and treatment. | Baseline and 90 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Right Ventricular Function | Right ventricular function will be measured using tricuspid annular plane systolic excursion via two dimensional apical four-chamber echocardiography. Data will be collected at baseline and after 90 days of treatment | Baseline and 90 day |
| Change in Cardiac Output Relative to Body Surface Area (Cardiac Index) |
Inclusion Criteria:
Exclusion Criteria:
hypersensitivity, allergy, or intolerable side effect to sildenafil
history of primary pulmonary hypertension, connective tissue disorder, severe chronic obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt
co-morbidities, limited exercise intolerance:
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| Name | Affiliation | Role |
|---|---|---|
| Maya E Guglin, MD, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27252841 | Derived | Guglin M, Rajagopalan N, Anaya P, Charnigo R. Sildenafil in heart failure with reactive pulmonary hypertension (Sildenafil HF) clinical trial (rationale and design). Pulm Circ. 2016 Jun;6(2):161-7. doi: 10.1086/685548. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo three times per day, orally Placebo: One capsule three times daily by mouth for 90 days |
| FG001 | Sildenafil | Sildenafil 20 mg three times per day, orally for 90 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants had baseline data collected. Only 10 Sildenafil and 12 Placebo had outcome data collects. Several were lost to follow up failures or withdrew either on their own or through PI recommendation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo three times per day, orally Placebo: One capsule TID PO for 90 days |
| BG001 | Sildenafil | Sildenafil 20 mg three times per day, orally Sildenafil: 20 mg TID PO for 90 days |
| 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 | Change in Exercise Tolerance | In a controlled laboratory environment, participants will be asked to walk on a treadmill as fast as they can for 6 minutes. The test will be conducted at baseline and after 90 days of treatment. Data will be presented as the change in distance (in feet) walked in 6 minutes between baseline and treatment. | Several participants were not analyzed for several reasons including death, failure to follow-up, PI withdrawal or subject withdrawal. In the Sildenafil group, 17 participants were consented while 10 were analyzed. In the Placebo group, 16 subjects were consented and 12 were analyzed. | Posted | Mean | Standard Error | feet | Baseline and 90 days |
|
Adverse events were collected for 90 days from the date of consent until the drug protocol was complete.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo three times per day, orally Placebo: One capsule TID PO for 90 days |
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There is a real risk that individuals presenting to the cardiology clinics will choose not to participate based on the physical exertion requirement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maya Guglin | University of Kentucky | 859-323-4738 | maya.guglin@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2016 | Jun 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug | One capsule three times daily by mouth for 90 days |
|
cardiac output will be calculated by multiplying stroke volume by heart rate. Cardiac index will be calculated by dividing cardiac output (Liters/minute) by body surface area (meters squared). Data will be collected at baseline and the end of treatment (90 days) |
| Baseline and 90 days |
| Change in Pulmonary Vascular Resistance | Pulmonary vascular resistance will be determined by right heart catheterization. Data will be collected at baseline and at the end of treatment (90 days) | Baseline and 90 days |
| Change in Blood Pressure | through standard cuff method, participants will have blood pressure measured to determine systolic and diastolic blood pressure as well as mean arterial pressure. data will be collected at baseline and 90 days. | Baseline and 90 days |
| Death |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sildenafil |
Sildenafil 20 mg three times per day, orally Sildenafil: 20 mg TID PO for 90 days |
|
|
|
| Other Pre-specified | Change in Right Ventricular Function | Right ventricular function will be measured using tricuspid annular plane systolic excursion via two dimensional apical four-chamber echocardiography. Data will be collected at baseline and after 90 days of treatment | Not Posted | Baseline and 90 day | Participants |
| Other Pre-specified | Change in Cardiac Output Relative to Body Surface Area (Cardiac Index) | cardiac output will be calculated by multiplying stroke volume by heart rate. Cardiac index will be calculated by dividing cardiac output (Liters/minute) by body surface area (meters squared). Data will be collected at baseline and the end of treatment (90 days) | Not Posted | Baseline and 90 days | Participants |
| Other Pre-specified | Change in Pulmonary Vascular Resistance | Pulmonary vascular resistance will be determined by right heart catheterization. Data will be collected at baseline and at the end of treatment (90 days) | Not Posted | Baseline and 90 days | Participants |
| Other Pre-specified | Change in Blood Pressure | through standard cuff method, participants will have blood pressure measured to determine systolic and diastolic blood pressure as well as mean arterial pressure. data will be collected at baseline and 90 days. | Not Posted | Baseline and 90 days | Participants |
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sildenafil | Sildenafil 20 mg three times per day, orally Sildenafil: 20 mg TID PO for 90 days | 1 | 17 | 0 | 17 | 0 | 17 |
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| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |