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| ID | Type | Description | Link |
|---|---|---|---|
| K23GM112014 | U.S. NIH Grant/Contract | View source |
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Study funding ended before recruitment completed.
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Heart failure with preserved ejection fraction (HFpEF), is one of the leading causes of pulmonary hypertension (PH). Despite the severity of this disease, no established treatments exist for this class of PH. Nebivolol is a drug used in high blood pressure and heart failure, but not used in patients with PH. Due to some additional properties it possesses, the investigators believe nebivolol will improve disease severity in patients with PH associated with HFpEF. The hypothesis of this research study is that nebivolol improves PH severity in patients with HFpEF, as measured by hemodynamic and clinical parameters.
This research study will be a prospective, open-label 18-week clinical study of nebivolol in patients with PH associated with HFpEF. Patients will be identified in clinic based on echocardiogram (TTE) and right heart catheterization (RHC) results (both part of standard clinical care) indicating PH and HFpEF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebivolol | Experimental | Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pulmonary Vascular Pressure | Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure | baseline - 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 6-minute Walk Distance | Difference in 6-minute walk distance between baseline and 18 weeks. | baseline - 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio Duarte, PharmD, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebivolol | Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol | Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Changes in Pulmonary Vascular Pressure | Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure | Posted | Mean | Standard Deviation | mmHg | baseline - 18 weeks |
|
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Data were collected from enrollment until completion of final study visit at week 18.
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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 | Nebivolol | Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. Nebivolol: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
Trial was stopped prior to completion because funding ended.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julio Duarte | University of Florida | 352-273-8132 | juliod@cop.ufl.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 | Oct 8, 2018 | Jan 19, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2019 | Jan 19, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | 2 patients withdrew before measurement | Mean | Standard Deviation | kilograms |
|
| Height | 2 patients withdrew before measurement | Mean | Standard Deviation | cm |
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| Systolic Blood Pressure | 2 patients withdrew before measurement | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | 2 patients withdrew before measurement | Mean | Standard Deviation | mmHg |
|
| Mean Pulmonary Artery Pressure | 2 patients withdrew before measurement | Mean | Standard Deviation | mmHg |
|
| Pulmonary Artery Wedge Pressure | 2 patients withdrew before measurement | Mean | Standard Deviation | mmHg |
|
|
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| Secondary | Changes in 6-minute Walk Distance | Difference in 6-minute walk distance between baseline and 18 weeks. | Only patients who were able to complete walk tests at baseline and final study visits. | Posted | Mean | Standard Deviation | feet | baseline - 18 weeks |
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|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 2 |
| 9 |
| Fluid retention | Renal and urinary disorders | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |