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| ID | Type | Description | Link |
|---|---|---|---|
| 1UL1TR002373-01 | U.S. NIH Grant/Contract | View source | |
| A534285 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/PULMON MED | Other Identifier | UW Madison | |
| Protocol Version 8/30/2018 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.
The purpose of this study is to evaluate the short-term therapeutic effects of sildenafil and metoprolol on right ventricular function in young adults born premature using novel 4-Dimensional flow Cardiac Magnetic Resonance Imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil followed by Metoprolol | Experimental | Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram. |
|
| Metoprolol followed by Sildenafil | Experimental | Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given metoprolol in between imaging scans at one visit, and will receive intravenous sildenafil in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Function Testing | Procedure | Subjects will undergo spirometry, Plethysmography, and diffusion capacity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Right Ventricular Energetic Efficiency Pre and Post Metoprolol | To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Metoprolol intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours. | up to 2 hours |
| Right Ventricular Energetic Efficiency Pre and Post Sildenafil | To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Sildenafil intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours. | up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Energetic Efficiency Pre and Post Metoprolol | Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will receive intravenous metoprolol in between scans. | up to 2 hours |
| Right Ventricular Ejection Fraction Pre and Post Metoprolol |
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Inclusion Criteria:
Provision of signed and dated informed consent form
Male or female aged 18-35
History of preterm birth (either a or b):
Exclusion Criteria:
Pregnant or lactating
Use of prescribed medications that would interfere with study medications
Presence of known comorbidities for which these therapeutic interventions would be contraindicated:
Presence of any implanted device incompatible with CMR imaging
Known allergic or hypersensitivity reaction to components of the study medications
Any other reason for which the investigator deems a subject unsafe or inappropriate for study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Kara N Goss, MD | University of Wisconsin-Madison School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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Due to COVID shut down, 1 participant was excluded from the study before assignment to groups
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil Followed by Metoprolol | Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram. |
| FG001 | Metoprolol Followed by Sildenafil | Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given metoprolol in between imaging scans at one visit, and will receive intravenous sildenafil in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Wash Out>12 Hours |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Young Adults Born Premature | Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. Subjects will also undergo pulmonary function testing and electrocardiogram. Pulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity. Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally) |
| 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 | Right Ventricular Energetic Efficiency Pre and Post Metoprolol | To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Metoprolol intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours. | Posted | Mean | Standard Deviation | µJ/ml | up to 2 hours |
|
3 months
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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 | Sildenafil Followed by Metoprolol | Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram. Pulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity. Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kara Goss | UT Southwestern, Dallas, Texas | 214-648-6868 | kara.goss@utsouthwestern.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 | Aug 30, 2018 | Jan 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D008790 | Metoprolol |
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
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Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out.
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| Electrocardiogram | Procedure | Subjects will undergo an electrocardiogram to ensure sinus rhythm |
|
| Cardiac Magnetic Resonance Imaging | Procedure | Subjects will undergo positron magnetic resonance imaging to detect images of the heart |
|
| Metoprolol | Drug | Subjects will receive intravenous metoprolol. Dose titrated 1-5 mg every 2 minutes to achieve goal heart rate of 55-65 beats per minute, or for subjects with a resting heart rate already at goal, titrated to achieve a 10-15% reduction in heart rate. |
|
|
| Sildenafil | Drug | Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally) |
|
|
Participants will receive intravenous metoprolol in between scans. |
| up to 2 hours |
| Right Ventricular Stroke Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | up to 2 hours |
| Right Ventricular Systolic Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | up to 2 hours |
| Right Ventricular Diastolic Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | up to 2 hours |
| Left Ventricular Ejection Fraction Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | up to 2 hours |
| Left Ventricular Stroke Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | up to 2 hours |
| Left Ventricular Systolic Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | up to 2 hours |
| Left Ventricular Diastolic Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | up to 2 hours |
| Left Ventricular Energetic Efficiency Pre and Post Sildenafil | Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will be given sildenafil in between imaging scans. | up to 2 hours |
| Right Ventricular Ejection Fraction Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. The term "ejection fraction" refers to the percentage of blood that's pumped out of a filled ventricle with each heartbeat. | up to 2 hours |
| Right Ventricular Stroke Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | up to 2 hours |
| Right Ventricular Systolic Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | up to 2 hours |
| Right Ventricular Diastolic Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | up to 2 hours |
| Left Ventricular Ejection Fraction Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | up to 2 hours |
| Left Ventricular Stroke Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | up to 2 hours |
| Left Ventricular Systolic Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | up to 2 hours |
| Left Ventricular Diastolic Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | up to 2 hours |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| 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 |
|
| Gestational age (Neonatal Characteristics) | Mean | Standard Deviation | Weeks |
|
| Birth weight (Neonatal Characteristics) | Mean | Standard Deviation | gram |
|
|
|
|
| Primary | Right Ventricular Energetic Efficiency Pre and Post Sildenafil | To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Sildenafil intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours. | Posted | Mean | Standard Deviation | µJ/ml | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Energetic Efficiency Pre and Post Metoprolol | Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will receive intravenous metoprolol in between scans. | Posted | Mean | Standard Deviation | µJ/ml | up to 2 hours |
|
|
|
|
| Secondary | Right Ventricular Ejection Fraction Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | Posted | Mean | Standard Deviation | percentage | up to 2 hours |
|
|
|
|
| Secondary | Right Ventricular Stroke Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Right Ventricular Systolic Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Right Ventricular Diastolic Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Ejection Fraction Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | Posted | Mean | Standard Deviation | percentage | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Stroke Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Systolic Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Diastolic Volume Pre and Post Metoprolol | Participants will receive intravenous metoprolol in between scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Energetic Efficiency Pre and Post Sildenafil | Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will be given sildenafil in between imaging scans. | Posted | Mean | Standard Deviation | µJ/ml | up to 2 hours |
|
|
|
|
| Secondary | Right Ventricular Ejection Fraction Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. The term "ejection fraction" refers to the percentage of blood that's pumped out of a filled ventricle with each heartbeat. | Posted | Mean | Standard Deviation | percentage | up to 2 hours |
|
|
|
|
| Secondary | Right Ventricular Stroke Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Right Ventricular Systolic Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Right Ventricular Diastolic Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Ejection Fraction Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | Posted | Mean | Standard Deviation | percentage | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Stroke Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Systolic Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| Secondary | Left Ventricular Diastolic Volume Pre and Post Sildenafil | Participants will be given sildenafil in between imaging scans. | Posted | Mean | Standard Deviation | ml/m^2 | up to 2 hours |
|
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Metoprolol Followed by Sildenafil | Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given metoprolol in between imaging scans at one visit, and will receive intravenous sildenafil in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D000091642 | Urogenital Diseases |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |