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The purpose of this study is to assess the efficacy of sacubitril-valsartan compared to the combination of ARB/CCB on left ventricular remodeling in patients with chronic aortic valve regurgitation.
After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to sacubitril-valsartan or amlodipine/losartan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacubitril-Valsartan Group | Active Comparator | Participant start Sacubitril/Valsartan tablet 50mg twice a day and uptitrate to 100mg twice a day. Participants take the maximum dose considering blood pressure for a total of 48 weeks. |
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| Amlodipine-Losartan group | Placebo Comparator | Participant start amlodipine/losartan 25/2.5mg once a day and uptitrate to 5/100mg once a day. Participants take the maximum dose considering blood pressure for a total of 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril-valsartan | Drug | 50mg~100mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of left ventricular end-diastolic volume index from baseline to 12 months follow-up | Change = [LVEDV on CMR at 12 months]-[LVEDV on CMR at baseline] | Baseline and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of regurgitant volume of aortic valve regurgitation from baseline to 12 months follow-up. | Change = [regurgitant volume at 12 months]-[regurgitant volume at baseline] | Baseline and month 12 |
| Change of EROA of aortic valve regurgitation from baseline to 12 months follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Kyoung Kim, MD. PhD | Contact | 82-2-3410-3419 | ekbobi.kim@samsung.com | |
| Sung Ji Park, MD, PhD | Contact | 82-2-3410-3419 | sungji.park@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Eun Kyoung Kim, MD, PhD | Heart Vascular Stroke Institute, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| C000710253 | amlodipine-losartan drug combination |
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| Amlodipine-losartan | Drug | amlodipine/losartan 2.5/25mg ~ 5/100mg once daily |
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Measurement of regurgitant volume of AR is derived from Doppler imaging on echocardiography. Change = [regurgitant volume at 12 months]-[regurgitant volume at baseline] |
| Baseline and month 12 |
| Change of LV end-systolic volume from baseline to 12 months follow-up. | Change = [LVEDV at 12 months]-[LVEDV at baseline] | Baseline and month 12 |
| Holodiastolic flow reversal in the proximal abdominal aorta and descending thoracic aorta from baseline to 12 months follow-up | presence or absence of holodiastolic flow reversal in the proximal abdominal and descending thoracic aorta on echocardiography | Baseline and month 12 |
| Change of NT-proBNP level from baseline to 12 months follow-up. | Change =[NT-proBNP at 12 months]-[NTproBNP at baseline] | Baseline and month 12 |
| Aortic valve replacement or repair operation | Any surgical event for correction of AR | During 12 months after enrollment |