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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34HL143279 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Manmohan Cardiothoracic Vascular and Transplant Center | UNKNOWN |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this study is to address specific implementation questions necessary and sufficient to ensure the feasibility of the larger randomized trial examining the efficacy of statin medications in slowing rheumatic heart disease (RHD) valvular pathology progression. This feasibility study is intended to confirm the number of readily recruitable subjects, assess recruitment rate, and assess the rate of valve pathology via echocardiograms. These results are necessary and sufficient to facilitate the successful design of a large full scale randomized trial to determine whether statins improve outcomes in RHD. Successful treatment of RHD would fundamentally shift the RHD management paradigm world-wide, improve the lives of millions afflicted with RHD, and subsequently, decrease health care spending on RHD management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin arm | To receive pill packet with atorvastatin (40mg/day) which will be taken nightly. |
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| Placebo arm | To receive pill packet with placebo which will be taken nightly |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | Defined as the proportion of approached eligible participants who consent to enroll in the study | Measured at study enrollment |
| Medication adherence | The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken | Measured at month 1 |
| Medication adherence | The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken | Measured at months 6 |
| Medication adherence | The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken | Measured at months 12 |
| Medication adherence | The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken | Measured at months 18 |
| Retention rate | Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion | Measured at Month 18 |
| Rate of progression of valvular disease | Compare month 18 echocardiogram with baseline echocardiogram | Change between baseline and Month 18 |
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Inclusion Criteria:
Exclusion Criteria:
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We have developed a comprehensive electronic database of RHD/RF patients in Nepal which will serve as the main data collection and participant recruitment mechanism.
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| Name | Affiliation | Role |
|---|---|---|
| Nona Sotoodehnia, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manmohan Memorial Medical College & Teaching Hospital. | Kathmandu | Nepal |
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| ID | Term |
|---|---|
| D012214 | Rheumatic Heart Disease |
| ID | Term |
|---|---|
| D012213 | Rheumatic Fever |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Participants in the control arm will receive a pill packet with placebo x 18 months. |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |