Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression

Rheumatic Heart Disease Clinical Trial

Official title:

Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study For A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04575857
• Other study ID #: STUDY00008837
• Secondary ID: 5R34HL143279
• Status: Active, not recruiting
• Start date: February 8, 2022
• Est. completion date: February 2040

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 2040
• Est. primary completion date: February 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• = 18 years
• History of RHD as evidenced by at least one echocardiographic examination
• No history of cardiac surgery

Exclusion Criteria:

• = 75 or < 18 years old
• Absence of RHD or RF history
• Active liver disease
• Impaired hepatic and renal function, including unexplained elevated levels of alanine transaminase greater than twice the upper limit of normal
• History of previous statin intolerance or muscle disorders
• Current pregnancy (by history or lab assessment of beta hCG) or plans for pregnancy in the next 18 months). Current lactation / breast feeding.
• LDL <60

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease
• Valvular Disease

Intervention

Drug:
• Atorvastatin
Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.
• Placebo
Participants in the control arm will receive a pill packet with placebo x 18 months.

Locations

Country	Name	City	State
Nepal	Manmohan Memorial Medical College & Teaching Hospital.	Kathmandu

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Manmohan Cardiothoracic Vascular and Transplant Center, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate	Defined as the proportion of approached eligible participants who consent to enroll in the study	Measured at study enrollment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Retention rate	Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion	Measured at Month 18
Primary	Rate of progression of valvular disease	Compare month 18 echocardiogram with baseline echocardiogram	Change between baseline and Month 18