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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatic Heart Disease; Valvular Disease
• Intervention / Treatment: Drug: Atorvastatin; Drug: Placebo

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

• Study Contact: Name: Nona Sotoodehnia, MD, MPH; Phone Number: (206) 287-2777; Email: nsotoo@uw.edu
• Study Contact Backup: Name: Caitie Hawley, MSPH; Email: cnhawley@uw.edu

Study Locations

• Nepal
  • Kathmandu, Nepal
    • Manmohan Memorial Medical College & Teaching Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Statin arm; To receive pill packet with atorvastatin (40mg/day) which will be taken nightly.	Drug: Atorvastatin; Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.; Other Names: Statin
Placebo arm; To receive pill packet with placebo which will be taken nightly	Drug: Placebo; Participants in the control arm will receive a pill packet with placebo x 18 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Manmohan Cardiothoracic Vascular and Transplant Center
• Investigators: Principal Investigator: Nona Sotoodehnia, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Estimated): February 1, 2040
• Study Completion (Estimated): February 1, 2040

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Infections; Musculoskeletal Diseases; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Rheumatic Fever; Heart Diseases; Rheumatic Diseases; Rheumatic Heart Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: STUDY00008837; 5R34HL143279 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No