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

NCT04575857 | Active Not Recruiting DMC

• 2 other identifiers: STUDY000088375R34HL143279
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatic Heart Disease; Valvular Disease

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Statin arm

To receive pill packet with atorvastatin (40mg/day) which will be taken nightly.

Drug: Atorvastatin

Placebo arm

To receive pill packet with placebo which will be taken nightly

Drug: Placebo

Interventions

Atorvastatin DRUG

Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.

Also known as: Statin

Statin arm

Placebo DRUG

Participants in the control arm will receive a pill packet with placebo x 18 months.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• ≥ 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

Sponsors & Collaborators

• University of Washington: lead
• Manmohan Cardiothoracic Vascular and Transplant Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Manmohan Memorial Medical College & Teaching Hospital.

Kathmandu, Nepal

Location

MeSH Terms

Conditions

Rheumatic Heart Disease

Interventions

Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Nona Sotoodehnia, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Cardiovascular Health Research Unit

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 5, 2020
• Study Start: February 8, 2022
• Primary Completion (Estimated): February 1, 2040
• Study Completion (Estimated): February 1, 2040
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)