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NCT Number: NCT04575857

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Manmohan Memorial Medical College & Teaching Hospital.

Kathmandu, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

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

Other names: Statin

Placebo

Drug

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

Primary outcomes

  1. Enrollment rate

    Time frame: Measured at study enrollment

    Defined as the proportion of approached eligible participants who consent to enroll in the study

  2. Medication adherence

    Time frame: Measured at month 1

    The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken

  3. Medication adherence

    Time frame: Measured at months 6

    The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken

  4. Medication adherence

    Time frame: Measured at months 12

    The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken

  5. Medication adherence

    Time frame: Measured at months 18

    The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken

  6. Retention rate

    Time frame: Measured at Month 18

    Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion

  7. Rate of progression of valvular disease

    Time frame: Change between baseline and Month 18

    Compare month 18 echocardiogram with baseline echocardiogram

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Manmohan Cardiothoracic Vascular and Transplant Center
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2040
Study completion
2040
First posted
Oct 5, 2020
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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