Clinical trial NCT04575857: Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression
Official title: Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study For A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatic Heart Disease
Valvular Disease
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Manmohan Cardiothoracic Vascular and Transplant Center
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Enrollment rate
timeFrame: Measured at study enrollment
measure: Medication adherence
timeFrame: Measured at month 1
measure: Medication adherence
timeFrame: Measured at months 6
measure: Medication adherence
timeFrame: Measured at months 12
measure: Medication adherence
timeFrame: Measured at months 18
measure: Retention rate
timeFrame: Measured at Month 18
measure: Rate of progression of valvular disease
timeFrame: Change between baseline and Month 18
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Manmohan Memorial Medical College & Teaching Hospital.
Study officials:
affiliation: University of Washington
name: Nona Sotoodehnia, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: