Rheumatic Heart DiseaseNCT04575857
Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression
An observational study of Rheumatic Heart Disease and Valvular Disease, run by University of Washington at 1 site in Nepal.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatic Heart Disease, Valvular Disease
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNepal
- Study dates
- 8 Feb 2022to Feb 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 18 years
- History of RHD as evidenced by at least one echocardiographic examination
- No history of cardiac surgery
Who cannot join
- ≥ 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rheumatic Heart Disease, Valvular Disease
- Being tested
- Atorvastatin, Placebo
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Statin
Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.
PlaceboDrug
Participants in the control arm will receive a pill packet with placebo x 18 months.
| Study group | Role | What they receive |
|---|---|---|
| Statin arm | To receive pill packet with atorvastatin (40mg/day) which will be taken nightly. Receives: Drug: Atorvastatin | |
| Placebo arm | To receive pill packet with placebo which will be taken nightly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Defined as the proportion of approached eligible participants who consent to enroll in the study
Measured: 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: 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: 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: 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: Measured at months 18
Retention rate
Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion
Measured: Measured at Month 18
Rate of progression of valvular disease
Compare month 18 echocardiogram with baseline echocardiogram
Measured: Change between baseline and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start8 Feb 2022
- Primary completionFeb 2040 (estimated)
- Study completionFeb 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Manmohan Cardiothoracic Vascular and Transplant Center, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Nona Sotoodehnia, University of Washington
- Investigators
- Nona Sotoodehnia, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575857
- Sponsor's protocol ID
- STUDY00008837
- Other IDs
- 5R34HL143279
- Status last verified
- Jun 2023
- First submitted
- 23 Sep 2020
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study For A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04575857
- Acronym / sponsor ID
- STUDY00008837
- Conditions
- Rheumatic Heart Disease, Valvular Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Manmohan Cardiothoracic Vascular and Transplant Center, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- Feb 2040 (estimated)
- Study completion
- Feb 2040 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin arm | – | Drug: AtorvastatinTo receive pill packet with atorvastatin (40mg/day) which will be taken nightly. |
| Placebo arm | – | Drug: PlaceboTo receive pill packet with placebo which will be taken nightly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- ≥ 18 years
- History of RHD as evidenced by at least one echocardiographic examination
- No history of cardiac surgery
Key exclusion criteria (7 listed)
- ≥ 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: StatinParticipants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months. | Drug | Statin arm |
| PlaceboParticipants in the control arm will receive a pill packet with placebo x 18 months. | Drug | Placebo arm |
Primary outcome
Enrollment rate
Time frame: Measured at study enrollment
Defined as the proportion of approached eligible participants who consent to enroll in the study
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
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
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
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
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
Rate of progression of valvular disease
Time frame: Change between baseline and Month 18
Compare month 18 echocardiogram with baseline echocardiogram
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nona Sotoodehnia, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Heart Disease and Valvular Disease, run by University of Washington at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: Measured at study enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.