Rheumatic Heart DiseaseNCT05250154
Rheumatic Heart Disease Research and Screening in Nepal: A Feasibility Study
An observational study of Rheumatic Heart Disease, run by University of Washington at 1 site in Nepal.
Trial summary
Rheumatic Heart Disease (RHD) remains a significant public health problem in lower and middle-income countries, accounting for over 300,000 deaths world-wide. RHD is a sequela of Acute Rheumatic Fever (ARF) caused by Group A Streptococcus (GAS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatic Heart Disease
- How many people
- 2,438 participants
- Where
- 1 siteNepal
- Study dates
- 27 Aug 2018to 1 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Registry of RHD patients
Who may be able to join
- RHD patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Rheumatic Heart Disease (RHD) remains a significant public health problem in lower and middle-income countries, accounting for over 300,000 deaths world-wide. RHD is a sequela of Acute Rheumatic Fever (ARF) caused by Group A Streptococcus (GAS). Benzathine Penicillin Prophylaxis (BPP), through tri-weekly intramuscular injection of benzathine penicillin G, remains the mainstay of intervention to delay and prevent the sequelae among ARF and RHD patients by preventing repeat GAS infections. Two major obstacles exist to the optimal utilization of this effort. First, despite proven benefits, BPP adherence remains low. Unfortunately, there is very little knowledge on the factors associated with BPP adherence. Even in countries like Nepal, which has a nation-wide free BPP program serving about 6000 patients, there is absence of a robust system to prospectively track and study these patients. Second, largely because RHD is initially asymptomatic, only a fraction of those who would benefit are enrolled in BPP programs. There is a dearth of information and evidence on potentially high-yield approaches like the screening of first-degree relatives (FDRs) of RHD patients to identify asymptomatic, early-stage RHD patients who may benefit from BPP. The investigators will combine the resources and expertise at the University of Washington with those from existing partners at two leading Nepali hospitals (Manmohan Cardiothoracic Vascular and Transplant Center and Dhulikhel Hospital) to first create an easy to use, scalable, comprehensive electronic RHD registry and enroll BPP patients from these sites. In Aim 1, the investigators will examine whether patient socio-demographic, clinical, and health services-related characteristics are associated with BPP adherence. Investigators will use the BPP registry to collect important covariate information and adherence outcomes to address this aim. In Aim 2, investigators will determine the feasibility of screening FDRs of known RHD patients. Investigators will invite FDRs of known RHD patients (enrolled in the BPP registry) for echocardiographic screening for RHD. Investigators will assess the prevalence of RHD in these FDRs. This proposal harnesses one of the largest RHD patient pools in the world for establishing a robust RHD-related quality improvement and research platform that serves as a solid foundation for conducting larger epidemiologic, interventional, and implementation studies on RHD risk, prevention, and treatment.
- Conditions
- Rheumatic Heart Disease
- Medical subject headings
- Rheumatic Heart Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of rheumatic heart disease valve measured using standard imaging protocols
We will use standard imaging protocols to evaluate mitral, aortic, and tricuspid valves, which will allow analysis according to the World Heart Federation criteria for echocardiographic diagnosis of RHD among adults
Measured: 20 years
Adherence to BPP measured using proportion of days covered.
The BPP clinic staff will enter information on injection every three weeks and will make a note of any clinical events during the preceding 3 weeks as reported by the patients. We will prospectively follow for one year all patients recruited in the first six weeks. At one year, we will assess the adherence to BPP. We will measure adherence using the proportion of days covered (PDC). PDC, a commonly used pharmacy quality measure for oral medications, has been adapted for injectable BPG in prior reports.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start27 Aug 2018
- Primary completion1 May 2040 (estimated)
- Study completion1 May 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
- 2,438 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Fogarty International Center of the National Institute of Health
- 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
- NCT05250154
- Sponsor's protocol ID
- STUDY00005371
- Other IDs
- R34HL143279, R21TW011108
- Status last verified
- Jun 2023
- First submitted
- 18 Oct 2021
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Rheumatic Heart Disease Research and Screening in Nepal: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05250154
- Acronym / sponsor ID
- STUDY00005371
- Conditions
- Rheumatic Heart Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,438 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Fogarty International Center of the National Institute of Health
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 1 May 2040 (estimated)
- Study completion
- 1 May 2040 (estimated)
- First posted
- 22 Feb 2022 (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.
Rheumatic Heart Disease (RHD) remains a significant public health problem in lower and middle-income countries, accounting for over 300,000 deaths world-wide. RHD is a sequela of Acute Rheumatic Fever (ARF) caused by Group A Streptococcus (GAS). Benzathine Penicillin Prophylaxis (BPP), through tri-weekly intramuscular injection of benzathine penicillin G, remains the mainstay of intervention to delay and prevent the sequelae among ARF and RHD patients by preventing repeat GAS infections. Two major obstacles exist to the optimal utilization of this effort. First, despite proven benefits, BPP adherence remains low. Unfortunately, there is very little knowledge on the factors associated with BPP adherence. Even in countries like Nepal, which has a nation-wide free BPP program serving about 6000 patients, there is absence of a robust system to prospectively track and study these patients. Second, largely because RHD is initially asymptomatic, only a fraction of those who would benefit are enrolled in BPP programs. There is a dearth of information and evidence on potentially high-yield approaches like the screening of first-degree relatives (FDRs) of RHD patients to identify asymptomatic, early-stage RHD patients who may benefit from BPP. The investigators will combine the resources and expertise at the University of Washington with those from existing partners at two leading Nepali hospitals (Manmohan Cardiothoracic Vascular and Transplant Center and Dhulikhel Hospital) to first create an easy to use, scalable, comprehensive electronic RHD registry and enroll BPP patients from these sites. In Aim 1, the investigators will examine whether patient socio-demographic, clinical, and health services-related characteristics are associated with BPP adherence. Investigators will use the BPP registry to collect important covariate information and adherence outcomes to address this aim. In Aim 2, investigators will determine the feasibility of screening FDRs of known RHD patients. Investigators will invite FDRs of known RHD patients (enrolled in the BPP registry) for echocardiographic screening for RHD. Investigators will assess the prevalence of RHD in these FDRs. This proposal harnesses one of the largest RHD patient pools in the world for establishing a robust RHD-related quality improvement and research platform that serves as a solid foundation for conducting larger epidemiologic, interventional, and implementation studies on RHD risk, prevention, and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Registry of RHD patients
Key inclusion criteria (1 listed)
- RHD patients
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression of rheumatic heart disease valve measured using standard imaging protocols
Time frame: 20 years
We will use standard imaging protocols to evaluate mitral, aortic, and tricuspid valves, which will allow analysis according to the World Heart Federation criteria for echocardiographic diagnosis of RHD among adults
Adherence to BPP measured using proportion of days covered.
Time frame: 20 years
The BPP clinic staff will enter information on injection every three weeks and will make a note of any clinical events during the preceding 3 weeks as reported by the patients. We will prospectively follow for one year all patients recruited in the first six weeks. At one year, we will assess the adherence to BPP. We will measure adherence using the proportion of days covered (PDC). PDC, a commonly used pharmacy quality measure for oral medications, has been adapted for injectable BPG in prior reports.
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.
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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, 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 1 inclusion and 1 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?
Progression of rheumatic heart disease valve measured using standard imaging protocols (time frame: 20 years). The study lists 2 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.