Rheumatic Heart Disease

13

Review clinical trials related to Rheumatic Heart Disease. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda

This study aims to improve follow-up care after positive rheumatic heart disease (RHD) screening in Northern Uganda. It will identify barriers and co-develop an enhanced ACT+ strategy, then evaluate its effectiveness in increasing linkage to confirmatory echocardiography, along with its adoption, acceptability, and feasibility. Secondary outcomes include time to diagnosis, initiation of treatment, and factors influencing implementation.

Participants needed: 16
Trial details
Biological sex: AllType: InterventionalSponsor: Children's Hospital Medical Center, CincinnatiUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

18 years of age or older [+10]

No formal exclusion criteria beyond inability to provide informed consent. Indiv...

Status: Recruiting

A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop

GOAL-Stop is a randomized, controlled, non-inferiority trial designed to evaluate whether discontinuing secondary antibiotic prophylaxis (SAP) is non-inferior to continuing SAP in preventing progression of rheumatic heart disease (RHD) among children and adolescents. The trial will enroll participants aged 5-20 years with previously diagnosed mild RHD who have received at least 2 years of SAP and who demonstrate either echocardiographic normalization or stability (persistent mild RHD). Participants will be randomized to either continue SAP or discontinue SAP for 2 years. The primary outcome is echocardiographic progression of RHD at 2 years, assessed by blinded adjudicators using the 2023 World Heart Federation criteria. Subgroup analyses will evaluate outcomes in participants with echocardiographic normalization versus stable mild RHD, and an exploratory analysis will assess whether outcomes differ by prior prophylaxis route (oral vs. intramuscular).

Participants needed: 922
Trial details
Phase: Phase 3Age: 5-20Biological sex: AllType: InterventionalSponsor: Children's Hospital Medical Center, CincinnatiUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

Participated in GOALIE [+2]

RHD Stage C/D at GOALIE end of study echocardiogram [+2]

Status: Not yet recruiting

Artificial Intelligence to Scale Early Rheumatic Heart Disease Detection

The main goal of this project is to see if RADAR (Rapid AI-assisted Detection and Analysis of Rheumatic heart disease), which is a machine and deep-learning AI model, can help make rheumatic heart disease (RHD) screening easier to expand. Specifically, the project will test whether RADAR can screen as accurately-or more accurately-than current methods, and whether it can be used effectively in different low-resource settings. The aim is to show that RADAR could be adopted and used widely around the world.

Participants needed: 62
Trial details
Biological sex: AllType: InterventionalSponsor: Children's Hospital Medical Center, CincinnatiUpdated: May 27, 2026Locations: 1
Eligibility criteria

Employed at a participating ADUNU facility [+1]

None. The pragmatic trial design includes all eligible staff at participating fa...

Status: Not yet recruiting

Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda

This study aims to improve follow-up care after positive rheumatic heart disease (RHD) screening in Northern Uganda. It will identify barriers and co-develop an enhanced ACT+ strategy, then evaluate its effectiveness in increasing linkage to confirmatory echocardiography, along with its adoption, acceptability, and feasibility. Secondary outcomes include time to diagnosis, initiation of treatment, and factors influencing implementation.

Participants needed: 16
Trial details
Biological sex: AllType: InterventionalSponsor: Children's Hospital Medical Center, CincinnatiUpdated: May 26, 2026Locations: 1
Eligibility criteria

18 years of age or older [+10]

No formal exclusion criteria beyond inability to provide informed consent. Indiv...

Status: Recruiting

Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda

The goal of this prospective study is to evaluate the feasibility, sustainability, and public health impact of a district-based program for secondary prevention of Rheumatic Heart Disease (RHD) in Uganda.

Participants needed: 221
Trial details
Age: 5+Biological sex: AllType: InterventionalSponsor: Children's Hospital Medical Center, CincinnatiUpdated: May 15, 2026Locations: 1
Eligibility criteria

residing in one of two involved districts in Uganda [+1]

None

Status: Not yet recruiting

Clinical Trial Phase I/IIa to Evaluate the Safety and Immunogenicity of StreptInCor

This is a Phase I/IIa, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to test the candidate vaccine StreptInCor. The study will include four different doses (25 µg, 50 µg, 100 µg, and 200 µg) of StreptInCor produced under Good Manufacturing Practices (GMP) and formulated with aluminum hydroxide as the vaccine adjuvant. The adjuvant alone will be used as a placebo in this trial. Five groups, each consisting of twelve healthy adult volunteers, will randomly receive two doses of the vaccine or placebo with a 28-day interval, along with a booster dose six months after the initial vaccination

Participants needed: 60
Trial details
Phase: Phase 1, Phase 2Age: 18-45Biological sex: AllType: InterventionalSponsor: University of Sao Paulo General HospitalUpdated: Jul 22, 2025Locations: 1
Eligibility criteria

• Healthy male or female volunteers, aged between 18 and 45 years; [+2]

Participation in clinical trials within the last year [+15]

Status: Not yet recruiting

Effectiveness of Edutainment-Based Interventions in Increasing Knowledge of Rheumatic Fever and Rheumatic Heart Disease Among School-Going Children in Nepal: Study Protocol for Colors to Save Hearts Quasi-Experimental Pretest-Posttest Study

Background: Acute rheumatic fever (ARF) and its sequela, rheumatic heart disease (RHD), remain significant public health concerns in low- and middle-income countries, including Nepal. Despite their preventable nature, awareness of ARF and RHD among schoolchildren is limited. Innovative, age-appropriate health education strategies are urgently needed to promote early recognition and prevention. Objective: This study aims to evaluate the effectiveness of an edutainment-based intervention in improving knowledge of ARF and RHD among school-going children in Nepal. Methods: A quasi-experimental pretest-posttest study design with a waitlist control group will be employed across 24 public schools in six diverse districts. A total of 2,400 students from Grades 6 to 9 will be included. The intervention integrates creative educational tools-coloring books, activity books, storytelling, videos, and interactive sessions-tailored to different age groups. Knowledge change will be measured using a validated questionnaire administered at baseline and post-intervention. Secondary outcomes include the prevalence of RHD-related symptoms assessed through clinical screening. Expected Outcomes: It is hypothesized that students in the intervention group will demonstrate a statistically significant improvement in knowledge scores compared to their baseline levels and the control group. The study will also assess the feasibility and acceptability of the intervention and inform recommendations for broader school-based health education programs. Conclusion: This study addresses a critical gap in child health education in Nepal using an innovative, scalable approach. Findings will contribute to the evidence base for integrating edutainment into school curricula to combat preventable diseases like RHD in resource-limited settings.

Participants needed: 2,400
Trial details
Age: 10-18Biological sex: AllType: InterventionalSponsor: Kathmandu Institute of Child HealthUpdated: Jul 15, 2025Locations: 1
Eligibility criteria

Students will be eligible for inclusion in the study if they are formally enroll...

Students will be excluded from the study if they or their guardians decline to p...

Status: Not yet recruiting

Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice

Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making. South Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.

Participants needed: 30,000
Trial details
Age: 19+Biological sex: AllType: ObservationalSponsor: Yonsei UniversityUpdated: Jul 16, 2025Locations: 1
Eligibility criteria

Period: 2010.1.1~2020.12.31 [+3]

Poor image of echocardiography [+1]

Status: Recruiting

The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa

In this bi-directional program of education, training and research activities based on sustainable development goals aim is to develop cardiac surgery service in Ethiopia. The aim is to evaluate the short and long-term outcome of cardiac surgery for rheumatic heart disease in a low-income country compared to individuals not offered cardiac surgery due to limited availability of the service. Second aim is to evaluate the quality of anticoagulant therapy in patients after cardiac surgery for rheumatic heart disease in a low-income country .

Participants needed: 200
Trial details
Age: 14+Biological sex: AllType: ObservationalSponsor: Helse Nord-Trøndelag HFUpdated: Jun 12, 2025Locations: 4
Eligibility criteria

Cardiac surgery due to rheumatic heart disease at the governmental Black Lion Un...

Not willing or able to provide written informed consent

Status: Recruiting

Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE

Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC). Current guideline recommends percutaneous balloon mitral valvuloplasty (PBMV) being the first line intervention for rheumatic MS with favorable anatomy. However, severely calcified mitral valve (i.e. those with Wilkins scores\>8) makes the mitral valve non-pliable and carries high risk of severe mitral regurgitation (MR) (4-19%) with conventional balloon valvuloplasty. MAC is an increasingly recognized disease associated with atherosclerotic risk factors, and a well-recognized valve morphology that responses poorly with PBMV. Besides, conventional open-heart surgery for MAC-associated mitral valve dysfunction carries high mortality. Transcatheter mitral valve replacement with valve-in-MAC has become an alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality. Intravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated. SmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.

Participants needed: 10
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Prince of Wales Hospital, Shatin, Hong KongUpdated: Apr 30, 2025Locations: 1
Eligibility criteria

Age >18 and [+4]

Baseline > moderate MR [+4]

Status: Recruiting

Screening and Secondary Prevention Rheumatic Heart Disease Study

After basic clinical screening including history and physical, Point of care ultrasound will be performed to look at Mitral, Aortic and Tricuspid Valves for regurgitation or stenosis. For patients with confirmed Rheumatic heart disease (RHD), treatment and referral depending on stage of disease. Antibiotic prescription could be shifted to community health workers delivering preventive medications via practical clinical algorithms, diagnostic tools, availability of appropriate antibiotics, and supportive supervision. Patients will have repeat imaging at 2 years and 5 years to look at the outcome of delayed progression of valve disease.

Participants needed: 5,000
Trial details
Age: 10-30Biological sex: AllType: ObservationalSponsor: National Institute of Cardiovascular Diseases, PakistanUpdated: Aug 15, 2023Locations: 1
Eligibility criteria

Rural communities in Sindh

Refused to participate in the study

Status: Recruiting

Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease

The overall objective is to evaluate the effectiveness of a school-centered primary and secondary prevention program on the prevalence of latent rheumatic heart disease among schoolchildren in Nepal, and to investigate the role of socioeconomic and environmental factors in the development and progression of rheumatic heart disease.

Participants needed: 2,300
Trial details
Age: 5-16Biological sex: AllType: InterventionalSponsor: Insel Gruppe AG, University Hospital BernUpdated: Aug 17, 2022Locations: 1
Eligibility criteria

Age 5-16 years [+1]

Children / primary caregivers not providing informed consent to participate [+1]