NCT05991219

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Sep 2022Dec 2028

Study Start

First participant enrolled

September 26, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

6.3 years

First QC Date

August 6, 2023

Last Update Submit

August 12, 2023

Conditions

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Rheumatic heart disease

    Number of patients

    At the time of screening echocardiogram

Eligibility Criteria

Age10 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Age group 10-30 years. Screening in rural communities in Sindh including very low income areas outside Karachi. Schools (free government schools in low income areas) and patient point of contact locations such as National Institute of Cardiovascular Diseases Pakistan Satellite centers (10) and chest pain units (24) will also be utilized. Family members of patients with known rheumatic heart disease will also be screened.

You may qualify if:

  • Rural communities in Sindh

You may not qualify if:

  • Refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiovascular Diseases (NICVD)

Karachi, Sindh, 75510, Pakistan

RECRUITING

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic FeverStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular Diseases

Study Officials

  • Sabha Bhatti, MD

    National Institute of Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabha Bhatti, MD

CONTACT

+92 335 5554346drsabhabhatti@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 14, 2023

Study Start

September 26, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)