NCT02188862

Brief Summary

The purpose of this study is to investigate whether there are genetic differences between patients with rheumatic heart disease and members of the general population.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
3 countries

3 active sites

Status
completed

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 Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

July 10, 2014

Last Update Submit

July 14, 2014

Conditions

Rheumatic Heart DiseaseMitral Stenosis

Keywords

Rheumatic heart diseaseAcute rheumatic feverGroup A streptococcal diseaseStreptococcus pyogenesGeneticsOceania

Outcome Measures

Primary Outcomes (1)

  • Rheumatic heart disease diagnosis

    Diagnosis of rheumatic heart disease as layout in enrolment criteria for cases.

    At enrolment

Secondary Outcomes (1)

  • Mitral stenosis diagnosis

    At enrolment

Study Arms (2)

Rheumatic heart disease cases

Patients with rheumatic heart disease as defined in the case criteria

Population controls

Individuals from the general population divided into new controls (recruited specifically for this study) and existing controls (recruited to previous population genetics studies in the region)

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cases: * Prevalent and incident cases of rheumatic heart disease ascertained from disease registers, primary care clinics and hospital services. New Controls: * Individuals volunteering from communities where cases were identified. Existing Controls: * Individuals from this region who have previously been recruited to population genetics research studies.

You may qualify if:

  • Diagnosis of rheumatic heart disease based on one of:
  • World Heart Federation definite echocardiographic criteria
  • World Heart Federation borderline echocardiographic criteria and history of acute rheumatic fever
  • Mitral stenosis with valve area less than 2.0 cm2
  • Previous surgery for rheumatic heart disease

You may not qualify if:

  • Age less than five years
  • Inability to give consent
  • New Controls
  • Healthy individual living in a community where cases were identified
  • Past medical history or systems suggestive of rheumatic heart disease, acute rheumatic fever or other valvular heart disease
  • Age less than five years
  • Inability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Colonial War Memorial Hospital

Suva, Fiji

Location

Centre Hospitalier Territorial de Nouvelle Caledonie

Noumea, New Caledonia

Location

Wellcome Trust Centre for Human Genetics, University of Oxford

Oxford, OX3 7BN, United Kingdom

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood collected from all participants for extraction of DNA

MeSH Terms

Conditions

Rheumatic Heart DiseaseMitral Valve StenosisRheumatic FeverStreptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular DiseasesHeart Valve DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tom Parks, MRCP DTM&H

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Mariana Mirabel, MD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

  • Andrew C Steer, FRACP PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR

  • Adrian VS Hill, DPhil DM

    University of Oxford

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 14, 2014

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

NE(1)FI(1)GB(1)