Rheumatic Heart DiseasePhase 2/3ASEF-VALUESNCT02881398
Mobile Health in Structural Heart Disease
A Phase 2/3 study testing mHealth and Standard-Care in people with Rheumatic Heart Disease and Heart Diseases, run by Sri Sathya Sai Institute of Higher Medical Sciences.
Trial summary
The primary objective of this investigation was to assess the impact of new mobile health devices on health outcomes among patients with rheumatic and structural heart disease in a resource limited area. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Rheumatic Heart Disease, Heart Diseases
- What is being tested?
- mHealth and Standard-Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jan 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic outpatients with a new or an established diagnosis of rheumatic and structural heart disease and included valvular disease, left/right ventricular failure, rheumatic valvular disease, congenital heart defects and included adult, pediatric, and pregnant patients. Patients with a prior valvuloplasty or valve replacement for structural heart disease were also included
Who cannot join
- Exclusions included neonatal patients and those with an unstable hemodynamic status
About this study
Official title: A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics
The primary objective of this investigation was to assess the impact of new mobile health devices on health outcomes among patients with rheumatic and structural heart disease in a resource limited area. To achieve this aim the investigators utilized smartphone-connected devices such as the smartphone-ECG, activity monitors, connected blood pressure devices and pocket-sized and handheld ultrasound. The main question asked in this investigation is if mobile health assessments accelerates medical-decision-making and if it shortens the time to definitive therapy.
Read the detailed description
A recent paradigm-shift in the global burden of cardiovascular diseases has been observed with a decreasing prevalence in industrialized nations and an increasing prevalence in resource limited areas. This problem is further compounded with resource-limited areas receiving a disproportionately low allocation of global resources including diagnostic tests and trained healthcare professionals. Such cardiovascular conditions include heart failure, coronary artery disease, atrial arrhythmias and hypertensive heart disease. Coupled with a rising epidemic of rheumatic and structural heart disease affecting over 15- million individuals in these regions creates an urgent need that requires innovative and scalable methods to improve population- health, methods that reduce the cost of care, and simultaneously improves outcomes.
The World Health Organization's Millennium Developmental Goals has recently reported a rise in cellular phone technologies with 7-Billion devices in active circulation. Parallel developments with the globalization of Internet-based communication and the emergence of new smartphone-connected mobile health (mHealth) devices are providing new methods for patients to remotely monitor their chronic conditions and for providers to improve healthcare delivery. These technologies include smartphone 'apps', wearable and wireless devices such as the smartphone-ECG, sensor-based technologies, pocket-sized ultrasound and miniaturized lab-on-a-chip technologies. Several design features of mHealth are well suited for use in resource-limited areas and used as a practitioner-based diagnostic tool including portability, lower cost, and simple to use form factors. Although an attractive method for new technology utilization, the impact of mHealth used as a practitioner-based clinical-decision-support tool on subsequent management and outcomes has not been previously evaluated.
Several barriers to effective healthcare exist in resource-limited areas that requires multidisciplinary collaborations between the community, medical centers, health workers and patients. Developing new digital programs with healthcare innovations in these regions brings together a collaboration of industry, researchers, engineers and information technology partners. In the aggregate, a cumulative effort across several disciplines is necessary in order to assess the feasibility, utility, and impact of new devices in resource constrained areas. The investigators describe a multidisciplinary and global effort across institutions in India and the United States. The investigators received support from international medical societies and device manufacturers to advance our knowledge for technology utilization and to improve healthcare access and outcomes for patients in resource limited areas.
- Conditions
- Rheumatic Heart Disease, Heart Diseases
- Being tested
- mHealth, Standard-Care
- Keywords
- Mobile Health, Telemedicine, Pocket-Echocardiography
- Medical subject headings
- Rheumatic Heart Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthDevice
After randomization and at the time of the initial encounter, study subjects are assessed at the point-of-care with mHealth devices that measure symptoms, functional status, and for structural abnormalities. These devices include activity monitoring for an assessment of a 6-minute walk test, smartphone connected blood pressure, oxymetry and ECG for functional assessments, and structural assessments with handheld-echocardiography and point-of-care BNP. Treatment decisions for an intervention with percutaneous valvuloplasty or valve replacement were performed based on the aggregate of these mHealth findings. Confirmation of the severity of structural heart disease on transthoracic echocardiography was performed on all participants.
Standard-CareOther
After randomization and at the time of the initial encounter, study subjects randomized to standard-care underwent a physical examination, 12-lead ECG, radiographic and laboratory tests as warranted and clinically required. Treatment decisions for percutaneous valvuloplasty or valve replacement were based on the aggregate of the standard-care findings. Confirmation of the severity of structural heart disease on transthoracic echocardiography was performed on all participants.
| Study group | Role | What they receive |
|---|---|---|
| mHealth | Experimental | Each participant randomized to a mHealth assessment were evaluated with: (1) structural abnormalities with handheld-echocardiography (Vscan®, General Electric Healthcare); (2) vital signs with smartphone-connected oxymetry and blood pressure monitors (iHealthLabs®); (3) functional assessments on a 6-minute walk test with a trial-axial activity monitor (Ozeri®); (4) cardiac rhythm abnormalities with smartphone-connected- iECG (AliveCor®) and; (5)point-of-care testing with fingerstick B-type natriuretic peptide (Alere). All study participants then underwent a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease prior to percutaneous valvuloplasty or a surgical valve replacement. Receives: Device: mHealth |
| Standard-Care | Active comparator | Each participant randomized to a standard-assessment were evaluated with the resource available at the institution including a physical examination,12 lead-ECG, radiographic, laboratory testing as clinically required. All study participants underwent a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease prior to percutaneous valvuloplasty or a surgical valve replacement. Receives: Other: Standard-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to definitive treatment with Valvuloplasty or Valve Replacement
Measured: Upto 12 months after enrollment
Secondary outcomes (1)
Cardiovascular Hospitalization and/or Death
Secondary outcomes included the occurrence of a cardiovascular hospitalization and/or death over 12-months
Measured: Upto 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startAug 2014
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sri Sathya Sai Institute of Higher Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srikanth Sola, Sri Sathya Sai Institute of Higher Medical Sciences
- Investigators
- Srikanth Sola, MD, Principal investigator, Sri Sathya Sai Institute of Higher Medical SciencesSanjeev Bhavnani, MD, Study director, Scripps Clinic and Reseach InstitutePartho Sengupta, MD, Principal investigator, Icahn School of Medicine at Mt. Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881398
- Sponsor's protocol ID
- ASEF-VALUES
- Acronym
- ASEF-VALUES
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be made available to requesting investigators and 6 months after publication
Publications
Singh S, Bansal M, Maheshwari P, Adams D, Sengupta SP, Price R, Dantin L, Smith M, Kasliwal RR, Pellikka PA, Thomas JD, Narula J, Sengupta PP; ASE-REWARD Study Investigators. American Society of Echocardiography: Remote Echocardiography with Web-Based Assessments for Referrals at a Distance (ASE-REWARD) Study. J Am Soc Echocardiogr. 2013 Mar;26(3):221-33. doi: 10.1016/j.echo.2012.12.012.
PubMed 23439071Bansal M, Singh S, Maheshwari P, Adams D, McCulloch ML, Dada T, Sengupta SP, Kasliwal RR, Pellikka PA, Sengupta PP; VISION-in-Tele-Echo Study Investigators. Value of interactive scanning for improving the outcome of new-learners in transcontinental tele-echocardiography (VISION-in-Tele-Echo) study. J Am Soc Echocardiogr. 2015 Jan;28(1):75-87. doi: 10.1016/j.echo.2014.09.001. Epub 2014 Oct 8.
PubMed 25306222Bhavnani SP, Narula J, Sengupta PP. Mobile technology and the digitization of healthcare. Eur Heart J. 2016 May 7;37(18):1428-38. doi: 10.1093/eurheartj/ehv770. Epub 2016 Feb 11.
PubMed 26873093Bansal M, Sengupta PP. Setting global standards in adult echocardiography: Where are we? Indian Heart J. 2015 Jul-Aug;67(4):298-301. doi: 10.1016/j.ihj.2015.07.020. Epub 2015 Aug 21. No abstract available.
PubMed 26304560Drain PK, Hyle EP, Noubary F, Freedberg KA, Wilson D, Bishai WR, Rodriguez W, Bassett IV. Diagnostic point-of-care tests in resource-limited settings. Lancet Infect Dis. 2014 Mar;14(3):239-49. doi: 10.1016/S1473-3099(13)70250-0. Epub 2013 Dec 10.
PubMed 24332389Yusuf S, Rangarajan S, Teo K, Islam S, Li W, Liu L, Bo J, Lou Q, Lu F, Liu T, Yu L, Zhang S, Mony P, Swaminathan S, Mohan V, Gupta R, Kumar R, Vijayakumar K, Lear S, Anand S, Wielgosz A, Diaz R, Avezum A, Lopez-Jaramillo P, Lanas F, Yusoff K, Ismail N, Iqbal R, Rahman O, Rosengren A, Yusufali A, Kelishadi R, Kruger A, Puoane T, Szuba A, Chifamba J, Oguz A, McQueen M, McKee M, Dagenais G; PURE Investigators. Cardiovascular risk and events in 17 low-, middle-, and high-income countries. N Engl J Med. 2014 Aug 28;371(9):818-27. doi: 10.1056/NEJMoa1311890.
PubMed 25162888Marijon E, Ou P, Celermajer DS, Ferreira B, Mocumbi AO, Jani D, Paquet C, Jacob S, Sidi D, Jouven X. Prevalence of rheumatic heart disease detected by echocardiographic screening. N Engl J Med. 2007 Aug 2;357(5):470-6. doi: 10.1056/NEJMoa065085.
PubMed 17671255Engelman D, Kado JH, Remenyi B, Colquhoun SM, Carapetis JR, Donath S, Wilson NJ, Steer AC. Focused cardiac ultrasound screening for rheumatic heart disease by briefly trained health workers: a study of diagnostic accuracy. Lancet Glob Health. 2016 Jun;4(6):e386-94. doi: 10.1016/S2214-109X(16)30065-1.
PubMed 27198843Mirabel M, Bacquelin R, Tafflet M, Robillard C, Huon B, Corsenac P, de Fremicourt I, Narayanan K, Meunier JM, Noel B, Hagege AA, Rouchon B, Jouven X, Marijon E. Screening for rheumatic heart disease: evaluation of a focused cardiac ultrasound approach. Circ Cardiovasc Imaging. 2015 Jan;8(1):e002324. doi: 10.1161/CIRCIMAGING.114.002324.
PubMed 25567654Bhavnani SP, Sola S, Adams D, Venkateshvaran A, Dash PK, Sengupta PP; ASEF-VALUES Investigators. A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics. JACC Cardiovasc Imaging. 2018 Apr;11(4):546-557. doi: 10.1016/j.jcmg.2017.06.019. Epub 2017 Oct 5.
PubMed 28917688
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics
- ClinicalTrials.gov ID
- NCT02881398
- Acronym / sponsor ID
- ASEF-VALUES / ASEF-VALUES
- Conditions
- Rheumatic Heart Disease, Heart Diseases
- Keywords
- Mobile Health, Telemedicine, Pocket-Echocardiography
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Sri Sathya Sai Institute of Higher Medical SciencesUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Aug 2016 (estimated)
- 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 primary objective of this investigation was to assess the impact of new mobile health devices on health outcomes among patients with rheumatic and structural heart disease in a resource limited area. To achieve this aim the investigators utilized smartphone-connected devices such as the smartphone-ECG, activity monitors, connected blood pressure devices and pocket-sized and handheld ultrasound. The main question asked in this investigation is if mobile health assessments accelerates medical-decision-making and if it shortens the time to definitive therapy.
Detailed description
A recent paradigm-shift in the global burden of cardiovascular diseases has been observed with a decreasing prevalence in industrialized nations and an increasing prevalence in resource limited areas. This problem is further compounded with resource-limited areas receiving a disproportionately low allocation of global resources including diagnostic tests and trained healthcare professionals. Such cardiovascular conditions include heart failure, coronary artery disease, atrial arrhythmias and hypertensive heart disease. Coupled with a rising epidemic of rheumatic and structural heart disease affecting over 15- million individuals in these regions creates an urgent need that requires innovative and scalable methods to improve population- health, methods that reduce the cost of care, and simultaneously improves outcomes.
The World Health Organization's Millennium Developmental Goals has recently reported a rise in cellular phone technologies with 7-Billion devices in active circulation. Parallel developments with the globalization of Internet-based communication and the emergence of new smartphone-connected mobile health (mHealth) devices are providing new methods for patients to remotely monitor their chronic conditions and for providers to improve healthcare delivery. These technologies include smartphone 'apps', wearable and wireless devices such as the smartphone-ECG, sensor-based technologies, pocket-sized ultrasound and miniaturized lab-on-a-chip technologies. Several design features of mHealth are well suited for use in resource-limited areas and used as a practitioner-based diagnostic tool including portability, lower cost, and simple to use form factors. Although an attractive method for new technology utilization, the impact of mHealth used as a practitioner-based clinical-decision-support tool on subsequent management and outcomes has not been previously evaluated.
Several barriers to effective healthcare exist in resource-limited areas that requires multidisciplinary collaborations between the community, medical centers, health workers and patients. Developing new digital programs with healthcare innovations in these regions brings together a collaboration of industry, researchers, engineers and information technology partners. In the aggregate, a cumulative effort across several disciplines is necessary in order to assess the feasibility, utility, and impact of new devices in resource constrained areas. The investigators describe a multidisciplinary and global effort across institutions in India and the United States. The investigators received support from international medical societies and device manufacturers to advance our knowledge for technology utilization and to improve healthcare access and outcomes for patients in resource limited areas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth | Experimental | Device: mHealthEach participant randomized to a mHealth assessment were evaluated with: (1) structural abnormalities with handheld-echocardiography (Vscan®, General Electric Healthcare); (2) vital signs with smartphone-connected oxymetry and blood pressure monitors (iHealthLabs®); (3) functional assessments on a 6-minute walk test with a trial-axial activity monitor (Ozeri®); (4) cardiac rhythm abnormalities with smartphone-connected- iECG (AliveCor®) and; (5)point-of-care testing with fingerstick B-type natriuretic peptide (Alere). All study participants then underwent a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease prior to percutaneous valvuloplasty or a surgical valve replacement. |
| Standard-Care | Active comparator | Other: Standard-CareEach participant randomized to a standard-assessment were evaluated with the resource available at the institution including a physical examination,12 lead-ECG, radiographic, laboratory testing as clinically required. All study participants underwent a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease prior to percutaneous valvuloplasty or a surgical valve replacement. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic outpatients with a new or an established diagnosis of rheumatic and structural heart disease and included valvular disease, left/right ventricular failure, rheumatic valvular disease, congenital heart defects and included adult, pediatric, and pregnant patients. Patients with a prior valvuloplasty or valve replacement for structural heart disease were also included
Key exclusion criteria (1 listed)
- Exclusions included neonatal patients and those with an unstable hemodynamic status
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 |
|---|---|---|
| mHealthAfter randomization and at the time of the initial encounter, study subjects are assessed at the point-of-care with mHealth devices that measure symptoms, functional status, and for structural abnormalities. These devices include activity monitoring for an assessment of a 6-minute walk test, smartphone connected blood pressure, oxymetry and ECG for functional assessments, and structural assessments with handheld-echocardiography and point-of-care BNP. Treatment decisions for an intervention with percutaneous valvuloplasty or valve replacement were performed based on the aggregate of these mHealth findings. Confirmation of the severity of structural heart disease on transthoracic echocardiography was performed on all participants. | Device | mHealth |
| Standard-CareAfter randomization and at the time of the initial encounter, study subjects randomized to standard-care underwent a physical examination, 12-lead ECG, radiographic and laboratory tests as warranted and clinically required. Treatment decisions for percutaneous valvuloplasty or valve replacement were based on the aggregate of the standard-care findings. Confirmation of the severity of structural heart disease on transthoracic echocardiography was performed on all participants. | Other | Standard-Care |
Primary outcome
Time to definitive treatment with Valvuloplasty or Valve Replacement
Time frame: Upto 12 months after enrollment
1 secondary outcome
Cardiovascular Hospitalization and/or Death
Time frame: Upto 12 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Background: PubMed 23439071Singh S, Bansal M, Maheshwari P, Adams D, Sengupta SP, Price R, Dantin L, Smith M, Kasliwal RR, Pellikka PA, Thomas JD, Narula J, Sengupta PP; ASE-REWARD Study Investigators. American Society of Echocardiography: Remote Echocardiography with Web-Based Assessments for Referrals at a Distance (ASE-REWARD) Study. J Am Soc Echocardiogr. 2013 Mar;26(3):221-33. doi: 10.1016/j.echo.2012.12.012.
- Background: PubMed 25306222Bansal M, Singh S, Maheshwari P, Adams D, McCulloch ML, Dada T, Sengupta SP, Kasliwal RR, Pellikka PA, Sengupta PP; VISION-in-Tele-Echo Study Investigators. Value of interactive scanning for improving the outcome of new-learners in transcontinental tele-echocardiography (VISION-in-Tele-Echo) study. J Am Soc Echocardiogr. 2015 Jan;28(1):75-87. doi: 10.1016/j.echo.2014.09.001. Epub 2014 Oct 8.
- Background: PubMed 26873093Bhavnani SP, Narula J, Sengupta PP. Mobile technology and the digitization of healthcare. Eur Heart J. 2016 May 7;37(18):1428-38. doi: 10.1093/eurheartj/ehv770. Epub 2016 Feb 11.
- Background: PubMed 26304560Bansal M, Sengupta PP. Setting global standards in adult echocardiography: Where are we? Indian Heart J. 2015 Jul-Aug;67(4):298-301. doi: 10.1016/j.ihj.2015.07.020. Epub 2015 Aug 21. No abstract available.
- Background: PubMed 24332389Drain PK, Hyle EP, Noubary F, Freedberg KA, Wilson D, Bishai WR, Rodriguez W, Bassett IV. Diagnostic point-of-care tests in resource-limited settings. Lancet Infect Dis. 2014 Mar;14(3):239-49. doi: 10.1016/S1473-3099(13)70250-0. Epub 2013 Dec 10.
- Background: PubMed 25162888Yusuf S, Rangarajan S, Teo K, Islam S, Li W, Liu L, Bo J, Lou Q, Lu F, Liu T, Yu L, Zhang S, Mony P, Swaminathan S, Mohan V, Gupta R, Kumar R, Vijayakumar K, Lear S, Anand S, Wielgosz A, Diaz R, Avezum A, Lopez-Jaramillo P, Lanas F, Yusoff K, Ismail N, Iqbal R, Rahman O, Rosengren A, Yusufali A, Kelishadi R, Kruger A, Puoane T, Szuba A, Chifamba J, Oguz A, McQueen M, McKee M, Dagenais G; PURE Investigators. Cardiovascular risk and events in 17 low-, middle-, and high-income countries. N Engl J Med. 2014 Aug 28;371(9):818-27. doi: 10.1056/NEJMoa1311890.
- Background: PubMed 17671255Marijon E, Ou P, Celermajer DS, Ferreira B, Mocumbi AO, Jani D, Paquet C, Jacob S, Sidi D, Jouven X. Prevalence of rheumatic heart disease detected by echocardiographic screening. N Engl J Med. 2007 Aug 2;357(5):470-6. doi: 10.1056/NEJMoa065085.
- Background: PubMed 27198843Engelman D, Kado JH, Remenyi B, Colquhoun SM, Carapetis JR, Donath S, Wilson NJ, Steer AC. Focused cardiac ultrasound screening for rheumatic heart disease by briefly trained health workers: a study of diagnostic accuracy. Lancet Glob Health. 2016 Jun;4(6):e386-94. doi: 10.1016/S2214-109X(16)30065-1.
- Background: PubMed 25567654Mirabel M, Bacquelin R, Tafflet M, Robillard C, Huon B, Corsenac P, de Fremicourt I, Narayanan K, Meunier JM, Noel B, Hagege AA, Rouchon B, Jouven X, Marijon E. Screening for rheumatic heart disease: evaluation of a focused cardiac ultrasound approach. Circ Cardiovasc Imaging. 2015 Jan;8(1):e002324. doi: 10.1161/CIRCIMAGING.114.002324.
- Derived from this study: PubMed 28917688Bhavnani SP, Sola S, Adams D, Venkateshvaran A, Dash PK, Sengupta PP; ASEF-VALUES Investigators. A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics. JACC Cardiovasc Imaging. 2018 Apr;11(4):546-557. doi: 10.1016/j.jcmg.2017.06.019. Epub 2017 Oct 5.
- Individual participant dataSharing planned: Yes. Data will be made available to requesting investigators and 6 months after publication
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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.
Srikanth Sola, MD principal investigator
Sri Sathya Sai Institute of Higher Medical Sciences
Sanjeev Bhavnani, MD study director
Scripps Clinic and Reseach Institute
Partho Sengupta, MD principal investigator
Icahn School of Medicine at Mt. Sinai
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing mHealth and Standard-Care in people with Rheumatic Heart Disease and Heart Diseases, run by Sri Sathya Sai Institute of Higher Medical Sciences.
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: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to definitive treatment with Valvuloplasty or Valve Replacement (time frame: Upto 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881398, which also lists 10 linked publications.
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 29 Aug 2016.