Status:
COMPLETED
Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices
Lead Sponsor:
Aventyn, Inc.
Collaborating Sponsors:
AT&T
BMS Hospital Trust
Conditions:
Cardiac Decompensation
Eligibility:
All Genders
18+ years
Brief Summary
This is planned as a feasibility study. The objective is to evaluate a specially designed patient adherence and monitoring software on standard mobile devices in remote monitoring of heart failure pat...
Detailed Description
Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients ...
Eligibility Criteria
Inclusion
- Subjects of either gender above the age of 18 years
- The subject is able and willing to provide written informed consent prior to enrollment in the study
- New York Heart Association (NYHA) classification class of II-IV
- Left ventricular ejection fraction (LVEF) less than 40%
- One or more prior hospitalization within the last six months for symptoms, management of heart failure.
Exclusion
- Disability of fingers or upper limbs (unable to use devices)
- Visually impaired
- Those unable to read and write
- Hearing dysfunction
- Significant cognitive disabilities, mental illness
- Those who are unable to handle electronic devices
- Those residing in places outside the local mobile phone coverage
- Chronic renal failure on renal replacement therapy
- Patients who may not come for follow up or likely to drop out of the study
- Those awaiting cardiac transplantation
- Any illness which may preclude regular follow up
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01430936
Start Date
January 1 2011
End Date
April 1 2012
Last Update
July 10 2012
Active Locations (5)
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1
Winthrop University Hospital
Mineola, New York, United States, 11501
2
Saint Francis Hospital
Roslyn, New York, United States, 11576
3
Narayana Hrudayalaya Hospital
Bangalore, Karnataka, India, 560 099
4
Vivus-BMJ Heart Centre
Bangalore, Karnataka, India, 560080