Heart Failure Clinical Trial

Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices

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 patients.

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Full 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 is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system.

Heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, medications and other important parameters and communicate this data to care providers using wireless technology. This data should be made available to medical personnel regularly and on a periodic basis. In this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Heart Failure

Estimated Enrollment:

51

Study ID:

NCT01430936

Recruitment Status:

Completed

Sponsor:

Aventyn, Inc.

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There are 5 Locations for this study

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Winthrop University Hospital
Mineola New York, 11501, United States
Saint Francis Hospital
Roslyn New York, 11576, United States
Narayana Hrudayalaya Hospital
Bangalore Karnataka, 560 0, India
Vivus-BMJ Heart Centre
Bangalore Karnataka, 56008, India
Karolinska University Hospital
Stockholm , 171 7, Sweden

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

51

Study ID:

NCT01430936

Recruitment Status:

Completed

Sponsor:


Aventyn, Inc.

How clear is this clinincal trial information?

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