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Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices (REMOTE-HF-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01430936
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : July 10, 2012
BMS Hospital Trust
University of California
Zephyr Technology
Information provided by (Responsible Party):
Aventyn, Inc.

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 patients.

Condition or disease
Cardiac Decompensation

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 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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Study Type : Observational
Actual Enrollment : 51 participants
Time Perspective: Prospective
Official Title: Remote Monitoring of Heart Failure Patients (REMOTE-HF-1) Study - to Assess Utility of a Mobile Device for Improved Management of At-risk Patients
Study Start Date : January 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. Measuring resiliency and reliability of mobile technology for transmitting and retrieval of daily patient vital signs and symptoms as per discharge guideline [ Time Frame: 3 months ]
    Investigators instruct patients to send the clinical data (all measured parameters plus symptoms experienced over the previous 24 hours) via the mobile device every day to the local investigator. The monitoring site maintains a log of all data transmitted and received from the patient and to the patient and, any device malfunction/technical problems, unscheduled SMS/Text messages from patient and to the patient is also to be documented in the case report form for the entire duration of study.

Secondary Outcome Measures :
  1. Measuring quality of life score of heart failure patients on a qualitative scale [ Time Frame: 3 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary care population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01430936

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United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Saint Francis Hospital
Roslyn, New York, United States, 11576
Narayana Hrudayalaya Hospital
Bangalore, Karnataka, India, 560 099
Vivus-BMJ Heart Centre
Bangalore, Karnataka, India, 560080
Karolinska University Hospital
Stockholm, Sweden, 171 77
Sponsors and Collaborators
Aventyn, Inc.
BMS Hospital Trust
University of California
Zephyr Technology
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Principal Investigator: Satish C Govind, MD, PhD Vivus-BMJ Heart Centre
Principal Investigator: Marcus Stahlberg, MD, PhD Karolinska University Hospital
Study Director: Bagirath K, MD Narayana Hruduyalaya Hospital
Study Director: Justine S Lachmann, MD Winthrop University Hospital
Study Director: Nicole Orr, MD Saint Francis Memorial Hospital
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Responsible Party: Aventyn, Inc. Identifier: NCT01430936    
Other Study ID Numbers: AVN-111
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012
Keywords provided by Aventyn, Inc.:
Vascular Diseases
Chronic Kidney Disease
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases