Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices
NCT ID: NCT01430936
Last Updated: 2012-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
51 participants
OBSERVATIONAL
2011-01-31
2012-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AT&T
UNKNOWN
BMS Hospital Trust
OTHER
University of California
OTHER
Zephyr Technology
OTHER
Aventyn, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Satish C Govind, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vivus-BMJ Heart Centre
Marcus Stahlberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Bagirath K, MD
Role: STUDY_DIRECTOR
Narayana Hruduyalaya Hospital
Justine S Lachmann, MD
Role: STUDY_DIRECTOR
Winthrop University Hospital
Nicole Orr, MD
Role: STUDY_DIRECTOR
Saint Francis Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Winthrop University Hospital
Mineola, New York, United States
Saint Francis Hospital
Roslyn, New York, United States
Narayana Hrudayalaya Hospital
Bangalore, Karnataka, India
Vivus-BMJ Heart Centre
Bangalore, Karnataka, India
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AVN-111
Identifier Type: -
Identifier Source: org_study_id