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Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01377350
First received: May 18, 2011
Last updated: June 20, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to explore the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.


Condition Intervention
Heart Failure
Device: "Pneumedicare"s monitoring system.
Device: "Pneumedicare"s monitoring system

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • earliest non-invasive signs for lung congestion and deterioration in the heart failure [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Exploring the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: "Pneumedicare"s monitoring system
Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients
Device: "Pneumedicare"s monitoring system.
50 patients hospitalized due to the decompensated HF are considered for entry. 3 patches will be attached to the patients' thorax that include motion sensors. The system will be attached to the patients at the start of treatment. Patient's signals will be recorded during the entire treatment in the hospital, to the point that there is an improvement in their health condition.
Other Name: "Pneumedicare"s monitoring system for heart failure patients
Device: "Pneumedicare"s monitoring system
Non invasive clinical follow-up of patients with HF deterioration and improvement, by a device-based algorithm. The system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation.
Other Name: "Pneumedicare"s monitoring system for heart failure patients

Detailed Description:

Pulmonary veins congestion and fine changes in alveolar transudative effusion accumulation affect lung mechanics (compliance) and the respiratory effort. Moreover, the associated state of oxygen de-saturation is compensated by an increase in the respiratory effort. These changes in the respiratory effort are reflected in chest wall dynamics and may provide the earliest non-invasive sign for lung congestion and deterioration in the heart failure.

The research system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. The signals are acquired by a miniaturized device that amplifies and samples the signals, stores and analyzes the data and displays the trends on the screen.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute decompensated HF
  • Decompensated chronic HF in patients with NYHA class III-IV symptoms
  • Age over 20 years
  • Ejection fraction reduced below 35% OR doppler evidence of impaired left ventricular diastolic filling

Exclusion Criteria:

  • Inability or unwillingness to follow the study protocol
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377350

Contacts
Contact: Shmuel rispler, MD PhD 972-4-8542180 s_rispler@rambam.health.gov.il
Contact: Amir Landesberg, MD PhD 972-505482249 Amir@bm.technion.ac.il

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel, 31096
Contact: Shmuel Rispler, MD PhD    972-4-8542180    s_rispler@rambam.health.gov.il   
Contact: Amir Landesberg, MD PhD    972-505482249    Amir@bm.technion.ac.il   
Principal Investigator: Shmuel Rispler, MD PhD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Shmuel Rispler, MD PhD Rambam Medical Center Haifa Israel
  More Information

No publications provided

Responsible Party: Shmuel Rispler, Rambam Health Care Campus, P.O.B. 9602, Haifa 31096, Israel
ClinicalTrials.gov Identifier: NCT01377350     History of Changes
Other Study ID Numbers: 0550-10ctil, ministry of health Israel
Study First Received: May 18, 2011
Last Updated: June 20, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Heart failure
monitoring

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014