Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

NCT ID: NCT01377350

Last Updated: 2011-06-21

Study Results

Results pending

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.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

"Pneumedicare"s monitoring system

Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients

Group Type EXPERIMENTAL

"Pneumedicare"s monitoring system.

Intervention Type DEVICE

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.

"Pneumedicare"s monitoring system

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

"Pneumedicare"s monitoring system for heart failure patients "Pneumedicare"s monitoring system for heart failure patients

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rambam Health Care Campus, P.O.B. 9602, Haifa 31096, Israel

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shmuel Rispler, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Rambam Medical Center Haifa Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shmuel rispler, MD PhD

Role: CONTACT

972-4-8542180

Amir Landesberg, MD PhD

Role: CONTACT

972-505482249

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shmuel Rispler, MD PhD

Role: primary

972-4-8542180

Amir Landesberg, MD PhD

Role: backup

972-505482249

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ministry of health Israel

Identifier Type: OTHER

Identifier Source: secondary_id

0550-10ctil

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.