Measurements of Doppler Signals Noninvasively From the Lung in Congestive Heart Failure

NCT01940328 | Completed

• 1 other identifier: DOP13
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the lung Doppler signals in left HF patients with and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF patients respectively), in comparison to a control group of subjects without CHF (non-CHF controls), in order to determine the diagnostic value of this non-invasive method in CHF. If this method will prove to be of diagnostic value, it could potentially be used to diagnose and monitor CHF patients in both inpatient and outpatient settings.

Conditions

Pulmonary Edema

Keywords

Ultrasound Doppler; Congestive heart failure; Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

• Diagnose specific pattern of LDS in patients by features as velocity, power etc in comparison to controls

  1.5y to collect all data and obtain a diagnostic pattern

Study Arms (3)

Decompensated CHF

patients with acute pulmonary congestion or pulmonary edema

Device: Transchoracic ultrasound Doppler

Compensated CHF

patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion

Device: Transchoracic ultrasound Doppler

Non CHF patients

patients without CHF and without uncontrolled hypertension.

Device: Transchoracic ultrasound Doppler

Interventions

Transchoracic ultrasound Doppler DEVICE

Compensated CHF; Decompensated CHF; Non CHF patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 150 mpatients will be recruited during 18 months: 50 Acute decompensated left heart failure;50 compensated left heart failure;50 non-CHF controls.

You may qualify if:

• Age over 18 years
• Belongs to one of the following categories:
• A. Acute decompensated left HF: patients with acute pulmonary congestion or pulmonary edema diagnosed on the basis of all of the following criteria:
• Dyspnea at rest or with minimal activity
• Rales on auscultation
• Evidence of pulmonary congestion or edema on chest X-ray.
• BNP level \>400 pg/ml
• B. Compensated left HF: patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion. The following 3 criteria must be met:
• No dyspnea at rest
• No rales on auscultation
• BNP levels \< 100 pg/ml
• C. Non-CHF controls: patients without CHF and without uncontrolled hypertension.
• Signed Informed Consent

You may not qualify if:

• \- Decompensated left HF subgroup \& Non CHF controls
• Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS)
• Interstitial lung disease
• Severe kyphosis, scoliosis or chest wall deformity
• Pregnant women
• Compensated left HF subgroup
• Chronic obstructive pulmonary disease (COPD)
• Asthma
• Interstitial lung disease
• Any other obstructive or restrictive lung diseases
• Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS)
• Current or past pulmonary embolism
• Large right sided pleural effusion
• Severe kyphosis, scoliosis or chest wall deformity
• Pregnant woman

Sponsors & Collaborators

• Echosense Ltd.: lead

Study Sites (1)

EMD Rambam Hospital

Haifa, Israel

Location

MeSH Terms

Conditions

Pulmonary Edema; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Shmuel Rispler, MD, PhD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 8, 2017

Record last verified: 2013-08

Locations

IL (1)