MedTrace Logo

Optimization of the Treatment of Acute HF by a Non Invasive Cardiac System-a Randomized Control Trial

NCT02126254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-07-07

No results posted yet for this study

Summary

The aim of this trial is to compare the efficacy of NICaS-directed treatment strategy to the common treatment strategy (based on clinical judgment) on morbidity and mortality in patients with decompensated congestive heart failure, and accordingly to assess whether the NICaS system can optimize and individualize the treatment of decompensated heart failure patients. A prospective randomized controlled trial in which Known HF patients, with reduced EF \<40%, admitted due to decompensated HF, will be randomly assigned, in a 1:1: ratio, to either: 1) Control group that will be treated in the cardiology and internal medicine departments according to the guidelines for the management of Heart Failure. 2) Hemodynamic group patients will be examined in the cardiology and internal medicine departments and treated according to the NICaS system in addition to current guidelines. Patients in this group will be tested within 12 hours from hospitalization and thereafter on an everyday basis until discharge. For all patients randomized, therapy will be tailored to the ultimate goal of discharge on an oral medical regimen to provide better relief of CHF symptoms, to reduce filling pressures and to maintain adequate perfusion. These goals are the same for both groups, but in the control group therapy will be adjusted according to clinical assessment alone, while in the NICaS-directed group, actual measurement of hemodynamics will be used to supplement clinical assessment.

Conditions

Interventions

DEVICE

Hemodynamic group

NICAS guided treatment

Sponsors & Collaborators

  • Tel Aviv Medical Center

    collaborator OTHER

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Yaron Arbel, MD · Tel Aviv Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-03-31
Completion
2015-05-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126254 on ClinicalTrials.gov