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

NCT02126254 | Completed

• 1 other identifier: TASMC-14-YA-055-CTIL
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure; Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Renal function deterioration during hospitalization

  Renal function deterioration during hospitalization - worsening renal function (defined as an increase in the serum creatinine level of more than 0.3 mg per deciliter) at any time from randomization to dischage.

  6 months

Secondary Outcomes (12)

• 30 days rehospitalization due to decompensated heart failure

  30 days

• Length of hospitalization

  3 months

• All cause mortality at 30 days

  30 days

• All cause mortality at 3 months

  3 months

• All cause rehospitalization at 3 months

  3 months

Study Arms (2)

Control group

NO INTERVENTION

Control group will be treated in the cardiology and internal medicine departments according to the guidelines for the management of Heart Failure

Hemodynamic group

ACTIVE COMPARATOR

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

Device: Hemodynamic group

Interventions

Hemodynamic group DEVICE

NICAS guided treatment

Hemodynamic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• HF admitted patient from cardiology and internal medicine departments in our institution.
• Reduced EF ≤ 40%.
• Elevated filling pressures, indicated by one symptom AND one physical sign: Symptoms : Dyspnea at rest, in the supine position, OR immediately upon routine activity, abdominal discomfort, severe anorexia, or nausea without apparent cause other than hepatosplanchnic congestion Signs: Jugular venous pressure elevation \>10 cm above the right atrium, hepatomegaly, ascites, or edema in the absence of other obvious causes, rales greater than 1/3 lung fields, oxygen saturation \< 90 % in room air, pulmonary venous congestion determined from chest x-ray films

You may not qualify if:

• Severe aortic valve regurgitation and/or aortic stenosis.
• Aortic aneurysm.
• Heart rate above 130 beats/min.
• Intra- and extra-cardiac shunts.
• Severe peripheral vascular disease.
• Severe pitting edema.
• Sepsis.
• Use of hemodialysis.
• Patients under 18 years of age.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Tel Aviv Medical Center: collaborator

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Yaron Arbel, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tel-Aviv Medical Center

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

IL (1)