Significance of Impedance Cardiography and Early Repolarization Pattern in ECG in Congestive Heart Failure

NCT05480345 | Completed

• 1 other identifier: HF-ER-001
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

Congestive heart failure (CHF) is a disorder of the heart when structural or functional heart disease impairs the heart's ability to work properly. In developed countries, the prevalence of CHF in the general population is around 1-2% (depending on the definition used) and the prevalence of CHF in people aged 70 years and older is ≥ 10%. The cumulative 5-year mortality of patients with CHF is about 50%. According to different studies, the prevalence of the early repolarization pattern (ERP) in the 12-lead electrocardiogram (ECG) in the general population is 2-31%. Although ERP in ECG have been considered as benign finding for many years, an increasing number of studies have been conducted in recent years to demonstrate an association of ERP in ECG with sudden cardiac death, mainly through ventricular arrhythmias in previously healthy individuals or those with structural cardiac pathology. New studies are also being performed to support the association of ERP with the progression of CHF. Although the prevalence of ERP in the general population is not very high, the knowledge that ERP lead to a higher risk of sudden cardiac death and development of CHF lets physicians tailor patient care and follow-up, and treatment at a very low cost because ECG is a cheap, simple, and widely available diagnostic test. Impedance cardiography (ICG) is another safe, non-invasive, cheap, routine diagnostic method based on the detection of changes in thoracic bioimpedance during heartbeat. The aim of the present study is to evaluate the diagnostic and prognostic significance of ICG and ERP in congestive heart failure patients and to compare it with other non-invasive CHF diagnostic methods. The investigators hypothesize that ERP and changes in ICG readings may be used as a cheap, safe, non-invasive and widely available diagnostic and prognostic methods in patients with congestive heart failure witch help physicians tailor their patient follow-up and treatment accordingly. The participants of the study are those who are hospitalized due to the flare-up of congestive heart failure. All of the participants will undergo routine tests. They will also undergo an ICG witch is not a routine test in the research center.

Conditions

Congestive Heart Failure; Chronic Heart Failure; Right Ventricular Failure; Heart Failure

Keywords

Cardiography, impedance; Early repolarization pattern; Electrocardiography; Prognosis

Outcome Measures

Primary Outcomes (3)

• In-hospital stay duration

  In-hospital stay duration measured in days: early patient outcomes (discharge time from the hospital or time of any cause death)

  Day of discharge from the hospital or day of death from any cause, whichever came first, assessed throughout the whole hospital admission stay

• Rehospitalizations

  Latter patient outcomes: number of rehospitalizations due to congestive heart failure

  Follow-up up to 12 months

• Time of death

  Latter patient outcomes: time to death (measured in days) due to congestive heart failure. Data were collected from Lithuanian medical record database (Electronic information system's of health services and cooperation infrastructure)

  From date of hospitalization until the date of death of congestive heart failure, follow-up through study completion, an average of 1.5 year

Secondary Outcomes (8)

• Early patient outcome 1a

  On the day of patient's discharge from the hospital

• Early patient outcome 1b

  On the day of patient's discharge from the hospital

• Early patient outcome 2a

  On the day of patient's discharge from the hospital

• Early patient outcome 2b

  On the day of patient's discharge from the hospital

• Early patient outcome 3

  On the day of patient's discharge from the hospital

Study Arms (1)

Impedance cardiography

EXPERIMENTAL

Impedance cardiography parameters recorded with ICG monitor (niccomoTM; Medis, Ilmenau, Germany)

Diagnostic Test: Impedance cardiography

Interventions

Impedance cardiography DIAGNOSTIC_TEST

Transthoracic impedance cardiography recorded with ICG monitor (niccomoTM; Medis, Ilmenau, Germany): electrodes attached to both sides of the patient's neck (4 electrodes in total) and along the midaxillary line of the left and right sides of the chest (4 electrodes in total), employing the xyphoid process as a reference line.

Also known as: ICG monitor (niccomoTM; Medis, Ilmenau, Germany)

Impedance cardiography

Eligibility Criteria

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

You may qualify if:

• patients hospitalized due to a flare-up of congestive heart failure;
• early repolarization pattern in a 12-lead ECG;
• free from mental disorders;
• participants signed the informed consent form.

You may not qualify if:

• septic shock;
• high grade aortic valve regurgitation;
• high grade aortic valve stenosis;
• ventricular septal defect;
• prosthetic aortic valve;
• uncontrolled hypertension (mean arterial pressure \>130 mmHg);
• heart rate \> 200 bpm;
• height \<120 cm or \>230 cm;
• weight \<30 kg or \>155 kg;
• intra-aortic balloon counterpulsation;
• pacemaker with a minute ventilation sensor;
• restless patient;
• patient refuses to participate.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences Kaunas Hospital

Kaunas, LT-47144, Lithuania

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiography, Impedance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Plethysmography, Impedance; Plethysmography

Study Officials

• Andrius Ališauskas, MD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine, Assistant lecturer

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: July 29, 2022
• Study Start: December 20, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available from 2022-08-01 through 2027-08-01.
• Access Criteria: Data will be shared with other principal investigators in the field of congestive heart failure research. Requests should be submitted to study's principal investigator MD Andrius Ališauskas at: andrius.alisauskas@lsmu.lt

Locations

LI (1)