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Congestive Heart FailureSICERE-CHFNCT05480345

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

A study testing Impedance cardiography in people with Congestive Heart Failure and Chronic Heart Failure, run by Lithuanian University of Health Sciences at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Impedance cardiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
1 siteLithuania
Study dates
20 Dec 2019to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site
  • Lithuanian University of Health Sciences Kaunas Hospital

    Kaunas, LT-47144

Other trials in Lithuania

About this study

Official title: Significance of Impedance Cardiography and Early Repolarization Pattern in Electrocardiogram in Congestive Heart Failure

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.

Read more

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.

Read the detailed description

Congestive heart failure (CHF) is a disorder of the heart when structural or functional heart disease impairs the heart's ability to fill with blood or pump it out 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%. In 2018 in Lithuania CHF accounted for 5.64 hospitalizations per 1000 people in general population. Mortality rate was 155.17 per 1,000 patients and the average length of in hospital stay was 26.64 days.

In order to improve the diagnosis, treatment and financial costs in patients with CHF it is important to search for diagnostic methods that are cheap, effective, preferably non-invasive, as well as those that have reliable prognostic significance for patients with CHF.

According to different studies, the prevalence of early repolarization pattern (ERP) in the 12-lead electrocardiogram (ECG) in the general population is 2-31%. This may be due to different ERP definitions used by different authors. 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 in ECG with the progression of CHF. ERP, which has been first described in 1936 by Shipley and Hallaran, is generally defined as J-point (J-p) elevation with QRS notching or slurring in the terminal part of the QRS complex in at least two adjacent inferior (II, III, and aVF) and / or lateral leads (I, aVL, and V4-V6) detected by the standard 12-lead electrocardiogram. The amplitude of the J point must be at least 1 mm (0.1 mV) and the J-p must appear as an additional positive wave in the S wave (QRS notching) or the J-p may appear as a faint transition of the high R wave to the ST segment without Jp-QRS slurring, QRS duration should be <120 ms and anterior precordial leads (V1-3) are not included in the description of ERP because such changes in these leads may be due to Brugada syndrome or right ventricular dysplasia. Although the prevalence of ERP in ECG in the general population is not very high, the knowledge that ERP in ECG 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 an 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 heart cycle. A lot of research has been carried out in recent years which examines the possibilities of ICG in CHF patients in various aspects: diagnostics, treatment, prognosis. A good correlation between ICG, cardiac ultrasound and invasive diagnostic methods was observed in most studies.

Evaluating CHF patients, it is important to evaluate thoracic fluid content (TFC) that can be used to diagnose a flare-up of CHF, its degree, to evaluate the effectiveness of treatment, as well as the prognosis of patients. ICG evaluate the TFC and its index. In clinical practice, it is important to predict the flare-ups of CHF, to predict the outcome of CHF patients, and to provide appropriate treatment to patients timely. Various prognostic indicators are studied: ICG parameters (TFC, TFC index, cardiac output (CO), CO index, systolic time ratio, etc.), brain natriuretic peptide (BNP), New York Heart Association (NYHA) classes. The current data are quite controversial, with most studies reporting positive ICG data as a predictor of CHF.

The aim of the present study is to evaluate the diagnostic and prognostic significance of ICG and ERP in ECG in CHF patients and to compare it with other non-invasive CHF diagnostic methods. The investigators hypothesize that ERP in ECG and changes in ICG readings may be used as a cheap, safe, non-invasive and widely available diagnostic and prognostic methods in patients with CHF 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 CHF. All of the participants will undergo routine tests. They will also undergo an ICG witch is not a routine test in the research center.

Being tested
Impedance cardiography
Keywords
Cardiography, impedance, Early repolarization pattern, Electrocardiography, Prognosis
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Impedance cardiographyDiagnostic test

    Also called ICG monitor (niccomoTM; Medis, Ilmenau, Germany)

    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.

Study groups in NCT05480345
Study groupRoleWhat they receive
Impedance cardiographyExperimentalImpedance cardiography parameters recorded with ICG monitor (niccomoTM; Medis, Ilmenau, Germany)
Receives: Diagnostic Test: Impedance cardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. Rehospitalizations

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

    Measured: Follow-up up to 12 months

  3. 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)

    Measured: 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)
  1. Early patient outcome 1a

    Early patient outcomes: repeated evaluation of TFC on the day of discharge from the hospital

    Measured: On the day of patient's discharge from the hospital

  2. Early patient outcome 1b

    Early patient outcomes: repeated evaluation TFC index on the day of discharge from the hospital

    Measured: On the day of patient's discharge from the hospital

  3. Early patient outcome 2a

    Early patient outcomes: repeated evaluation of cardiac output (CO) on the day of discharge from the hospital

    Measured: On the day of patient's discharge from the hospital

  4. Early patient outcome 2b

    Early patient outcomes: repeated evaluation of CO index on the day of discharge from the hospital

    Measured: On the day of patient's discharge from the hospital

  5. Early patient outcome 3

    Early patient outcomes: repeated evaluation of systolic time ratio (STR) on the day of discharge from the hospital

    Measured: On the day of patient's discharge from the hospital

  6. Early patient outcome 4a

    Early patient outcomes: repeated evaluation of left cardiac work (LCW) on the day of discharge from the hospital

    Measured: On the day of patient's discharge from the hospital

  7. Early patient outcome 4b

    Early patient outcomes: repeated evaluation of left cardiac work index (LCWI) on the day of discharge from the hospital

    Measured: On the day of patient's discharge from the hospital

  8. Serum BNP level

    Serum BNP level on the day of discharge from the hospital

    Measured: On the day of patient's discharge from the hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start20 Dec 2019
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05480345
Sponsor's protocol ID
HF-ER-001
Acronym
SICERE-CHF
Status last verified
Jul 2022
First submitted
6 Apr 2022
Last updated
29 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data that underlie results in a publication.

Questions about this trial

What is this clinical trial studying?

A study testing Impedance cardiography in people with Congestive Heart Failure and Chronic Heart Failure, run by Lithuanian University of Health Sciences at 1 site in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital stay duration (time frame: Day of discharge from the hospital or day of death from any cause, whichever came first, assessed throughout the whole hospital admission stay). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.

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