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.
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
- Conditions the study is for
- Congestive Heart Failure, Chronic Heart Failure, Right Ventricular Failure
- 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
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 group | Role | What they receive |
|---|---|---|
| Impedance cardiography | Experimental | Impedance 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.
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
Rehospitalizations
Latter patient outcomes: number of rehospitalizations due to congestive heart failure
Measured: 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)
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)
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
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
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
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
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
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
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
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.
- First posted29 Jul 2022
- Study start20 Dec 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrius Ališauskas, Lithuanian University of Health Sciences
- Investigators
- Andrius Ališauskas, MD, Principal investigator, Lithuanian University of Health Sciences
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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Impedance Cardiography and Early Repolarization Pattern in Electrocardiogram in Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT05480345
- Acronym / sponsor ID
- SICERE-CHF / HF-ER-001
- Keywords
- Cardiography, impedance, Early repolarization pattern, Electrocardiography, Prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impedance cardiography | Experimental | Diagnostic Test: Impedance cardiographyImpedance cardiography parameters recorded with ICG monitor (niccomoTM; Medis, Ilmenau, Germany) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- septic shock;
- high grade aortic valve regurgitation;
- high grade aortic valve stenosis;
- ventricular septal defect;
- prosthetic aortic valve;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impedance cardiographyAlso: 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. | Diagnostic test | Impedance cardiography |
Primary outcome
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
In-hospital stay duration measured in days: early patient outcomes (discharge time from the hospital or time of any cause death)
Rehospitalizations
Time frame: Follow-up up to 12 months
Latter patient outcomes: number of rehospitalizations due to congestive heart failure
Time of death
Time frame: From date of hospitalization until the date of death of congestive heart failure, follow-up through study completion, an average of 1.5 year
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)
8 secondary outcomes
Early patient outcome 1a
Time frame: On the day of patient's discharge from the hospital
Early patient outcome 1b
Time frame: On the day of patient's discharge from the hospital
Early patient outcome 2a
Time frame: On the day of patient's discharge from the hospital
Early patient outcome 2b
Time frame: On the day of patient's discharge from the hospital
Early patient outcome 3
Time frame: On the day of patient's discharge from the hospital
Early patient outcome 4a
Time frame: On the day of patient's discharge from the hospital
Early patient outcome 4b
Time frame: On the day of patient's discharge from the hospital
Serum BNP level
Time frame: On the day of patient's discharge from the hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrius Ališauskas, MD principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
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.