Hypertrophic CardiomyopathyNCT04402268
Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Cardioverter-defibrillator
- Type of treatment
- Medical device
- How many people
- 252 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2014to 28 Feb 2019
- Phase
- Observational
- 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
Study population: The study group consisted of 252 patients with hypertrophic cardiomyopathy aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6% were men.
Who may be able to join
- Hypertrophic cardiomyopathy,
- Minimum 18 years,
- Questionnaire,
- Assessment of HCM SCD-Risk Calculator at the beginning of the observation,
- Regular visits in Cardiology Outpatient Clinic,
- Agreement to participate in the study
Who cannot join
- Poorly controlled hypertension (systolic pressure on the next two visits in the Cardiology Outpatient Clinic >180 mmHg),
- Haemodynamically significant valvular heart disease or valve replacement condition,
- Past myocardial infarction (haemodynamically significant changes found in coronarography),
- Heart transplant,
- Insufficient amount of data from the subject and additional tests allowing for further analysis,
- Lack of consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan Univeristy of Medical Sciences
Poznan, Wielkopolska, 61-848
About this study
Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. The disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (SCD) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign course. Therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (ICD) implantation.
Read the detailed description
Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. The disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (SCD) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign course. Therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (ICD) implantation.
This study assesses the accuracy of the HCM SCD-Risk Calculator, recommended by European Society of Cardiology guidelines, in patients treated in the Ist Department of Cardiology of Poznan University of Medical Sciences from 2005 to 2018.
The study group consisted of 252 patients aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6% were men. The protocol consisted of medical history collection (including a questionnaire), physical examination and additional tests such as echocardiography with the assessment of global longitudinal strain and average strain, cardiac magnetic resonance, ambulatory ECG monitoring, control of implantable devices and exercise testing.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Cardioverter-defibrillator
- Keywords
- sudden cardiac death, risk assesment, HCM Risk-SCD Calculator
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioverter-defibrillatorDevice
We analyzed how many HCM patients reached an end-point of sudden cardiac death defined as adequate intervention of cardioverter-defibrillator or sudden cardiac arrest.
| Study group | Role | What they receive |
|---|---|---|
| Low risk | Low risk of sudden cardiac death according to HCM Risk-SCD Calculator Receives: Device: Cardioverter-defibrillator | |
| Intermediate risk | Intermediate risk of sudden cardiac death according to HCM Risk-SCD Calculator Receives: Device: Cardioverter-defibrillator | |
| High risk | High risk of sudden cardiac death according to HCM Risk-SCD Calculator Receives: Device: Cardioverter-defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden cardiac death (SCD) in risk groups
Number of SCD cases in each of risk groups according to HCM Risk-SCD Calculator
Measured: 2005-2018
Secondary outcomes (1)
New risk factors of sudden cardiac death (SCD)
New echocardiographic features, such as glibal longitudinal strain, average strain, left atrial volume index, which allow to better estimate the risk of SCD
Measured: 2005-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Oct 2014
- Primary completion1 Sep 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daria Adamczak, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402268
- Sponsor's protocol ID
- PoznanUMP
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not possible due to Polish law regulations.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04402268
- Acronym / sponsor ID
- PoznanUMP
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- sudden cardiac death, risk assesment, HCM Risk-SCD Calculator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 26 May 2020 (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.
Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. The disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (SCD) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign course. Therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (ICD) implantation.
Detailed description
Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. The disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (SCD) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign course. Therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (ICD) implantation.
This study assesses the accuracy of the HCM SCD-Risk Calculator, recommended by European Society of Cardiology guidelines, in patients treated in the Ist Department of Cardiology of Poznan University of Medical Sciences from 2005 to 2018.
The study group consisted of 252 patients aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6% were men. The protocol consisted of medical history collection (including a questionnaire), physical examination and additional tests such as echocardiography with the assessment of global longitudinal strain and average strain, cardiac magnetic resonance, ambulatory ECG monitoring, control of implantable devices and exercise testing.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low risk | – | Device: Cardioverter-defibrillatorLow risk of sudden cardiac death according to HCM Risk-SCD Calculator |
| Intermediate risk | – | Device: Cardioverter-defibrillatorIntermediate risk of sudden cardiac death according to HCM Risk-SCD Calculator |
| High risk | – | Device: Cardioverter-defibrillatorHigh risk of sudden cardiac death according to HCM Risk-SCD Calculator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group consisted of 252 patients with hypertrophic cardiomyopathy aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6% were men.
Key inclusion criteria (6 listed)
- Hypertrophic cardiomyopathy,
- Minimum 18 years,
- Questionnaire,
- Assessment of HCM SCD-Risk Calculator at the beginning of the observation,
- Regular visits in Cardiology Outpatient Clinic,
Key exclusion criteria (6 listed)
- Poorly controlled hypertension (systolic pressure on the next two visits in the Cardiology Outpatient Clinic >180 mmHg),
- Haemodynamically significant valvular heart disease or valve replacement condition,
- Past myocardial infarction (haemodynamically significant changes found in coronarography),
- Heart transplant,
- Insufficient amount of data from the subject and additional tests allowing for further analysis,
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 |
|---|---|---|
| Cardioverter-defibrillatorWe analyzed how many HCM patients reached an end-point of sudden cardiac death defined as adequate intervention of cardioverter-defibrillator or sudden cardiac arrest. | Device | High risk, Intermediate risk, Low risk |
Primary outcome
Sudden cardiac death (SCD) in risk groups
Time frame: 2005-2018
Number of SCD cases in each of risk groups according to HCM Risk-SCD Calculator
1 secondary outcome
New risk factors of sudden cardiac death (SCD)
Time frame: 2005-2018
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 26 May 2020.
- Individual participant dataSharing planned: No. Not possible due to Polish law regulations.
Related trials for Hypertrophic Cardiomyopathy
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
RecruitingPhase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001
Nonobstructive Hypertrophic Cardiomyopathy
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by Poznan University of Medical Sciences at 1 site in Poland.
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 6 inclusion and 6 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 26 May 2020. 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 Poland. 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?
Sudden cardiac death (SCD) in risk groups (time frame: 2005-2018). 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 26 May 2020.