Ischaemic CardiomyopathyHAPPIERNCT01823211
Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients
An observational study of Ischaemic Cardiomyopathy and Non-ischaemic Cardiomyopathy, run by University Hospital Ostrava at 3 sites in Czechia.
Trial summary
The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischaemic Cardiomyopathy, Non-ischaemic Cardiomyopathy
- How many people
- 50 participants
- Where
- 3 sitesCzechia
- Study dates
- Mar 2013to Apr 2016
- How long will I take part?
- 36 Months
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart-failure clinic,primary care clinic
Who may be able to join
- LVD (left ventricular dysfunction) d/t MI (Myocardial infarction), LVEF 30% or less, NYHA (New York Heart association class) II, III
- LVD d/t MI, LVEF 30% to 35%, NYHA II, III
- LVD d/t MI, LVEF 30% to 40%, NSVT, positive EP study
- LVD d/t MI, LVEF 30% or less, NYHA I
- NICM (non-ischaemic cardiomyopathy), LVEF 30% or less, NYHA II, III
- NICM, LVEF 30% to 35%, NYHA II, III
- NICM, LVEF 30% or less, NYHA I
- signed informed consent
Who cannot join
- metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
- severe claustrophobia may not be able to tolerate an MRI scan
- heart rhythm device in place before enrollment
- atrial fibrillation in time of enrollment
- ICD implantation indicated from secondary prevention of SCD (sudden cardiac death)
- NYHA or CCS class IV
Show all 9Show fewer
- PCI or CABG in last 3 months
- CMP/TIA in last 3 months
- syncope of unknown etiology
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
Brno University Hospital
Brno, 62500
University Hospital Olomouc
Olomouc, 775 20
University Hospital Ostrava
Ostrava, 70852
About this study
Official title: Heart Rate Variability, Microvolt T-wave Alternans and Cardiac Magnetic Resonance Imaging Analysis in Primary Preventive ImplantablE Cardioverter-defibrillator Recipients Profitability Trial - HAPPIER Trial
The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death.
Read the detailed description
Current criteria for risk stratification of patients in risk of sudden cardiac death are mainly based on left ventricular ejection fraction and NYHA class. This criteria are too robust, approximately 2/3 of ICD recipients do not profit from this treatment in the following 5 years, especially those with non-ischaemic cardiomyopathy. We plan to sub-stratify this group of patients with both ischaemic and non-ischaemic cardiomyopathy by: non-linear heart rate variability analysis, microvolt T-wave alternans, QRT-T angle and character and amount of left ventricular scarring assessed by magnetic resonance imaging. Pre-implantation values will be correlated with numbers and character of ICD therapy (both anti-tachycardial pacing and ICD discharge). The results may allow to decrease the number of patients, who do not profit from ICD treatment.
- Keywords
- ICD (Implantable cardioverter-defibrillator), Heart rate variability, MTWA (Microvolt T-alternans), Magnetic resonance imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ischaemic cardiomyopathy | EP (Electrophysiology) study,magnetic resonance with LGE (Late gadolinium enhancement), ICD implantation | |
| non-ischaemic cardiomyopathy | EP study,magnetic resonance imaging with LGE, ICD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventricular tachyarrhytmia
ventricular tachycardia equal or > 250/min,ventricular fibrillation, arrhythmic storm
Measured: 36 months
Secondary outcomes (1)
sudden cardiac death
death in 24-hours after symptom onset
Measured: 36-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionApr 2016
Why it stopped: Problems with ensuring patient examinations defined in the protocol of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischaemic 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
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Olomouc, Brno University Hospital
- Responsible party
- Sponsor
- Investigators
- Jiri Plasek, MD, PhD, Study director, Department of Cardiology,University hospital OstravaMilos Taborsky, MD, PhD, FESC, Study chair, Department of Cardiology,University Hospital OlomoucLubos Krivan, MD, PhD, Principal investigator, Department of Cardiology,University Hospital Brno-BohuniceOndrej Moravec, MD, Principal investigator, Department of Cardiology,University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823211
- Sponsor's protocol ID
- FNO-KVO-2
- Other IDs
- Plasek680-2
- Acronym
- HAPPIER
- Status last verified
- Oct 2016
- First submitted
- 19 Mar 2013
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Seely AJ, Macklem PT. Complex systems and the technology of variability analysis. Crit Care. 2004 Dec;8(6):R367-84. doi: 10.1186/cc2948. Epub 2004 Sep 22.
PubMed 15566580Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace. 2006 Sep;8(9):746-837. doi: 10.1093/europace/eul108. Epub 2006 Aug 25. No abstract available.
PubMed 16935866
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability, Microvolt T-wave Alternans and Cardiac Magnetic Resonance Imaging Analysis in Primary Preventive ImplantablE Cardioverter-defibrillator Recipients Profitability Trial - HAPPIER Trial
- ClinicalTrials.gov ID
- NCT01823211
- Acronym / sponsor ID
- HAPPIER / FNO-KVO-2
- Keywords
- ICD (Implantable cardioverter-defibrillator), Heart rate variability, MTWA (Microvolt T-alternans), Magnetic resonance imaging (MRI)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Problems with ensuring patient examinations defined in the protocol of the study
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University Hospital Olomouc, Brno University Hospital
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Apr 2013 (estimated)
- 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.
The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death.
Detailed description
Current criteria for risk stratification of patients in risk of sudden cardiac death are mainly based on left ventricular ejection fraction and NYHA class. This criteria are too robust, approximately 2/3 of ICD recipients do not profit from this treatment in the following 5 years, especially those with non-ischaemic cardiomyopathy. We plan to sub-stratify this group of patients with both ischaemic and non-ischaemic cardiomyopathy by: non-linear heart rate variability analysis, microvolt T-wave alternans, QRT-T angle and character and amount of left ventricular scarring assessed by magnetic resonance imaging. Pre-implantation values will be correlated with numbers and character of ICD therapy (both anti-tachycardial pacing and ICD discharge). The results may allow to decrease the number of patients, who do not profit from ICD treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ischaemic cardiomyopathy | – | –EP (Electrophysiology) study,magnetic resonance with LGE (Late gadolinium enhancement), ICD implantation |
| non-ischaemic cardiomyopathy | – | –EP study,magnetic resonance imaging with LGE, ICD implantation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart-failure clinic,primary care clinic
Key inclusion criteria (8 listed)
- LVD (left ventricular dysfunction) d/t MI (Myocardial infarction), LVEF 30% or less, NYHA (New York Heart association class) II, III
- LVD d/t MI, LVEF 30% to 35%, NYHA II, III
- LVD d/t MI, LVEF 30% to 40%, NSVT, positive EP study
- LVD d/t MI, LVEF 30% or less, NYHA I
- NICM (non-ischaemic cardiomyopathy), LVEF 30% or less, NYHA II, III
Key exclusion criteria (9 listed)
- metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
- severe claustrophobia may not be able to tolerate an MRI scan
- heart rhythm device in place before enrollment
- atrial fibrillation in time of enrollment
- ICD implantation indicated from secondary prevention of SCD (sudden cardiac death)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ventricular tachyarrhytmia
Time frame: 36 months
ventricular tachycardia equal or > 250/min,ventricular fibrillation, arrhythmic storm
1 secondary outcome
sudden cardiac death
Time frame: 36-months
Results and safety
The study was stopped early (reason given: Problems with ensuring patient examinations defined in the protocol of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Background: PubMed 15566580Seely AJ, Macklem PT. Complex systems and the technology of variability analysis. Crit Care. 2004 Dec;8(6):R367-84. doi: 10.1186/cc2948. Epub 2004 Sep 22.
- Background: PubMed 16935866Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace. 2006 Sep;8(9):746-837. doi: 10.1093/europace/eul108. Epub 2006 Aug 25. No abstract available.
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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.
Jiri Plasek, MD, PhD study director
Department of Cardiology,University hospital Ostrava
Milos Taborsky, MD, PhD, FESC study chair
Department of Cardiology,University Hospital Olomouc
Lubos Krivan, MD, PhD principal investigator
Department of Cardiology,University Hospital Brno-Bohunice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischaemic Cardiomyopathy and Non-ischaemic Cardiomyopathy, run by University Hospital Ostrava at 3 sites in Czechia.
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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. 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 was stopped early (reason given: Problems with ensuring patient examinations defined in the protocol of the study). Results are not available in the source record.
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?
ventricular tachyarrhytmia (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01823211, which also lists 2 linked publications.
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 28 Oct 2016.