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Terminated OBSERVATIONAL NCT01823211

Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients (HAPPIER)

Heart Rate Variability, Microvolt T-wave Alternans and Cardiac Magnetic Resonance Imaging Analysis in Primary Preventive ImplantablE Cardioverter-defibrillator Recipients Profitability Trial - HAPPIER Trial

Sponsor: Brno University Hospital

Updated 8 times since 2017 Last updated: Oct 27, 2016 Started: Mar 31, 2013 Primary completion: Dec 31, 2015 Completion: Apr 30, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Problems with ensuring patient examinations defined in the protocol of the study

This observational or N/A phase trial investigates Ischaemic Cardiomyopathy and Non-ischaemic Cardiomyopathy and is currently terminated or withdrawn. Brno University Hospital leads this study, which shows 8 recorded versions since 2013 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotTerminated~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 7 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated

  2. Sep 2025 — Present [monthly]

    Terminated

  3. Sep 2024 — Sep 2025 [monthly]

    Terminated

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated

  5. Jan 2021 — Jul 2024 [monthly]

    Terminated

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Terminated

  2. Apr 2018 — Jun 2018 [monthly]

    Terminated

    Phase: NANone

  3. Jan 2017 — Apr 2018 [monthly]

    Terminated NA

    First recorded

Mar 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Brno University Hospital
  • University Hospital Olomouc
  • University Hospital Ostrava
Data source: University Hospital Ostrava

For direct contact, visit the study record on ClinicalTrials.gov .