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NCT Number: NCT04844944

The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases

Investigator-initiated, prospective, non-randomized, open label, non-interventional multicenter registry to evaluate current treatment of three major cardiovascular disease entities in clinical practice using a standardized variable-set of relevant covariates and outcome measures.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helios Klinikum Berlin-Buch, Berlin, Germany

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About this study

Heart failure (HF), coronary artery disease (CAD) and atrial fibrillation (AF) are among the most relevant cardiovascular diseases contributing to overall morbidity and mortality each itself and in particular in case of their coexistence. Several new therapies have been introduced in randomized controlled trials but confirmation data of treatment effects in real-world cohorts using a standardized methodology is scarce. The International Consortium for Health Outcomes Measurement (ICHOM) defined standard variable sets for all three diseases in order to objectively monitor the course of disease.

To evaluate current health care utilization and interactions between diseases and treatments in patients with HF, CAD and AF as well as patient-oriented values study initiator will build a prospective, observational, multicenter cardiovascular registry using standardized patient variables and endpoints based on the ICHOM recommendations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 18 years or older
  • Inpatient Treatment
  • Present diagnosis of at least one of the three cardiovascular disease entities of interest according to the current guidelines of the European Society of Cardiology (ESC): HF, CAD, AF

Exclusion criteria

  • Inability to provide informed consent
  • Initial presentation (index hospitalization) in cardiogenic shock or other kinds of shock
  • Patient after heart transplantation or patient with present ventricular assist device (VAD)

Treatment and study plan

Primary outcomes

  1. All-cause mortality during f/u

    Time frame: 6 months

  2. All-cause mortality during f/u

    Time frame: 12 months

  3. All-cause mortality during f/u

    Time frame: 18 months

Secondary outcomes

  1. in-hospital mortality

    Time frame: 3 days

  2. cardiovascular mortality during f/u

    Time frame: 6 months

  3. cardiovascular mortality during f/u

    Time frame: 12 months

  4. cardiovascular mortality during f/u

    Time frame: 18 months

  5. length of hospital stay

    Time frame: 3 days

  6. rate of rehospitalizations of any cause during f/u

    Time frame: 6 months

  7. rate of rehospitalizations of any cause during f/u

    Time frame: 12 months

  8. rate of rehospitalizations of any cause during f/u

    Time frame: 18 months

  9. rate of rehospitalizations for cardiovascular causes during f/u

    Time frame: 6 months

  10. rate of rehospitalizations for cardiovascular causes during f/u

    Time frame: 12 months

  11. rate of rehospitalizations for cardiovascular causes during f/u

    Time frame: 18 months

  12. rate of rehospitalizations for specific cardiovascular diseases

    Time frame: 6 months

  13. rate of rehospitalizations for specific cardiovascular diseases

    Time frame: 12 months

  14. rate of rehospitalizations for specific cardiovascular diseases

    Time frame: 18 months

  15. rate of specific cardiovascular events

    Time frame: 6 months

  16. rate of specific cardiovascular events

    Time frame: 12 months

  17. rate of specific cardiovascular events

    Time frame: 18 months

  18. general quality of life (PROMIS)

    Time frame: 6 months

  19. general quality of life (PROMIS)

    Time frame: 12 months

  20. general quality of life (PROMIS)

    Time frame: 18 months

  21. general quality of life (PHQ2)

    Time frame: 6 months

  22. general quality of life (PHQ2)

    Time frame: 12 months

  23. general quality of life (PHQ2)

    Time frame: 18 months

  24. disease specific quality of life (KCCQ-12 [HF])

    Time frame: 6 months

  25. disease specific quality of life (KCCQ-12 [HF])

    Time frame: 12 months

  26. disease specific quality of life (KCCQ-12 [HF])

    Time frame: 18 months

  27. disease specific quality of life (SAQ-7 [CAD])

    Time frame: 6 months

  28. disease specific quality of life (SAQ-7 [CAD])

    Time frame: 12 months

  29. disease specific quality of life (SAQ-7 [CAD])

    Time frame: 18 months

  30. disease specific quality of life (AFEQT [AF])

    Time frame: 6 months

  31. disease specific quality of life (AFEQT [AF])

    Time frame: 12 months

  32. disease specific quality of life (AFEQT [AF])

    Time frame: 18 months

  33. side effects associated with drug treatment

    Time frame: 6 months

    The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event or known side effect likely attributed to the heart failure related drug therapy leading to consultation of a medical facility or discontinuation of treatment that became apparent after the last study visit.

  34. side effects associated with drug treatment

    Time frame: 12 months

    The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event or known side effect likely attributed to the heart failure related drug therapy leading to consultation of a medical facility or discontinuation of treatment that became apparent after the last study visit.

  35. side effects associated with drug treatment

    Time frame: 18 months

    The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event or known side effect likely attributed to the heart failure related drug therapy leading to consultation of a medical facility or discontinuation of treatment that became apparent after the last study visit.

  36. complications associated with therapeutic interventions

    Time frame: 6 months

    The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event likely being associated with a heart failure related procedure (coronary revascularization, valve intervention / surgery, cardiac electronic device implantation) leading to prolonged hospital stay / additional therapeutic interventions / unplanned consultation of medical facilities.

  37. complications associated with therapeutic interventions

    Time frame: 12 months

    The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event likely being associated with a heart failure related procedure (coronary revascularization, valve intervention / surgery, cardiac electronic device implantation) leading to prolonged hospital stay / additional therapeutic interventions / unplanned consultation of medical facilities.

  38. complications associated with therapeutic interventions

    Time frame: 18 months

    The endpoint will be assessed by trained study personnel by the evaluation of patient interviews and medical records at each FU time point. The outcome is defined as any adverse event likely being associated with a heart failure related procedure (coronary revascularization, valve intervention / surgery, cardiac electronic device implantation) leading to prolonged hospital stay / additional therapeutic interventions / unplanned consultation of medical facilities.

  39. adherence to therapy

    Time frame: 6 months

    The endpoint will be assessed by trained study personnel by the evaluation of patient interviews at each FU time point. The outcome is defined as the accordance of prescribed and actually taken medication (from the last to the actual study visit) and will be presented as a ratio of the number of drug doses taken to the number of drug doses prescribed.

  40. adherence to therapy

    Time frame: 12 months

    The endpoint will be assessed by trained study personnel by the evaluation of patient interviews at each FU time point. The outcome is defined as the accordance of prescribed and actually taken medication (from the last to the actual study visit) and will be presented as a ratio of the number of drug doses taken to the number of drug doses prescribed.

  41. adherence to therapy

    Time frame: 18 months

    The endpoint will be assessed by trained study personnel by the evaluation of patient interviews at each FU time point. The outcome is defined as the accordance of prescribed and actually taken medication (from the last to the actual study visit) and will be presented as a ratio of the number of drug doses taken to the number of drug doses prescribed.

  42. disease associated treatment costs

    Time frame: 6 months

  43. disease associated treatment costs

    Time frame: 12 months

  44. disease associated treatment costs

    Time frame: 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Bollmann, MD, PhD

CONTACT

[email protected]

+49 341 865-1413

Sponsors and collaborators

Lead sponsor

Helios Health Institute GmbH

Other

Registry information

Official study title

The Helios Heart Registry: A Standardized Registry for Capturing Clinical and Patient-reported Outcomes in Patients With Specific Cardiac Diseases: Application of the ICHOM Standard in Clinical Practice

Acronym: H²-Registry

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2021
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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