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The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases (H²-Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04844944
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Leipzig Heart Institute GmbH

Brief Summary:
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.

Condition or disease
Heart Failure Coronary Artery Disease Atrial Fibrillation

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 24000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official 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
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Heart Failure
Hospitalized patients diagnosed with Heart Failure. No Intervention.
Coronary Artery Disease
Hospitalized patients diagnosed with Coronary Artery Disease. No Intervention.
Atrial Fibrillation
Hospitalized patients diagnosed with Atrial Fibrillation. No Intervention.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients being admitted as inpatients to a cardiology ward of one of the participating centers with one or more major cardiovascular disease entities (HF, CAD, AF)
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844944


Contacts
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Contact: Andreas Bollmann, MD, PhD +49 341 865-1413 Andreas.bollmann@helios-gesundheit.de

Locations
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Germany
Helios Klinikum Berlin-Buch Recruiting
Berlin, Germany, 13125
Contact: Henning Baberg, MD, PhD         
Helios Klinikum Erfurt Recruiting
Erfurt, Germany, 99089
Contact: Anja Schade, MD, PhD         
Helios Klinikum Gifhorn Recruiting
Gifhorn, Germany, 38518
Contact: Michael Niehaus, MD, PhD         
Helios Klinikum Hildesheim Recruiting
Hildesheim, Germany, 31135
Contact: Jürgen Tebbenjohanns, MD, PhD         
Heart Center Leipzig at University of Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Andreas Bollmann, MD, PhD         
Helios Vogtlandklinikum Plauen Recruiting
Plauen, Germany, 08529
Contact: Hans K Neuser, MD, PhD         
Helios Klinikum Schwerin Recruiting
Schwerin, Germany, 19049
Contact: Alexander Staudt, MD, PhD         
Helios Klinikum Siegburg Recruiting
Siegburg, Germany, 53721
Contact: Renè Andriè, MD, PhD         
Helios Dr. Horst Schmidt Kliniken Wiesbaden Recruiting
Wiesbaden, Germany, 65199
Contact: Markus Ferrari, MD, PhD         
Helios Universitätsklinikum Wuppertal Recruiting
Wuppertal, Germany, 42283
Contact: Melchior Seyfarth, MD, PhD         
Sponsors and Collaborators
Leipzig Heart Institute GmbH
Investigators
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Study Chair: Andreas Bollmann, MD, PhD Heart Center at University of Leipzig
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Responsible Party: Leipzig Heart Institute GmbH
ClinicalTrials.gov Identifier: NCT04844944    
Other Study ID Numbers: 2021-0016
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leipzig Heart Institute GmbH:
cardiovascular disease
HF
CAD
AF
ICHOM
Additional relevant MeSH terms:
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Atrial Fibrillation
Coronary Artery Disease
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases