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

October 7, 2024 updated by: Helios Health Institute GmbH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Active, not recruiting
        • Helios Klinikum Berlin-Buch
      • Erfurt, Germany, 99089
        • Active, not recruiting
        • Helios Klinikum Erfurt
      • Gifhorn, Germany, 38518
        • Active, not recruiting
        • Helios Klinikum Gifhorn
      • Hildesheim, Germany, 31135
        • Recruiting
        • Helios Klinikum HIldesheim
        • Contact:
          • Jürgen Tebbenjohanns, MD, PhD
      • Leipzig, Germany, 04289
        • Active, not recruiting
        • Heart Center Leipzig at University of Leipzig
      • Plauen, Germany, 08529
        • Active, not recruiting
        • Helios Vogtlandklinikum Plauen
      • Schwerin, Germany, 19049
        • Recruiting
        • HELIOS Klinikum Schwerin
        • Contact:
          • Alexander Staudt, MD, PhD
      • Siegburg, Germany, 53721
        • Active, not recruiting
        • Helios Klinikum Siegburg
      • Wiesbaden, Germany, 65199
        • Recruiting
        • Helios Dr. Horst Schmidt Kliniken Wiesbaden
        • Contact:
          • Markus Ferrari, MD, PhD
      • Wuppertal, Germany, 42283
        • Recruiting
        • Helios Universitätsklinikum Wuppertal
        • Contact:
          • Melchior Seyfarth, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All-cause mortality during f/u
Time Frame: 6 months
6 months
All-cause mortality during f/u
Time Frame: 12 months
12 months
All-cause mortality during f/u
Time Frame: 18 months
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
in-hospital mortality
Time Frame: 3 days
3 days
cardiovascular mortality during f/u
Time Frame: 6 months
6 months
cardiovascular mortality during f/u
Time Frame: 12 months
12 months
cardiovascular mortality during f/u
Time Frame: 18 months
18 months
length of hospital stay
Time Frame: 3 days
3 days
rate of rehospitalizations of any cause during f/u
Time Frame: 6 months
6 months
rate of rehospitalizations of any cause during f/u
Time Frame: 12 months
12 months
rate of rehospitalizations of any cause during f/u
Time Frame: 18 months
18 months
rate of rehospitalizations for cardiovascular causes during f/u
Time Frame: 6 months
6 months
rate of rehospitalizations for cardiovascular causes during f/u
Time Frame: 12 months
12 months
rate of rehospitalizations for cardiovascular causes during f/u
Time Frame: 18 months
18 months
rate of rehospitalizations for specific cardiovascular diseases
Time Frame: 6 months
6 months
rate of rehospitalizations for specific cardiovascular diseases
Time Frame: 12 months
12 months
rate of rehospitalizations for specific cardiovascular diseases
Time Frame: 18 months
18 months
rate of specific cardiovascular events
Time Frame: 6 months
6 months
rate of specific cardiovascular events
Time Frame: 12 months
12 months
rate of specific cardiovascular events
Time Frame: 18 months
18 months
general quality of life (PROMIS)
Time Frame: 6 months
6 months
general quality of life (PROMIS)
Time Frame: 12 months
12 months
general quality of life (PROMIS)
Time Frame: 18 months
18 months
general quality of life (PHQ2)
Time Frame: 6 months
6 months
general quality of life (PHQ2)
Time Frame: 12 months
12 months
general quality of life (PHQ2)
Time Frame: 18 months
18 months
disease specific quality of life (KCCQ-12 [HF])
Time Frame: 6 months
6 months
disease specific quality of life (KCCQ-12 [HF])
Time Frame: 12 months
12 months
disease specific quality of life (KCCQ-12 [HF])
Time Frame: 18 months
18 months
disease specific quality of life (SAQ-7 [CAD])
Time Frame: 6 months
6 months
disease specific quality of life (SAQ-7 [CAD])
Time Frame: 12 months
12 months
disease specific quality of life (SAQ-7 [CAD])
Time Frame: 18 months
18 months
disease specific quality of life (AFEQT [AF])
Time Frame: 6 months
6 months
disease specific quality of life (AFEQT [AF])
Time Frame: 12 months
12 months
disease specific quality of life (AFEQT [AF])
Time Frame: 18 months
18 months
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.
6 months
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.
12 months
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.
18 months
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.
6 months
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.
12 months
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.
18 months
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.
6 months
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.
12 months
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.
18 months
disease associated treatment costs
Time Frame: 6 months
6 months
disease associated treatment costs
Time Frame: 12 months
12 months
disease associated treatment costs
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helios Health Institute GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Andreas Bollmann, MD, PhD, Heart Center at University of Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-0016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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