Heart FailureH²-RegistryNCT04844944
The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases
An observational study of Heart Failure and Coronary Artery Disease, run by Helios Health Institute GmbH at 10 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Coronary Artery Disease, Atrial Fibrillation
- How many people
- 24,000 participants
- Where
- 10 sitesGermany
- Study dates
- 30 Mar 2021to 1 Mar 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Germany10 sites, 4 recruiting
- Active, not recruiting
Helios Klinikum Berlin-Buch
Berlin, 13125
- Active, not recruiting
Helios Klinikum Erfurt
Erfurt, 99089
- Active, not recruiting
Helios Klinikum Gifhorn
Gifhorn, 38518
- Recruiting
Helios Klinikum Hildesheim
Hildesheim, 31135
Jürgen Tebbenjohanns, MD, PhD
- Active, not recruiting
Heart Center Leipzig at University of Leipzig
Leipzig, 04289
- Active, not recruiting
Helios Vogtlandklinikum Plauen
Plauen, 08529
- Recruiting
Helios Klinikum Schwerin
Schwerin, 19049
Alexander Staudt, MD, PhD
- Active, not recruiting
Helios Klinikum Siegburg
Siegburg, 53721
- Recruiting
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, 65199
Markus Ferrari, MD, PhD
- Recruiting
Helios Universitätsklinikum Wuppertal
Wuppertal, 42283
Melchior Seyfarth, MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Coronary Artery Disease, Atrial Fibrillation
- Keywords
- cardiovascular disease, HF, CAD, AF, ICHOM
- Medical subject headings
- Heart Failure, Coronary Artery Disease, Atrial Fibrillation, Cardiovascular Diseases
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality during f/u
Measured: 6 months
All-cause mortality during f/u
Measured: 12 months
All-cause mortality during f/u
Measured: 18 months
Secondary outcomes (44)
in-hospital mortality
Measured: 3 days
cardiovascular mortality during f/u
Measured: 6 months
cardiovascular mortality during f/u
Measured: 12 months
cardiovascular mortality during f/u
Measured: 18 months
length of hospital stay
Measured: 3 days
rate of rehospitalizations of any cause during f/u
Measured: 6 months
rate of rehospitalizations of any cause during f/u
Measured: 12 months
rate of rehospitalizations of any cause during f/u
Measured: 18 months
rate of rehospitalizations for cardiovascular causes during f/u
Measured: 6 months
rate of rehospitalizations for cardiovascular causes during f/u
Measured: 12 months
rate of rehospitalizations for cardiovascular causes during f/u
Measured: 18 months
rate of rehospitalizations for specific cardiovascular diseases
Measured: 6 months
rate of rehospitalizations for specific cardiovascular diseases
Measured: 12 months
rate of rehospitalizations for specific cardiovascular diseases
Measured: 18 months
rate of specific cardiovascular events
Measured: 6 months
rate of specific cardiovascular events
Measured: 12 months
rate of specific cardiovascular events
Measured: 18 months
general quality of life (PROMIS)
Measured: 6 months
general quality of life (PROMIS)
Measured: 12 months
general quality of life (PROMIS)
Measured: 18 months
general quality of life (PHQ2)
Measured: 6 months
general quality of life (PHQ2)
Measured: 12 months
general quality of life (PHQ2)
Measured: 18 months
disease specific quality of life (KCCQ-12 [HF])
Measured: 6 months
disease specific quality of life (KCCQ-12 [HF])
Measured: 12 months
disease specific quality of life (KCCQ-12 [HF])
Measured: 18 months
disease specific quality of life (SAQ-7 [CAD])
Measured: 6 months
disease specific quality of life (SAQ-7 [CAD])
Measured: 12 months
disease specific quality of life (SAQ-7 [CAD])
Measured: 18 months
disease specific quality of life (AFEQT [AF])
Measured: 6 months
disease specific quality of life (AFEQT [AF])
Measured: 12 months
disease specific quality of life (AFEQT [AF])
Measured: 18 months
side effects associated with drug treatment
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.
Measured: 6 months
side effects associated with drug treatment
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.
Measured: 12 months
side effects associated with drug treatment
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.
Measured: 18 months
complications associated with therapeutic interventions
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.
Measured: 6 months
complications associated with therapeutic interventions
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.
Measured: 12 months
complications associated with therapeutic interventions
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.
Measured: 18 months
adherence to therapy
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.
Measured: 6 months
adherence to therapy
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.
Measured: 12 months
adherence to therapy
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.
Measured: 18 months
disease associated treatment costs
Measured: 6 months
disease associated treatment costs
Measured: 12 months
disease associated treatment costs
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start30 Mar 2021
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
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 Heart FailureStudies 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
- 24,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Bollmann, MD, PhD, Study chair, Heart Center at University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844944
- Sponsor's protocol ID
- 2021-0016
- Acronym
- H²-Registry
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2021
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leiner J, Hohenstein S, Konig S, Kwast S, Nitsche A, Seyfarth M, Baberg H, Lauten A, Neuser H, Staudt A, Tebbenjohanns J, Andrie R, Niehaus M, Ferrari MW, Muller M, Schulte N, Bode K, Kuhlen R, Bollmann A. Characteristics and outcomes of patients with heart failure and reduced left ventricular ejection fraction in relation to sodium-glucose cotransporter-2 inhibitor treatment: real-world data from the multicentre H2-registry. Clin Res Cardiol. 2026 Feb 2. doi: 10.1007/s00392-026-02853-2. Online ahead of print.
PubMed 41627441Leiner J, Konig S, Nitsche A, Hohenstein S, Nagel J, Seyfarth M, Baberg H, Lauten A, Neuser H, Staudt A, Tebbenjohanns J, Andrie R, Niehaus M, Ferrari MW, Kuhlen R, Bollmann A. A multicentre registry of hospitalized patients with acute and chronic heart failure: Study design of the H2-registry. ESC Heart Fail. 2025 Aug;12(4):3114-3133. doi: 10.1002/ehf2.15266. Epub 2025 Apr 13.
PubMed 40222816
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04844944
- Acronym / sponsor ID
- H²-Registry / 2021-0016
- Conditions
- Heart Failure, Coronary Artery Disease, Atrial Fibrillation
- Keywords
- cardiovascular disease, HF, CAD, AF, ICHOM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24,000 participants (estimated)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 14 Apr 2021 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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
All-cause mortality during f/u
Time frame: 6 months
All-cause mortality during f/u
Time frame: 12 months
All-cause mortality during f/u
Time frame: 18 months
44 secondary outcomes
in-hospital mortality
Time frame: 3 days
cardiovascular mortality during f/u
Time frame: 6 months
cardiovascular mortality during f/u
Time frame: 12 months
cardiovascular mortality during f/u
Time frame: 18 months
length of hospital stay
Time frame: 3 days
rate of rehospitalizations of any cause during f/u
Time frame: 6 months
rate of rehospitalizations of any cause during f/u
Time frame: 12 months
rate of rehospitalizations of any cause during f/u
Time frame: 18 months
rate of rehospitalizations for cardiovascular causes during f/u
Time frame: 6 months
rate of rehospitalizations for cardiovascular causes during f/u
Time frame: 12 months
rate of rehospitalizations for cardiovascular causes during f/u
Time frame: 18 months
rate of rehospitalizations for specific cardiovascular diseases
Time frame: 6 months
rate of rehospitalizations for specific cardiovascular diseases
Time frame: 12 months
rate of rehospitalizations for specific cardiovascular diseases
Time frame: 18 months
rate of specific cardiovascular events
Time frame: 6 months
rate of specific cardiovascular events
Time frame: 12 months
rate of specific cardiovascular events
Time frame: 18 months
general quality of life (PROMIS)
Time frame: 6 months
general quality of life (PROMIS)
Time frame: 12 months
general quality of life (PROMIS)
Time frame: 18 months
general quality of life (PHQ2)
Time frame: 6 months
general quality of life (PHQ2)
Time frame: 12 months
general quality of life (PHQ2)
Time frame: 18 months
disease specific quality of life (KCCQ-12 [HF])
Time frame: 6 months
disease specific quality of life (KCCQ-12 [HF])
Time frame: 12 months
disease specific quality of life (KCCQ-12 [HF])
Time frame: 18 months
disease specific quality of life (SAQ-7 [CAD])
Time frame: 6 months
disease specific quality of life (SAQ-7 [CAD])
Time frame: 12 months
disease specific quality of life (SAQ-7 [CAD])
Time frame: 18 months
disease specific quality of life (AFEQT [AF])
Time frame: 6 months
disease specific quality of life (AFEQT [AF])
Time frame: 12 months
disease specific quality of life (AFEQT [AF])
Time frame: 18 months
side effects associated with drug treatment
Time frame: 6 months
side effects associated with drug treatment
Time frame: 12 months
side effects associated with drug treatment
Time frame: 18 months
complications associated with therapeutic interventions
Time frame: 6 months
complications associated with therapeutic interventions
Time frame: 12 months
complications associated with therapeutic interventions
Time frame: 18 months
adherence to therapy
Time frame: 6 months
adherence to therapy
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 41627441Leiner J, Hohenstein S, Konig S, Kwast S, Nitsche A, Seyfarth M, Baberg H, Lauten A, Neuser H, Staudt A, Tebbenjohanns J, Andrie R, Niehaus M, Ferrari MW, Muller M, Schulte N, Bode K, Kuhlen R, Bollmann A. Characteristics and outcomes of patients with heart failure and reduced left ventricular ejection fraction in relation to sodium-glucose cotransporter-2 inhibitor treatment: real-world data from the multicentre H2-registry. Clin Res Cardiol. 2026 Feb 2. doi: 10.1007/s00392-026-02853-2. Online ahead of print.
- Derived from this study: PubMed 40222816Leiner J, Konig S, Nitsche A, Hohenstein S, Nagel J, Seyfarth M, Baberg H, Lauten A, Neuser H, Staudt A, Tebbenjohanns J, Andrie R, Niehaus M, Ferrari MW, Kuhlen R, Bollmann A. A multicentre registry of hospitalized patients with acute and chronic heart failure: Study design of the H2-registry. ESC Heart Fail. 2025 Aug;12(4):3114-3133. doi: 10.1002/ehf2.15266. Epub 2025 Apr 13.
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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.
Andreas Bollmann, MD, PhD study chair
Heart Center at University of Leipzig
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Coronary Artery Disease, run by Helios Health Institute GmbH at 10 sites in Germany.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Bollmann, MD, PhD (+49 341 865-1413, Andreas.bollmann@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality during f/u (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04844944, 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 9 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.