Heart FailureCONNECTNCT06004453
Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care
An observational study of Heart Failure, run by Novartis Pharmaceuticals at 94 sites in Germany.
Trial summary
This was a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (HFrEF) patient treatment and care following a decompensation event in different types of Heart Failure Unit (HFU) or non-HFU centers… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart Failure medications
- How many people
- 899 participants
- Where
- 94 sitesGermany
- Study dates
- 3 Apr 2023to 17 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure with reduced ejection fraction patients with a recent decompensation event
Who may be able to join
- Patients who provide written informed consent to participate in the study
- Male or female patients ≥ 18 years of age
- Patients with diagnosis of heart failure with reduced ejection fraction (HFrEF) and HF treatment according to the summaries of product characteristics (SmPCs)
- Decompensation event up to three months prior to inclusion
Who cannot join
- Simultaneous or planned participation in an interventional research study
- Participation in this study at another site e.g. in a HFU network
- Patients incapable of understanding and signing the informed consent form
Trial locations and contacts
94 sites in 1 country.
94 sites in 1 country
Germany94 sites
Novartis Investigative Site
Aichach, 86551
Novartis Investigative Site
Amberg, 92224
Novartis Investigative Site
Bad Homburg, 61348
Novartis Investigative Site
Bad Neustadt an der Saale, 97616
Novartis Investigative Site
Bad Vilbel, 61118
Novartis Investigative Site
Bechhofen, 66894
Novartis Investigative Site
Berlin, State of Berlin, 10365
Novartis Investigative Site
Berlin, 10559
Novartis Investigative Site
Berlin, 13053
Novartis Investigative Site
Bexbach, 66450
Novartis Investigative Site
Biedenkopf, 35216
Novartis Investigative Site
Bitterfeld-Wolfen, 06749
Novartis Investigative Site
Braunschweig, Lower Saxony, 38126
Novartis Investigative Site
Breuberg, 64747
Novartis Investigative Site
Brilon, 59929
Novartis Investigative Site
Bruchsal, 76646
Novartis Investigative Site
Brüel, 19412
Novartis Investigative Site
Chemnitz, Saxony, 09113
Novartis Investigative Site
Coburg, 96450
Novartis Investigative Site
Coswig, 06869
Novartis Investigative Site
Dessau, 06847
Novartis Investigative Site
Dinkelsbühl, 91550
Novartis Investigative Site
Dresden, 01277
Novartis Investigative Site
Dresden, 01397
Novartis Investigative Site
Düsseldorf, 40217
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Ehingen, 89584
Novartis Investigative Site
Erfurt, 99097
Novartis Investigative Site
Farchant, 82490
Novartis Investigative Site
Frankenthal, Rhineland-Palatinate, 67227
Novartis Investigative Site
Frankfurt am Main, Hesse, 60590
Novartis Investigative Site
Freiberg, 09559
Novartis Investigative Site
Fulda, 36037
Novartis Investigative Site
Gera, Thuringia, 07551
Novartis Investigative Site
Giengen an der Brenz, 89537
Novartis Investigative Site
Göppingen, 73033
Novartis Investigative Site
Hagen, 58135
Novartis Investigative Site
Halle, Saxony-Anhalt, 06120
Novartis Investigative Site
Hamburg, 20095
Novartis Investigative Site
Hamburg, 22087
Novartis Investigative Site
Heidelberg, Baden-Wurttemberg, 69115
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Hoppegarten, 15366
Novartis Investigative Site
Ingelheim, Rhineland-Palatinate, 55218
Novartis Investigative Site
Jerichow, Saxony-Anhalt, 39319
Novartis Investigative Site
Kaiserslautern, Rhineland-Palatinate, 67655
Novartis Investigative Site
Kaiserslautern, Rhineland-Palatinate, 67657
Novartis Investigative Site
Kassel, Hesse, 34121
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Kiel, 24106
Novartis Investigative Site
Kitzingen, 97318
Novartis Investigative Site
Kleinblittersdorf, Saarland, 66271
Novartis Investigative Site
Kleve, 47533
Novartis Investigative Site
Leipzig, Saxony, 04209
Novartis Investigative Site
Leipzig, 04129
Novartis Investigative Site
Limbach-Oberfrohna, Saxony, 09212
Novartis Investigative Site
Löhne, North Rhine-Westphalia, 32584
Novartis Investigative Site
Lübeck, 23569
Novartis Investigative Site
Ludwigsburg, Baden-Wurttemberg, 71640
Novartis Investigative Site
Ludwigshafen, 67067
Novartis Investigative Site
Magdeburg, 39120
Novartis Investigative Site
Markkleeberg, 04416
Novartis Investigative Site
Moers, 47441
Novartis Investigative Site
Muellheim Im Markgraeflerland, Baden-Wurttemberg, 79379
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Osnabrück, 49074
Novartis Investigative Site
Papenburg, 26871
Novartis Investigative Site
Pirna, Saxony, 01796
Novartis Investigative Site
Potsdam, 14471
Novartis Investigative Site
Radebeul, 01445
Novartis Investigative Site
Rastatt, 76437
Novartis Investigative Site
Remscheid, 42859
Novartis Investigative Site
Rostock, 18107
Novartis Investigative Site
Rotenburg an der Fulda, 36199
Novartis Investigative Site
Rudersberg, 73635
Novartis Investigative Site
Schönebeck, 39218
Novartis Investigative Site
Schwandorf in Bayern, 92421
Novartis Investigative Site
Siegen, 57072
Novartis Investigative Site
Speyer, 67346
Novartis Investigative Site
Stadtlohn, 48703
Novartis Investigative Site
Stahnsdorf, 14532
Novartis Investigative Site
Stuttgart, 70376
Novartis Investigative Site
Ulm, 89077
Novartis Investigative Site
Urbach, 99765
Novartis Investigative Site
Wedemark, 30900
Novartis Investigative Site
Wermsdorf, 04779
Novartis Investigative Site
Wiesbaden, D-65199
Novartis Investigative Site
Winsen, Lower Saxony, 21423
Novartis Investigative Site
Winsen, 21423
Novartis Investigative Site
Wismar, 23966
Novartis Investigative Site
Wittenberg, 06886
Novartis Investigative Site
Wolfsburg, 38440
Novartis Investigative Site
Würzburg, 97080
About this study
Official title: Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care in Heart Failure Units and Independent Centers Utilizing Established Quality Indicators
This was a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (HFrEF) patient treatment and care following a decompensation event in different types of Heart Failure Unit (HFU) or non-HFU centers across Germany.
Read the detailed description
This study aimed to describe quality of care of HFrEF patients following a decompensation event in different center types (=settings) utilizing the quality indicators for the care and outcomes of adults with heart failure as specified by the Heart Failure Association in 2022.
No strict visit schedule was imposed on participants to avoid interference with routine clinical care. HFrEF patients were treated according to the local routine in terms of medication, visit frequency and types of assessments performed and only these data was collected as part of the study from patient files.
- Conditions
- Heart Failure
- Being tested
- Heart Failure medications
- Keywords
- Heart Failure, HFrEF, patient management, quality of care, quality indicators
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Failure medicationsOther
There was no treatment allocation. Patients were allocated to the respective cohort based on the treating physician enrolling them in the study. Patients were treated according to the local prescribing information and routine medical practice.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Supra-regional HFU Centers and HFU Focus Hospitals Receives: Other: Heart Failure medications | |
| Cohort B | Non-HFU Hospitals Receives: Other: Heart Failure medications | |
| Cohort C | HFU Residential Cardiologists Receives: Other: Heart Failure medications | |
| Cohort D | Non-HFU Residential Cardiologists Receives: Other: Heart Failure medications | |
| Cohort E | General practitioners Receives: Other: Heart Failure medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint
Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based QI composite endpoint defined by the number of times each of secondary endpoints has been accomplished divided by chances to accomplish them as average per center type.
To describe the quality of Heart Failure (HF) patient care in Heart Failure Unit (HFU) and non-HFU centers utilizing QIs as suggested by the 2021 European Society of Cardiology HF guideline.
Measured: 6 months
Secondary outcomes (26)
Proportion of sites with a dedicated multidisciplinary team to manage patients with HF
To describe the structural framework of the participating centers.
Measured: Baseline
Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care.
To describe the structural framework of the participating centers.
Measured: Baseline
(A) Proportion of patients with HF who have a documentation of their HF clinical type
HF clinical type: Heart failure with reduced ejection fraction (HFrEF), HF with a midrange ejection fraction (HFmrEF), HF with preserved ejection fraction (HFpEF).
To describe the patient assessment in different types of HFU and non-HFU centers.
Measured: Baseline
(B) Proportion of patients with a documentation of their electrocardiogram findings
To describe the patient assessment in different types of HFU and non-HFU centers.
Measured: 6 months
(C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation)
To describe the patient assessment in different types of HFU and non-HFU centers.
Measured: 3 months
(D) Proportion of patients who have their blood tests documented
To describe the patient assessment in different types of HFU and non-HFU centers.
Measured: 3 months
(E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program
To describe the patient assessment in different types of HFU and non-HFU centers.
Measured: 6 months
(F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge
To describe the patient assessment in different types of HFU and non-HFU centers.
Measured: 4 weeks
(G) Proportion of patients treated with beta-blocker bisoprolol, carvedilol, sustained-release metoprolol succinate, or nebivolol in the absence of any contraindications as defined by Aktaa et al 2022
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Measured: 6 months
(H) Proportion of patients treated with an Angiotensin-converting enzymes (ACE) inhibitor, Angiotensin receptor blocker (ARB) or Angiotensin receptor-neprilysin inhibitor (ARNI) in the absence of any contraindications
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Measured: 6 months
(I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Measured: 6 months
(J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Measured: 6 months
Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Measured: 6 months
Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Measured: 6 months
Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Measured: 6 months
Percentage of days covered with all four treatment classes
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Measured: 6 months
(K) Proportion of symptomatic patients with HFrEF in sinus rhythm with a QRS duration ≥150ms and left bundle branch block QRS morphology and with LVEF ≤35% despite ≥3 months optimal medical therapy who are offered cardiac resynchronization therapy
To describe the therapy optimization in different types of HFU and non-HFU centers.
Measured: 6 months
(L) Proportion of symptomatic patients with HF, LVEF ≤35% despite ≥3 months of optimal medical therapy, and ischemic heart disease (IHD) who are offered primary prevention implantable cardioverter defibrillator
To describe the therapy optimization in different types of HFU and non-HFU centers.
Measured: 6 months
Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool
To describe the utilization of HRQoL assessments in different types of HFU and non-HFU centers.
Measured: 6 months
Number of patients who are eligible for and have accomplished secondary endpoint g-j divided by the number of patients who are eligible for g-j
To describe quality of treatment utilizing an all-or-none composite QI.
Measured: 6 months
Number of HF hospitalizations, stratified by bed type
Where a patient had multiple HF hospitalization stays, each hospitalization was counted.
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Measured: 6 months
Length of hospital stay
Length of hospital stay was considered as the time from admission date until discharge for each HF hospitalization.
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Measured: 6 months
Number of HF hospitalizations per patient
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Measured: 6 months
Number of newly implanted devices
implanted devices: implantable cardioverter defibrillator (ICD), Cardiac resynchronization therapy (CRT), combination of ICD and CRT (CRT-D).
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Measured: 6 months
Number of valve interventions
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Measured: 6 months
Number of participants with medical history of selected comorbidities
To describe the HFrEF patient population with a recent decompensation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start3 Apr 2023
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004453
- Sponsor's protocol ID
- CLCZ696BDE06
- Acronym
- CONNECT
- Status last verified
- Nov 2025
- First submitted
- 17 Aug 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care in Heart Failure Units and Independent Centers Utilizing Established Quality Indicators
- ClinicalTrials.gov ID
- NCT06004453
- Acronym / sponsor ID
- CONNECT / CLCZ696BDE06
- Conditions
- Heart Failure
- Keywords
- Heart Failure, HFrEF, patient management, quality of care, quality indicators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 22 Aug 2023 (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.
This was a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (HFrEF) patient treatment and care following a decompensation event in different types of Heart Failure Unit (HFU) or non-HFU centers across Germany.
Detailed description
This study aimed to describe quality of care of HFrEF patients following a decompensation event in different center types (=settings) utilizing the quality indicators for the care and outcomes of adults with heart failure as specified by the Heart Failure Association in 2022.
No strict visit schedule was imposed on participants to avoid interference with routine clinical care. HFrEF patients were treated according to the local routine in terms of medication, visit frequency and types of assessments performed and only these data was collected as part of the study from patient files.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Heart Failure medicationsSupra-regional HFU Centers and HFU Focus Hospitals |
| Cohort B | – | Other: Heart Failure medicationsNon-HFU Hospitals |
| Cohort C | – | Other: Heart Failure medicationsHFU Residential Cardiologists |
| Cohort D | – | Other: Heart Failure medicationsNon-HFU Residential Cardiologists |
| Cohort E | – | Other: Heart Failure medicationsGeneral practitioners |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure with reduced ejection fraction patients with a recent decompensation event
Key inclusion criteria (4 listed)
- Patients who provide written informed consent to participate in the study
- Male or female patients ≥ 18 years of age
- Patients with diagnosis of heart failure with reduced ejection fraction (HFrEF) and HF treatment according to the summaries of product characteristics (SmPCs)
- Decompensation event up to three months prior to inclusion
Key exclusion criteria (3 listed)
- Simultaneous or planned participation in an interventional research study
- Participation in this study at another site e.g. in a HFU network
- Patients incapable of understanding and signing the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Failure medicationsThere was no treatment allocation. Patients were allocated to the respective cohort based on the treating physician enrolling them in the study. Patients were treated according to the local prescribing information and routine medical practice. | Other | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint
Time frame: 6 months
Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based QI composite endpoint defined by the number of times each of secondary endpoints has been accomplished divided by chances to accomplish them as average per center type. To describe the quality of Heart Failure (HF) patient care in Heart Failure Unit (HFU) and non-HFU centers utilizing QIs as suggested by the 2021 European Society of Cardiology HF guideline.
26 secondary outcomes
Proportion of sites with a dedicated multidisciplinary team to manage patients with HF
Time frame: Baseline
Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care.
Time frame: Baseline
(A) Proportion of patients with HF who have a documentation of their HF clinical type
Time frame: Baseline
(B) Proportion of patients with a documentation of their electrocardiogram findings
Time frame: 6 months
(C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation)
Time frame: 3 months
(D) Proportion of patients who have their blood tests documented
Time frame: 3 months
(E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program
Time frame: 6 months
(F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge
Time frame: 4 weeks
(G) Proportion of patients treated with beta-blocker bisoprolol, carvedilol, sustained-release metoprolol succinate, or nebivolol in the absence of any contraindications as defined by Aktaa et al 2022
Time frame: 6 months
(H) Proportion of patients treated with an Angiotensin-converting enzymes (ACE) inhibitor, Angiotensin receptor blocker (ARB) or Angiotensin receptor-neprilysin inhibitor (ARNI) in the absence of any contraindications
Time frame: 6 months
(I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications
Time frame: 6 months
(J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications
Time frame: 6 months
Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment
Time frame: 6 months
Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention
Time frame: 6 months
Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together
Time frame: 6 months
Percentage of days covered with all four treatment classes
Time frame: 6 months
(K) Proportion of symptomatic patients with HFrEF in sinus rhythm with a QRS duration ≥150ms and left bundle branch block QRS morphology and with LVEF ≤35% despite ≥3 months optimal medical therapy who are offered cardiac resynchronization therapy
Time frame: 6 months
(L) Proportion of symptomatic patients with HF, LVEF ≤35% despite ≥3 months of optimal medical therapy, and ischemic heart disease (IHD) who are offered primary prevention implantable cardioverter defibrillator
Time frame: 6 months
Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool
Time frame: 6 months
Number of patients who are eligible for and have accomplished secondary endpoint g-j divided by the number of patients who are eligible for g-j
Time frame: 6 months
Number of HF hospitalizations, stratified by bed type
Time frame: 6 months
Length of hospital stay
Time frame: 6 months
Number of HF hospitalizations per patient
Time frame: 6 months
Number of newly implanted devices
Time frame: 6 months
Number of valve interventions
Time frame: 6 months
Number of participants with medical history of selected comorbidities
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
94 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, run by Novartis Pharmaceuticals at 94 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 4 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: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.