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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Germany

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 groups in NCT06004453
Study groupRoleWhat they receive
Cohort ASupra-regional HFU Centers and HFU Focus Hospitals
Receives: Other: Heart Failure medications
Cohort BNon-HFU Hospitals
Receives: Other: Heart Failure medications
Cohort CHFU Residential Cardiologists
Receives: Other: Heart Failure medications
Cohort DNon-HFU Residential Cardiologists
Receives: Other: Heart Failure medications
Cohort EGeneral practitioners
Receives: Other: Heart Failure medications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Proportion of sites with a dedicated multidisciplinary team to manage patients with HF

    To describe the structural framework of the participating centers.

    Measured: Baseline

  2. 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

  3. (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

  4. (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

  5. (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

  6. (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

  7. (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

  8. (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

  9. (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

  10. (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

  11. (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

  12. (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

  13. 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

  14. 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

  15. 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

  16. 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

  17. (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

  18. (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

  19. 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

  20. 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

  21. 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

  22. 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

  23. Number of HF hospitalizations per patient

    To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.

    Measured: 6 months

  24. 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

  25. Number of valve interventions

    To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.

    Measured: 6 months

  26. 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.

  1. First posted22 Aug 2023
  2. Study start3 Apr 2023
  3. Primary completion17 Jan 2025
  4. Study completion17 Jan 2025

Resources

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)
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

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.

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