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Real-World heart failure drug study launches in germany

NCT ID NCT06336330

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study follows over 800 heart failure patients in Germany who are starting dapagliflozin, a drug recently approved for heart failure. Researchers will track how long patients stay on the drug, any side effects, and changes in symptoms and quality of life. The goal is to understand how the drug works outside of clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin
What this could lead to
If successful, this study could show how well dapagliflozin works for heart failure in everyday practice, helping doctors better manage the condition.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by other factors and may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

831 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who have received treatment with dapagliflozin for HF since 14-90 day before entering the study will be eligible for enrolment by either primary or secondary care healthcare professionals from outpatient settings. All treatment decisions (i.e., dose and duration of treatment) will be at the discretion of the patient's healthcare provider. Patients may have discontinued from dapagliflozin prior to enrolment onto the study, as long as their dapagliflozin initiation was ≥14 days and ≤90 days prior to enrolment onto the study. Data on other parameters may be obtained at the date of initiation of dapagliflozin by extracting this information retrospectively from medical charts. Patients will only be enrolled after they have given consent to participate in the study. It is at the discretion of the physician whether or not to initiate patients on treatment with dapagliflozin and enrol them in the study.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years as of study index date; the study index date is date of initiation of treatment with dapagliflozin * Patient received/receiving treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure (HF) and at timepoint of dapagliflozin initiation with: * preserved ejection fraction (HFpEF; EF≥50%) OR mildly reduced ejection fraction (HFmrEF; EF 41-49%) * OR reduced ejection fraction (HFrEF EF ≤40%) * Patient is enrolled within 14 to 90 days following initiation of dapagliflozin * Signed and dated informed consent prior to enrolment in the study Exclusion Criteria: * Patient should not be enrolled if he/she is less than 14 days or more than 90 days following initiation of dapagliflozin * Prior treatment with dapagliflozin or other SGLT2i treatment * Initiation of dapagliflozin outside of the local HF label * Diagnosis of Type 1 diabetes prior to enrolment * Current or planned participation in a clinical trial using an investigational medical product for treating HF * Patient is involved in the planning and/or conduction of the study * Hypersensitivity to dapagliflozin or to any of the excipients listed in the SmPC

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Heart diseases Heart failure

Contacts and locations

Locations

  • Research Site

    Aachen, 52062, Germany

  • Research Site

    Alsfeld, 36304, Germany

  • Research Site

    Bamberg, 96049, Germany

  • Research Site

    Bechhofen, 66894, Germany

  • Research Site

    Bergisch Gladbach, 51465, Germany

  • Research Site

    Berlin, 12489, Germany

  • Research Site

    Berlin, 12555, Germany

  • Research Site

    Brilon, 59929, Germany

  • Research Site

    Bruchsal, 76646, Germany

  • Research Site

    Chemnitz, 09113, Germany

  • Research Site

    Dinslaken, 46535, Germany

  • Research Site

    Erfurt, 99084, Germany

  • Research Site

    Erfurt, 99097, Germany

  • Research Site

    Essen, 45128, Germany

  • Research Site

    Frankenthal, 67227, Germany

  • Research Site

    Gera, 07551, Germany

  • Research Site

    Hamburg, 20095, Germany

  • Research Site

    Hamburg, 22087, Germany

  • Research Site

    Hamburg, 22459, Germany

  • Research Site

    Hoppegarten, 15366, Germany

  • Research Site

    Kaiserslautern, 67655, Germany

  • Research Site

    Kitzingen, 97318, Germany

  • Research Site

    Ludwigsburg, 71634, Germany

  • Research Site

    Ludwigshafen am Rhein, 67071, Germany

  • Research Site

    M Hldorf, 84453, Germany

  • Research Site

    Markkleeberg, 4416, Germany

  • Research Site

    Meiningen, 98617, Germany

  • Research Site

    Münster, 48149, Germany

  • Research Site

    Naumburg, 6618, Germany

  • Research Site

    Nuremberg, 90402, Germany

  • Research Site

    Oschersleben, 39387, Germany

  • Research Site

    Papenburg, 26871, Germany

  • Research Site

    Pirna, 01796, Germany

  • Research Site

    Potsdam, 14471, Germany

  • Research Site

    Querfurt, 06268, Germany

  • Research Site

    Ratingen, 40882, Germany

  • Research Site

    Rostock, 18059, Germany

  • Research Site

    Schleswig, 24837, Germany

  • Research Site

    Schwandorf in Bayern, 92421, Germany

  • Research Site

    Schwäbisch Hall, 74523, Germany

  • Research Site

    Siegen, 57072, Germany

  • Research Site

    Steinfurt, 48565, Germany

  • Research Site

    Stollberg, 09366, Germany

  • Research Site

    Straubing, 94315, Germany

  • Research Site

    Stuttgart, 70178, Germany

  • Research Site

    Ulm, 89073, Germany

  • Research Site

    Wermsdorf, 04779, Germany

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