Phase 3 Heart Disease Trial, Recruiting NCT07038356 Sponsor: Christian Schulze Condition: Heart Disease
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Phase 3 Heart Disease Trial, Recruiting

NCT07038356
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older who have been diagnosed with a sudden worsening of heart failure, based on a doctor's assessment, and are already taking a type of medication called an SGLT2 inhibitor
  • People with elevated levels of certain heart stress markers in their blood (BNP or NTproBNP) above specific levels measured by a blood test
  • People who have agreed to take part and signed a written consent form
  • Women who could become pregnant must have a negative pregnancy test and be using a highly effective form of contraception

Who may not be able to join:

  • People with Type 1 diabetes
  • People with severe long-term kidney disease (where kidney function is very low) or who are already on regular dialysis
  • People experiencing a sudden kidney injury that requires dialysis treatment
  • People who are known to have had a bad reaction or intolerance to the medication empagliflozin
  • People whose acute heart failure does not show signs of fluid build-up in the body (sometimes called a "dry" presentation)
  • People who need or are likely to need a heart scan involving dye injected into the bloodstream (coronary angiography or contrast media)
  • People who need a specialised kidney filtering treatment (hemofiltration) or any similar machine-based therapy
  • People who have planned surgery coming up
  • People who have taken part in this trial before, or who have been in another clinical trial within the last 4 weeks
  • People whose heart failure worsening is caused by a condition needing urgent treatment, such as a heart attack, severe unstable heart rhythm problems, a mechanical heart problem, or a sudden blood clot in the lungs
  • People who are unable to understand the study or provide written consent
  • People with obvious uncontrolled substance abuse
  • People who are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Christian Schulze
Registry
ClinicalTrials.gov
Start date
8 December 2025
Est. completion
30 April 2026

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Four-step hierarchical composite primary endpoint; win ratio based on the following parameters (day 90): time to all-cause death, number of heart failure events per patient, time to first heart failure event, eGFR decrease from baseline to day 90

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov