Phase 3 Heart Disease Trial, Recruiting NCT05508035 Sponsor: John Paul II Hospital, Krakow Condition: Heart Disease
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Phase 3 Heart Disease Trial, Recruiting

NCT05508035
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:

  • People aged 18 or older.
  • People who have heart failure caused by reduced blood flow to the heart (ischemic origin), with symptoms classified as moderate to severe (NYHA Class II to IV).
  • People whose heart's pumping strength (left ventricular ejection fraction) was measured between 40–49% at the screening visit.
  • People with a specific heart protein marker (NT-proBNP) level of 125 pg/ml or higher in their blood.
  • People who have signs of structural or functional changes to the left side of the heart.
  • People who are already taking the recommended heart failure medications (a type of blood pressure tablet called an ACEI or ARB, and a beta-blocker), unless those medications are not suitable for them.
  • People who have provided written agreement to take part before any study procedures begin.

Who may not be able to join:

  • People with a known allergy or bad reaction to any of the study drugs, or to medications in the same drug families (ACEIs, ARBs, or neprilysin inhibitors).
  • People who have previously been unable to tolerate the recommended doses of ACEI or ARB medications.
  • People with a known history of a condition called angioedema (a type of serious swelling reaction).
  • People who need to take both an ACEI and an ARB medication at the same time.
  • People who had a sudden worsening of heart failure in the 6 weeks before the screening visit.
  • People whose blood pressure was too low (systolic below 100 mmHg) at the screening visit.
  • People who are currently taking, or have previously taken, a medication called sacubitril/valsartan.
  • People whose kidneys are not working well enough, based on a specific measurement taken at the screening visit (confirm with trial site).
  • People with potassium levels in their blood that are too high (above 5.2 mmol/L) at the screening visit.
  • People who had a heart attack or a planned procedure to open blocked heart arteries within the 6 weeks before screening.
  • People who had a stroke, a mini-stroke (TIA), a neck artery procedure, heart surgery, or other major heart-related surgery within the 3 months before screening.
  • People who have a pacemaker, defibrillator, or heart resynchronisation device that is not compatible with MRI scans.
  • People with a permanent (fixed) form of an irregular heart rhythm called atrial fibrillation.

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 12 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.

Contact this trial

Phone: +48 12 6142218

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
John Paul II Hospital, Krakow
Registry
ClinicalTrials.gov
Start date
13 July 2023
Est. completion
1 March 2027

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

Change in left ventricular end-systolic volume

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: 12 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