Phase 3 Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a blood marker of inflammation called hs-CRP at a level of 2 mg/L or higher, measured at the first screening visit.
• People who meet at least one of the following heart-related blood marker conditions: a heart stress marker called NT-proBNP at 300 pg/mL or higher (or 600 pg/mL or higher for those with an ongoing irregular heart rhythm called atrial fibrillation or flutter), measured on the same day as a heart tracing (ECG) at the first screening visit; OR a hospital stay or urgent unplanned visit in the past 9 months for worsening heart failure that needed intravenous water tablets, combined with an NT-proBNP level of 200 pg/mL or higher (or 600 pg/mL or higher if atrial fibrillation or flutter is present).
• People who have been diagnosed with heart failure classified as moderate to severe (known as NYHA Class II, III, or IV).
• People whose heart pumping function, measured by an ultrasound of the heart (echocardiogram) within the past 12 months, shows the heart pumping more than 40% of its capacity, with no recent events suggesting the heart has gotten worse since that measurement.
• People whose heart ultrasound within the past 12 months shows at least one sign of structural or functional changes to the heart, such as an enlarged left upper chamber, thickened heart walls, increased heart muscle mass, or abnormal measurements of how the heart fills with blood (confirm specific measurements with trial site).
• People who have had no heart failure hospitalisations or urgent heart failure visits between their first and second trial visits.

Who may not be able to join:

• People who have had a heart attack, stroke, unstable chest pain, a mini-stroke, or a heart failure hospitalisation within the 30 days before the first screening visit.
• People with a very high systolic blood pressure (the top number) of 180 mmHg or above at screening, or between 160–179 mmHg while not already taking three or more blood pressure medications (the trial site may allow a retest within the visit window).
• People whose heart rate on the ECG at screening is above 110 or below 40 beats per minute (the trial site may allow a retest within the visit window).
• People who have a planned procedure to open up blood vessels in the heart, neck, or legs during the screening period (a planned heart imaging scan called a coronary angiogram is not excluded).
• People who have a planned procedure to fit a heart device or treat an irregular heart rhythm during the screening period.
• People who have had major heart surgery, non-heart surgery, or a major keyhole procedure within 60 days before the second trial visit, or who have such a procedure planned at that time.
• People whose heart failure is caused by certain specific heart conditions, such as a protein build-up in the heart (amyloid), inflammatory heart muscle disease (myocarditis), a genetic thickening of the heart muscle causing obstruction, or uncorrected significant heart valve disease, among others (confirm full list with trial site).
• People with primary high blood pressure in the lungs, long-term blood clots in the lungs, or severe lung disease including COPD.
• People whose heart failure symptoms may be explained by another condition, such as anaemia or an underactive thyroid, as judged by the treating doctor.
• People who show signs of, or are suspected to have, an active infection at the time of screening, as assessed by the treating doctor.

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