Phase 2 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 aged 18 or older at the time of signing the consent form, of any gender
• People who have been admitted to hospital for heart failure within the 72 hours before being enrolled in the trial
• People who, at the time of assessment, have heart failure symptoms (such as breathlessness during activity, breathlessness at night, or needing to sit upright to breathe) AND at least one sign of fluid build-up in the body (such as crackling sounds in the lungs, swelling in the legs, or fluid in the lungs confirmed by a chest scan or X-ray)
• People whose blood test results show elevated heart failure markers (specific proteins called NT-proBNP or BNP) above certain levels within 12 hours before enrolment — with slightly different thresholds for people who also have an irregular heart rhythm called atrial fibrillation (confirm with trial site)
• People whose fluid retention symptoms have not responded well enough to standard water tablet (diuretic) treatment given in the 12 hours before enrolment

Who may not be able to join:

• People who have had a heart attack, stroke, mini-stroke, or serious abnormal heart rhythms within the past month, or who have had major surgery or serious injury within the past month
• People who have had certain heart procedures (such as stenting, bypass surgery, valve repair or replacement, carotid or limb artery procedures, use of a mechanical heart support device, or a heart transplant) within the past month, or who have these procedures planned during the study period — or people with severe heart or brain artery disease that has not been treated and could cause a serious event during hospitalisation
• People whose fluid build-up is judged by the trial doctor to be mainly caused by a non-heart condition, such as a severe lung disease flare-up, severe anaemia, advanced liver disease, or kidney protein-loss disease
• People whose current hospital admission is judged to be due to a heart failure cause that first requires treating an underlying condition — such as blocked heart arteries needing a procedure, active heart muscle inflammation, constrictive heart sac disease, fluid around the heart, complex heart structural problems present from birth, or severe untreated valve disease that could cause a serious event during hospitalisation
• People previously diagnosed with hypertrophic cardiomyopathy who are still in the hypertrophic phase, or people with a condition called amyloid cardiomyopathy
• People who are using a mechanical heart assist device at the time of assessment
• People who, at the time of assessment, have low blood volume or poor circulation to the body's tissues and are judged to need medicines to raise blood pressure, strengthen heart pumping, or receive fluid resuscitation
• People who have no urine output at the time of assessment, or who have difficulty urinating due to a blockage, stones, or a tumour in the urinary tract
• People who are unable to sense thirst, or who have any reason that makes it difficult to drink fluids
• People who are unable to complete weight measurements or urine collection during the trial
• People who have reduced consciousness at the time of assessment, or who have a condition causing brain dysfunction related to liver disease (either currently or in the past)
• People who have had a cancer of any type within the past 5 years that requires ongoing treatment such as chemotherapy, radiation, hormone therapy, or targeted drug therapy
• People with a history of drug or substance misuse within the past year
• People with a body mass index (a measure of body weight relative to height) below 18.5
• People with low blood pressure symptoms and/or a systolic (top number) blood pressure reading below 90 mmHg
• People with significantly reduced kidney function below a specific measured threshold, or who are currently having or are planned to have kidney dialysis or ultrafiltration treatment (confirm with trial site for exact values)
• People with significantly elevated liver enzyme levels on blood tests, unless the trial doctor judges this to be caused by the heart failure itself
• People with blood sodium levels that are too high (above the normal upper limit) or too low (below 125 mmol/L)
• People with blood potassium levels above the normal upper limit
• People with a known or suspected allergy to any of the study drugs being tested in this trial
• People who have taken part in another clinical drug or device trial within the past 3 months (or who are still within a specified washout period from a previous trial drug)
• People who currently require blood transfusions
• People who, due to a mental health condition, speech difficulty, or other reason, are unable to fully understand or participate in the trial, or cannot fully understand the possible side effects
• Women who are pregnant or breastfeeding, or people of childbearing potential who are unwilling to use the contraception methods required by the trial during the study and for one week after the last dose
• People who, in the trial doctor's judgement, have any other medical, psychological, social, or practical condition that could affect their safety or interfere with the trial results

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