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 chronic heart failure and have been taking water pills (diuretics) — either regularly or occasionally — for more than 30 days to manage their symptoms.
• People whose heart failure symptoms fall into a moderate-to-severe category (known as NYHA Class II with recent worsening, Class III, or ambulatory Class IV), which may include shortness of breath during mild activity, when lying flat, or at night.
• People who meet at least one of the following: a hospital stay in the past 12 months primarily for heart failure treated with intravenous (IV) water pills; OR certain blood test results (BNP or NT-proBNP levels) above specified levels in the past 6 months; OR results from a specialised heart pressure test (right heart catheterisation) showing elevated pressure readings.
• People whose heart failure treatment has been stable — meaning no major medication changes — for at least 30 days before the screening visit, and is expected to stay stable for at least 6 months.
• People who have not started certain weight-loss or diabetes medications (GLP-1 or GIP agonists) in the past 6 months and do not plan to start them within 6 months of joining the trial.
• People whose heart pumping function (left ventricular ejection fraction) is measured at 50% or above on an ultrasound of the heart done within the past 6 months.
• People aged 40 years or older.
• People who are willing and able to give informed consent, follow the study procedures, and attend follow-up visits.

Who may not be able to join:

• People who have had a heart attack (Type I), a heart procedure through blood vessels (such as stenting), or heart bypass surgery within the past 3 months, or who currently need coronary artery treatment.
• People who have had a cardiac resynchronisation therapy (a type of pacemaker) device started within the past 3 months.
• People with advanced (Stage D) heart failure, those who cannot walk due to heart failure (non-ambulatory NYHA Class IV), those who have received continuous or intermittent IV drugs to support heart pumping (inotropes) in the past 6 months, those on the heart transplant waiting list, or those who have ever used a mechanical heart support device.
• People whose heart ultrasound shows a specific pattern of stiff heart function (E/A ratio above 2.0) indicating poor left heart compliance (confirm with trial site).
• People whose heart ultrasound shows significant weakness on the right side of the heart, based on specific measurements (TAPSE below 12 mm or FAC below 25%).
• People with a body mass index (BMI) above 45.
• People who walk less than 100 metres or more than 450 metres in a 6-minute walk test.
• People who were admitted to hospital for heart failure within 30 days before the planned procedure.
• People with a known history of, or who show signs of, a significant drop in blood pressure when standing up (orthostatic hypotension), or who are being treated with Midodrine for this condition.
• People who show a specific drop in pulse pressure when moving from lying down to standing, without a corresponding increase in heart rate (confirm with trial site).
• People with postural orthostatic tachycardia syndrome or preload insufficiency syndrome.
• People with a resting systolic blood pressure below 100 mmHg or above 170 mmHg despite appropriate treatment.
• People whose resting heart rate at screening is above 100 beats per minute, or who have a dangerous fast heart rhythm (ventricular tachycardia).
• People who have had a catheter ablation procedure for atrial fibrillation (an irregular heartbeat) within the past 6 months, or who plan to have one within the next 12 months.
• People whose heart pumping function (ejection fraction) was below 40% at any point in the past 3 years, unless that was a temporary drop linked to a short-term illness or event.
• People with significant heart valve problems, including more than mild narrowing of the mitral valve, more than moderate leaking of the mitral valve, more than moderate-to-severe leaking of the tricuspid valve, or more than moderate narrowing or leaking of the aortic valve.
• People with certain specific heart muscle or heart lining conditions, such as hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative conditions affecting the heart (such as haemochromatosis or sarcoidosis).
• People with a known history of significant liver cirrhosis.
• People who have had weight-loss (bariatric) surgery in the past.
• People who are on kidney dialysis, or whose kidney function test (eGFR) result is below 25 ml/min/1.73m².
• People whose blood oxygen level on room air is below 90%.
• People with serious chronic lung disease who require home oxygen continuously, who were hospitalised for a lung condition in the past 12 months, or who have severe COPD (GOLD Class III or worse).
• People currently taking part in another clinical trial involving an investigational drug or device that has not ended at least 30 days before the screening visit.
• People whose life expectancy is less than 12 months due to a condition unrelated to heart disease.
• People with any other condition or surgical history that, in the opinion of the trial doctors, could affect the study results or put the person at additional risk.
• People who are pregnant, breastfeeding, or planning to become pregnant within the next year.
• People whose right heart catheterisation results show a mean right atrial pressure above 20 mmHg at rest, a cardiac index below 2.0 L/min/m² at rest, or pulmonary vascular resistance above 4 Wood units.
• People whose blood vessel anatomy or any prior spinal surgery makes it impossible to safely pass the trial device to the target locations in the body during the procedure.

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