Pulmonary Hypertension 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 to 85 years old
• People who have been diagnosed with chronic heart failure caused by left-sided heart disease for at least 6 months, regardless of how well their heart pumps, and who still have symptoms despite receiving the maximum recommended heart failure treatments and any appropriate cardiac devices
• People whose condition has been stable for at least the past month — meaning no hospital stays for heart failure, no major changes to standard heart failure medications, no heart device implants in the past 3 months, and no major treatment changes expected after the procedure
• People whose resting blood pressure is between 90 and 160 mmHg, and whose resting heart rate is between 50 and 100 beats per minute (or up to 110 beats per minute for those with atrial fibrillation)
• People whose heart ultrasound shows a certain level of elevated pressure in the pulmonary artery (confirm with trial site)
• People with New York Heart Association heart failure symptoms rated as Class II, III, or IVa — meaning symptoms range from appearing with moderate activity up to symptoms at rest, as long as the person can still walk around and does not need continuous intravenous medications
• People who can walk between 100 and 450 metres in a 6-minute walk test, where the limitation is breathlessness or tiredness rather than joint or other non-heart-related problems
• People with a specific blood marker of heart stress (NT-proBNP) at or above a certain level depending on how well their heart pumps (confirm with trial site for exact values)
• People who are willing and able to follow all parts of the study, including taking medications as directed and attending all follow-up visits and tests
• People, or their legal representative, who have signed an ethics-approved consent form before the study begins

Who may not be able to join:

• People whose life expectancy is less than one year due to a condition unrelated to the heart
• People with certain specific types of heart muscle disease, including a thickened heart muscle causing blockage or valve movement problems, disease of the sac around the heart, or conditions where abnormal material builds up in the heart muscle (such as amyloidosis)
• People with severe narrowing or leaking of any heart valve, moderate or severe narrowing of the aortic valve, or any narrowing of the pulmonic valve
• People with symptomatic narrowing of the carotid arteries in the neck, or who have had a mini-stroke or stroke in the past 30 days, or any previous stroke that left a significant permanent disability
• People who have ever had bleeding inside the skull, or who have a known condition in the brain that increases the risk of bleeding (such as a tumour, abnormal blood vessel connection, or aneurysm)
• People with a known condition that causes problems with blood clotting, or who would refuse a blood transfusion if needed
• People who are allergic to heparin (a blood-thinning medication), unless alternative blood-thinning medications can be used instead
• People with a life-threatening allergy to contrast dye used in imaging that cannot be safely managed with pre-treatment, or anyone who has previously had a severe allergic reaction to contrast dye
• People with congenital (present from birth) heart defects, other than mitral valve prolapse or a small hole between the upper chambers of the heart (PFO)
• People who have had heart bypass surgery or a procedure to open blocked coronary arteries in the past 6 months, or for whom such a procedure is planned within 12 months after joining the trial
• People who have had a pacemaker lead or wire placed inside the heart in the past 3 months, or who have certain implanted heart monitoring or stimulation devices placed in the past 3 months, or for whom implantation of any such device is planned within 12 months after the procedure
• People who have had a procedure to treat atrial fibrillation (an irregular heart rhythm) in the past 6 months, or for whom such a procedure is planned within 12 months after joining
• People who have had heart valve surgery or a catheter-based valve procedure in the past 6 months, or for whom such a procedure is planned within 12 months after joining
• People who have had an implant placed in the tricuspid or pulmonic valves (rings placed to reshape a valve are allowed)
• People who have a filter implanted in the large vein that carries blood back to the heart from the lower body (inferior vena cava filter)
• People who have previously received a heart or heart-lung transplant, who are currently on a transplant waiting list, or for whom a mechanical heart pump (ventricular assist device) implant is expected within 6 months after joining
• People who have a blood clot inside the heart, as seen on a heart ultrasound
• People who have a significant fluid collection around the heart (10 mm or more) on a heart ultrasound
• People whose elevated lung blood pressure is primarily caused by conditions other than the type related to left-sided heart failure (specifically, the trial targets a type called WHO Group 2 combined post-capillary pulmonary hypertension — confirm with trial site)
• People who have been treated with certain medications targeting pulmonary arterial hypertension (including a drug called sotatercept) in the past month, or for whom such treatment is planned after joining
• People who are expected to need any surgery (other than minor procedures done under local anaesthetic) within 6 months after joining
• People with severely reduced kidney function, including those on dialysis
• People with severely reduced liver function (classified as Child-Pugh Class C — confirm with trial site)
• People with a low platelet count (below 100 × 10⁹/L — confirm with trial site)
• People with a long-term inflammatory or other condition requiring ongoing use of steroid tablets or immune-suppressing medications
• People with an active infection currently being treated with antibiotic tablets or intravenous antibiotics
• People with a body mass index (BMI) above 45
• People with severe lung disease, defined by specific results across multiple breathing tests falling below certain thresholds, or people who require oxygen therapy when moving around or on a long-term basis (confirm with trial site for specific test values)
• People with known severe sleep apnea that is not being treated — note that people whose sleep apnea has been treated with a CPAP or BiPAP machine for at least 3 months are not excluded
• People who have had a blood clot in the lungs or legs in the past 6 months
• People who are pregnant, breastfeeding, or planning to become pregnant within one year; women who could become pregnant must have a negative pregnancy test within one week of joining
• People who are currently participating in another clinical trial of an unapproved drug or device that has not yet completed its main study goals
• People with severe physical wasting, extreme frailty, substance abuse, or any other condition that the trial investigators believe may prevent the person from completing all study requirements including follow-up visits
• People who, in the judgment of the investigator, are unable to give informed consent freely — including due to mental disability, age, personal circumstances, or being part of a group where there may be pressure or reduced freedom to decide independently (such as prisoners, people in emergency situations, or those in hierarchical relationships with the study team)

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