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:

• Adults aged 18 to 80 years old at the time of signing the consent form
• People who have been diagnosed with both coronary heart disease and chronic heart failure
• People whose heart failure has been assessed as matching a Traditional Chinese Medicine (TCM) pattern described as "Qi deficiency and blood stasis" (confirm with trial site)
• People whose heart failure symptoms fall into Class II or Class III on a standard heart failure severity scale, meaning symptoms appear during moderate or minimal physical activity
• People whose heart is pumping out less than 45% of its blood volume with each beat, as measured by a specific ultrasound method
• People who have been on a stable, unchanged heart failure medication plan for at least 2 weeks before joining the trial, with no intravenous medications given in that same 2-week period
• People who are willing to take part voluntarily, sign a consent form, and are able to follow the trial procedures throughout

Who may not be able to join:

• People whose heart failure is caused by certain other heart conditions, such as heart valve problems, a genetic heart muscle disorder, a heart-lining infection, a protein build-up disease in the heart, a stiff covering around the heart, or fluid around the heart
• People whose heart failure is caused by conditions outside the heart, such as a serious infection, an autoimmune disease, cancer that has spread to the heart, lung disease affecting the heart, high blood pressure in the lungs, or serious kidney or liver disease
• People whose heart failure is caused by damage from toxic substances, including certain cancer treatments or long-term heavy alcohol use
• People who had a heart attack, a procedure to open blocked heart arteries, a heart device implanted, or a stroke or mini-stroke within the 3 months before starting the trial
• People who are planning to have heart surgery, a procedure to open blocked arteries, or a heart device implanted during the trial period
• People who have a severe, ongoing, or uncontrolled illness affecting any major body system, including cancer
• People with blood pressure that remains too high (top number 160 or above, or bottom number 100 or above) despite treatment, or blood pressure that is too low (top number below 80 or bottom number below 50)
• People with serious heart rhythm problems, such as a dangerously fast heart rhythm or certain types of heart electrical blockages, who do not have a pacemaker
• People with liver enzyme levels more than twice the normal range, or kidney function markers more than 1.5 times the normal range
• People with a long-term blood sugar control reading (HbA1c) of 9.0% or higher
• People with a low red blood cell level (haemoglobin below 90 g/L)
• People with a high blood potassium level (above 5.5 mmol/L)
• People who need blood-thinning medication but whose dose has not been stable for at least 1 month, or whose blood-thinning level (INR) is above 3.0
• People who need anti-clotting medication but whose dose has not been stable for at least 1 month and whose platelet count is below the normal range
• People who are allergic to the study drug (Qishen YiQi Dripping Pills) or any of its herbal ingredients (Astragalus, Salvia, Panax notoginseng, or Dalbergia), or to other Chinese medicines with the same ingredients or functions
• People who have taken certain medications that affect exercise capacity (such as trimetazidine, ranolazine, coenzyme Q10, levocarnitine, or androgens), or similar Chinese medicine preparations, within the 2 weeks before joining
• People who are unable to safely complete a 6-minute walking test, or for whom the test is medically not recommended
• People who have taken part in another interventional drug trial within 1 month before the screening visit
• People who are pregnant or breastfeeding, planning a pregnancy, or unable to use effective contraception from screening until 1 month after the last dose
• People who the trial doctors consider unsuitable for any other reason, including concerns about their ability to follow the trial requirements or uncontrollable risks to their safety

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