Phase 1 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 21 or older but under 80 years of age.
• People who are willing and able to provide written consent to participate.
• People who have been diagnosed with long-term heart muscle weakness caused by a previous heart attack, confirmed by an imaging study showing blocked heart arteries and areas of the heart that are not moving properly.
• People who are scheduled to undergo a heart catheterization procedure within 5 to 10 weeks of their screening appointment.
• People who have been on the best available medical treatment for heart failure for a set period of time — including stable doses of specific heart medications (such as beta-blockers for at least 3 months, and certain blood pressure/heart failure medications for at least 1 month) (confirm with trial site).
• People whose heart is pumping at less than 40% of its normal capacity (known as a low ejection fraction).
• People who have experienced moderate to moderately severe heart failure symptoms (classified as Class II or III) at some point in the 6 months before baseline testing.
• People who have either been hospitalised in the past 6 months for their heart condition, or who have a specific heart stress marker in their blood above a certain level (confirm with trial site for exact values).
• People who already have an implanted device in their chest designed to correct dangerous heart rhythms (a defibrillator, sometimes called an AICD or ICD).

Who may not be able to join:

• People whose kidneys are not functioning well enough (below a certain filtration rate threshold) (confirm with trial site).
• People with a known severe allergy to the dye used in imaging procedures (radiographic contrast).
• People who have an artificial aortic heart valve or a device that constricts the heart.
• People who have a diagnosed narrowing of the main heart valve (aortic stenosis) at or below a certain severity level.
• People who have a diagnosed leaking of the main heart valve (aortic insufficiency) at a moderate to severe level.
• People who have a history of a serious, potentially life-threatening heart rhythm problem and do not have a working defibrillator or pacemaker in place, or who have an abnormal heart electrical reading (QTc interval above 550 ms) on their screening heart tracing.
• People whose implanted defibrillator has delivered a shock in the 60 days before enrolling.
• People who are eligible for, or require, a procedure to open or bypass blocked heart arteries (coronary revascularisation).
• People with significantly abnormal blood counts, such as very low red blood cells, white blood cells, or platelets, without another known cause.
• People with significant liver problems, shown by liver enzyme levels more than three times the normal upper limit.
• People with a blood clotting problem (unless it is caused by a reversible medication such as warfarin/Coumadin, which may be temporarily stopped before the procedure under medical supervision — those who cannot stop this medication would not be eligible).
• People with known allergies to penicillin or streptomycin.
• People who have previously received an organ transplant.
• People with a history of rejecting a transplanted organ or cells.
• People who have had a cancer diagnosis within the past 5 years, except for certain skin cancers or cervical cancer that have been fully treated and cured.
• People with a non-heart-related condition that is expected to limit their life expectancy to less than one year.
• People who are currently taking long-term immune-suppressing medications, such as steroids or certain anti-inflammatory drugs (TNFα antagonists).
• People who test positive for HIV, hepatitis B, or active hepatitis C.
• People who are currently enrolled in, or have participated in, another experimental treatment or device trial within the past 30 days.
• Female patients who are pregnant, breastfeeding, or who are capable of becoming pregnant but are not using effective contraception.
• People who have tested positive for COVID-19 (SARS-CoV-2) within the past 30 days.

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