Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT02657967
Eligibility Criteria:
Inclusion Criteria:
1. Newly diagnosed NICM defined as patients whose initial signs or symptoms of cardiomyopathy do not pre-date the time of enrollment for the study by more than six months.
2. LVEF ≤ 40%. (Based on transthoracic echocardiography \[Simpson´s Rule\])
3. NYHA functional class I-IV
4. Patients aged 18 to 85, both genders and of all races and ethnicities.
5. Patients diagnosed with peripartum cardiomyopathy (PPCM) may be included as long as they are enrolled within six months of initiation of cardiac symptoms.
6. Patients must be competent to give informed consent.
Exclusion Criteria:
1. Significant coronary artery disease \> 75% luminal stenosis in at least 1 epicardial vessel, or history of myocardial infarction1 or coronary revascularization.
2. Congenital heart disease.
3. Infiltrative cardiomyopathy (amyloid, sarcoidosis, glycogen storage disease or hemochromatosis).
4. Patients whose heart failure is felt to be secondary to primary valvular disease ( ≥ moderate/severe mitral regurgitation), uncorrected thyroid disease, uncontrolled hypertension despite medical therapy, obstructive or hypertrophic cardiomyopathy, pericardial disease or a systemic illness.
5. Absolute contraindications to undergo CMR (Renal failure with glomerular filtration rate(GFR)\<30% or ICD/PPM).
6. Unwilling or unable to provide informed consent.
7. Patients with other life threatening diseases such as malignancy which would likely decrease their life expectancy over the next three years. Any history of malignancy treated with either chest radiation or chemotherapy.
8. Past or present history of alcoholism, or in whose current alcohol consumption exceeds an average of three drinks per day. A past history of cocaine or IV drug abuse as a possible explanation for their cardiomyopathy as well as substance abuse of prescription pain relievers or any illicit drug that may hinder the participant's ability to complete study follow-up.
9. Patients who are post cardiac transplant.
10. Pregnancy.
11. Subjects who are asymptomatic, but are diagnosed with a cardiomyopathy of unknown duration during screening for known familial disease are excluded
12. Patients who are enrolled in other trials with a treatment arm (Patients enrolled in diagnostic trials can be included).
13. Difficulty to attend the follow-up schedule due to a history of medical noncompliance, living a distance from the study center, or anticipated nonresidence in the area for the length of time required for follow-up.
14. Patients on anti-arrhythmics or immunosuppressant drugs.
15. Tachyarrhythmia/Premature Ventricular Contraction (PVC) induced cardiomyopathy which normalizes within 3 months after beginning of treatment of tachyarrhythmia/PVCs.
16. The following patients are excluded for medical reasons: Patients with evidence of chronic liver disease (total bilirubin \>3.0mg%) or chronic renal disease (creatinine \> or equal to 2.5mg%) are excluded from the study. Subjects who present with an acute worsening of renal function or liver function tests in the setting of worsening heart failure can be enrolled if GFR \>30% at the time of CMR.
17. Evidence of ongoing bacteremia or sepsis. Patient with a febrile illness felt to be secondary to myocarditis (even with a non-diagnostic biopsy).
18. Patients who have had a myocardial biopsy that reveals evidence of myocarditis as defined by Dallas criteria or cardiac MRI evidence of myocarditis by Louise criteria are excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02657967
Study Brief:
Protocol Section:
NCT02657967