Non-ischemic Cardiomyopathy Clinical Trial
— NICMROfficial title:
Development of an Evidenced-Based Tool for Prediction of Sudden Death in Patients With Non-Ischemic Cardiomyopathy (NICM-Registry)
Verified date | May 2020 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This study is an observational study to determine predictors of sudden cardiac death or appropriate ICD therapy in patients with non-ischemic cardiomyopathy. Patients will be followed for 36 months for the occurrence of sudden cardiac death
Status | Completed |
Enrollment | 57 |
Est. completion date | October 24, 2019 |
Est. primary completion date | October 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network Toronto General Hospital | Toronto | Ontario |
United States | Montefiore Medical Center | Bronx | New York |
United States | NYU Winthrop Hospital | Mineola | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health | Mayo Clinic, University Health Network, Toronto |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sudden Cardiac Death or Appropriate ICD Shock Therapy or Anti-tachycardia Pacing or Resuscitated Sudden Cardiac Death | Sudden cardiac death is defined as patients who die suddenly and unexpectedly within 1 hour of cardiac symptoms in the absence of progressive cardiac deterioration, die unexpectedly in bed during sleep and/or die unexpectedly within 24 hours after last being seen alive. Appropriate ICD therapy is defined as Shock Therapy or Antitachycardia Pacing. |
3 years | |
Secondary | All cause death | 3 years |
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