Development of an Evidenced-Based Tool for Prediction of Sudden Death in Patients With Non-Ischemic Cardiomyopathy

NCT02657967 | Completed

• 2 other identifiers: WUH 1430518-01681
• Study Type: observational
• Target: 57
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Non-ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• All cause death

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-ischemic cardiomyopathy and an ejection fraction of ≤40%.

You may qualify if:

• 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.
• LVEF ≤ 40%. (Based on transthoracic echocardiography \[Simpson´s Rule\])
• NYHA functional class I-IV
• Patients aged 18 to 85, both genders and of all races and ethnicities.
• Patients diagnosed with peripartum cardiomyopathy (PPCM) may be included as long as they are enrolled within six months of initiation of cardiac symptoms.
• Patients must be competent to give informed consent.

You may not qualify if:

• Significant coronary artery disease \> 75% luminal stenosis in at least 1 epicardial vessel, or history of myocardial infarction1 or coronary revascularization.
• Congenital heart disease.
• Infiltrative cardiomyopathy (amyloid, sarcoidosis, glycogen storage disease or hemochromatosis).
• 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.
• Absolute contraindications to undergo CMR (Renal failure with glomerular filtration rate(GFR)\<30% or ICD/PPM).
• Unwilling or unable to provide informed consent.
• 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.
• 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.
• Patients who are post cardiac transplant.
• Pregnancy.
• Subjects who are asymptomatic, but are diagnosed with a cardiomyopathy of unknown duration during screening for known familial disease are excluded
• Patients who are enrolled in other trials with a treatment arm (Patients enrolled in diagnostic trials can be included).
• 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.
• Patients on anti-arrhythmics or immunosuppressant drugs.
• Tachyarrhythmia/Premature Ventricular Contraction (PVC) induced cardiomyopathy which normalizes within 3 months after beginning of treatment of tachyarrhythmia/PVCs.

Sponsors & Collaborators

• NYU Langone Health: lead
• Mayo Clinic: collaborator
• University Health Network, Toronto: collaborator

Study Sites (3)

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University Health Network Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood specimens obtained with subject permission, will be retained for the purpose of future genetic research.

Study Officials

• Juan Gaztanaga, MD

  NYU Langone Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: January 18, 2016
• Study Start: May 1, 2015
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)