CRT-P or CRT-D in Dilated Cardiomyopathy

NCT04139460 | Unknown DMC

• 1 other identifier: University Hospital Olomouc
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 1

Brief Summary

The ICD-Reality study is a non-commercial, investigator-led, multicenter, prospective, randomized, controlled trial. We aim to determine the effect of CRT-D or CRT-P implantation in non-ischemic cardiomyopathy and heart failure patients. The reason why we initiated this trial is the lack of evidence-based treatment for the significant number of these patients. In these patients, 5-year mortality remains as high as 20% despite recent therapeutic advances. Based on currently available evidence, because of a significant decrease in mortality due to modern pharmacotherapy, it is not certain which of these patients should receive a CRT-P and who should receive a CRT-D. No dedicated and adequately powered trial has addressed this important question. We hypothesize that patients with symptomatic HF, LVEF ≤35%, without left ventricular mid-wall fibrosis on LGE-CMR, will not benefit from CRT-D implantation compared with CRT-P only implantation. If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures. We aim to enroll 600 patients in the trial. 924 patients are needed to be screened for these 600 patients to be randomized. Patients with non-ischemic HF visiting an out-patient department and possibly eligible for the trial will have their pharmacotherapy optimized. Patients with a significant amount of fibrosis will be excluded from the study and treated according to local practice with an emphasis on ICD implantation to prevent SCD. After fulfilling all eligibility criteria, including maximally tolerated pharmacotherapy, subjects will be randomized by the physicians who enrolled them in a 1:1 ratio to receive CRT-D or CRT-P implantation. All patients will be followed-up for at least 3 years after the implantation.

Conditions

Cardiomyopathy, Dilated, 3B

Keywords

Non-ischemic cardiomyopathy; Heart failure; Implantable cardioverter-defibrillator; Cardiac resynchronization therapy; Magnetic resonance imaging; Late gadolinium enhancement

Outcome Measures

Primary Outcomes (3)

• Re-hospitalization for heart failure

  Event rate

  0-3 years after device implantation

• Ventricular tachycardia

  Event rate, sustained ventricular tachycardia documentation during follow-up

  0-3 years after device implantation

• Major adverse cardiac events (MACE)

  Event rate of MACE, defined as a composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

  0-3 years after device implantation

Secondary Outcomes (6)

• Sudden cardiac death

  0-3 years after device implantation

• Cardiovascular death

  0-3 years after device implantation

• Resuscitated cardiac arrest or sustained ventricular tachycardia

  0-3 years after device implantation

• Device-related complications

  0-3 years after device implantation

• The impact in terms of overall quality of life by the SF-36 Questionnaire

  3 years after device implantation

Study Arms (2)

CRT-D

ACTIVE COMPARATOR

Implantation of cardiac resynchronization therapy with a defibrillator (CRT-D)

Device: CRT-D

CRT-P

ACTIVE COMPARATOR

Implantation of cardiac resynchronization therapy pacemaker (CRT-P)

Device: CRT-P

Interventions

CRT-D DEVICE

After randomization, devices will be implanted as soon as possible (within 2 weeks). The ICD will be programmed with anti-tachycardia pacing and shock therapy as per common praxis.

CRT-D

CRT-P DEVICE

After randomization, devices will be implanted as soon as possible (within 2 weeks).

CRT-P

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age at the time of screening
• Documented non-ischemic HF with an LVEF ≤ 35
• QRS≥130ms; NYHA class II-IV
• Signed written informed consent
• NT-proBNP above 200 pg/ml

You may not qualify if:

• Uncorrected congenital heart disease or valve obstruction
• obstructive cardiomyopathy
• active myocarditis
• constrictive pericarditis
• untreated hypothyroidism or hyperthyroidism
• adrenal insufficiency
• active vasculitis due to collagen vascular disease
• Presence on the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent)
• Recipient of any major organ transplant (e.g., lung, liver, heart)
• Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomization or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with a life expectancy of \> 2.5 years in the opinion of the investigator)
• Known to be human immunodeficiency virus positive with an expected survival of less than 5 years due to HIV
• Chronic kidney disease with glomerular filtration rate \<30 ml/min
• Chronic dialysis treatment
• Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report
• Any condition (e.g., psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study

Sponsors & Collaborators

• University Hospital Olomouc: lead

Study Sites (1)

University hospital Olomouc

Olomouc, Česká Republika, 77900, Czechia

Location

Related Publications (24)

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MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Heart Failure

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Cardiovascular Diseases

Study Officials

• Milos Taborsky, MD, PhD

  University Hospital Olomouc

  STUDY DIRECTOR

Central Study Contacts

Tomas Skala, MD, PhD

CONTACT

+420 588 44 3212; tomasskala@gmail.com

Irena Opavska, Mgr.

CONTACT

+420 588 44 3201; irena.opavska@fnol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Trial participants will be blinded to the device type for the whole duration of the trial. The randomizing and implanting physicians will not be blinded to the type of the device. These physicians will not take care in the subsequent patients' follow-up and sign a declaration of confidentiality. The same will be true for the physicians / technicians attending to the device interrogation during follow-up visits. The device type will be hidden and physicians will sign a declaration of confidentiality. The patients' documentation will not reveal the device type. A maximum effort will be done to hide the type of the implanted device. The implantation will be intramuscular and the device interrogation follow-up visits will not reveal the device type. The physicians attending the follow-up visits and entering all patients' data into web-based CRF will be blinded to the implanted device type. The outcomes assessors will also be blinded to the implanted device type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective, randomized, interventional parallel-design trial

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 25, 2019
• Study Start: June 1, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available 6 months after the study results are published.
• Access Criteria: The requests to gain access to IPD will be reviewed by National principal investigator.

Locations

CZ (1)