NCT04505007Completed
Guideline-Directed Medical Therapy in Patients After Implantation of Implantable Cardioverter Defibrillators to Improve Long-Term Outcomes
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
Guideline-directed medical therapy (GDMT) and the mortality benefit it provides in the heart failure with reduced ejection fraction (HFrEF) population are well-established by multiple professional society guidelines. GDMT refers to initial medical therapy with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin-receptor blockers (ARB), beta-blockers (BB), and mineralocorticoid receptor antagonists (MRA) titrating to maximally tolerated doses for patients with HFrEF. Cardiac implantable electronic devices (CIEDs) such as the implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) have also become a mainstay in the management of HFrEF after implementation of GDMT. ICD therapy is an effective and established treatment for HFrEF patients for both primary and secondary prevention of SCD. Regarding the use, adherence and results of GDMT after ICD/CRT implantation, there is very limited data available in the literature. There are a few retrospective trials that show this, however very limited randomized controlled data. This proposed study would randomize patients with primary prevention ICDs and CRT into a specialized clinic with a heart failure nurse practitioner vs usual clinical care, with the goal of determining outcomes such as change in LVEFs, heart failure hospitalizations, and visits to the ER for heart failure. Consequently, this would determine whether targeted clinics are needed for ICD/CRT patients with HFrEF to optimize GDMT, improve patient outcomes and thus implement new guidelines/recommendations for this specific patient population.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 23 Jul 2020
- Start date
- 1 Jun 2021
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Ratika Parkash
- Diseases
- Heart failure
- NCT number
- NCT04505007
What you commit to
- Study type: Interventional
- Participants enrolled: 29
- From 1 Jun 2021 to the primary completion date, 1 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- unable to provide informed consent, has a life expectancy of less than one year, dementia, cirrhosis, or metastatic malignancy.
Other
- Patients who underwent primary prevention ICD implantation for arrhythmogenic right ventricular cardiomyopathy (ARVC), ion channelopathies, hypertrophic cardiomyopathy, or infiltrative cardiomyopathy will be excluded from this analysis.
Who the study is looking for
- \- patients who underwent ICD or CRT (pacemaker or defibrillator) implantation therapy at the QEII Health Sciences Centre between 2002 and 2019 and had a left ventricular ejection fraction ≤ 35% at the time of the initial implantation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| QEII Health Sciences Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.