An interventional study of Specialized heart function clinic in Heart Failure and ICD, sponsored by Ratika Parkash. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Ratika Parkash · Not applicable, Interventional, and Supportive care
Among 453 studies in Heart Failure with a site in Canada — 77 open to participants now, 98 under way, 20 of them phase 3. Heart Failure · Canada.
Among the 453 studies in Heart Failure with a site in Canada, this one is the 308th largest by enrollment of the 361 interventional ones that give a count, is one of 23 that started in 2021, is one of 162 with no phase, and was the 328th registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →77 of the 453 studies in Heart Failure with a site in Canada are open now. Recruiting first, the newest first:
AnaCardio AB · Sites in Canada, United States, Bulgaria and 5 more countries
Ages 18–85
AstraZeneca · Sites in Canada, United States, Argentina and 29 more countries
Ages 18+
Ottawa Heart Institute Research Corporation · Sites in Canada
Ages 18+
University Health Network, Toronto · Sites in Canada
Ages 18+
Bayer · Sites in Canada, United States, Argentina and 20 more countries
Ages up to 18
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
453 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 72 · Phase 3 105 · Phase 4 24
First in 1983; this study’s year is marked. 23 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 29 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 225 across the 361 interventional studies, 360 across the 91 observational. Of the 307 that completed or were terminated, 127 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
200 of 453 have an industry lead sponsor. The 10 most frequent:
Ratika Parkash is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Ratika Parkash has 1 study filed under Heart Failure — fewer than ten, so there is no comparison to draw.
29 of the studies in Heart Failure with a site in Canada that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT05873881Phase 3Hamilton Health Sciences CorporationCOLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease | 2027-06 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06024746Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | 2027-11 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
Add all 29 to your calendar (.ics) → With an account.
Among the 453 studies in Heart Failure with a site in Canada, from their registry updates:
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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.
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. Canadian guidelines recommend ICD implantation for patients with ischemic or non-ischemic cardiomyopathy (NICM) and persistent ejection fraction ≤ 30%, when persistent refers to at least 3 months of optimal medical therapy (OMT) in all patients and, in patients with ischemic heart disease, at least 3 months after revascularization and at least 40 days after a myocardial infarction (MI). These guidelines also suggest that ICDs be considered for the same population with a left ventricular ejection fraction (LVEF) of 31-35% as well. CRT device therapy is indicated for use in patients in sinus rhythm with New York Heart Association (NYHA) class II-III, or ambulatory NYHA class IV heart failure symptoms, a LVEF ≤ 35%, and QRS duration > 130 ms because of left bundle branch block (LBBB).
The use and adherence to GDMT before and after ICD implantation is of critical importance. Adherence to GDMT before implantation has the potential to improve survival and may even improve left ventricular ejection fraction (LVEF) enough so that an ICD may no longer be indicated. However, adherence to GDMT is notoriously difficult to assess in conventional clinical practice due a multitude of factors. These include information about outpatient prescription use, prescription filling pattern/barriers, reported patient adherence to GDMT, and various electronic health records/documentation linked to pharmacies to name a few. In one retrospective study, it was demonstrated that just over half (61.1%) of patients filled any GDMT prescription before ICD implantation. Futhermore, patients receiving GDMT versus those who did not receive GMT had a lower 1 year mortality rate after ICD implantation (11.1% vs 16.2%) after adjustments for comorbidities, LVEF, and NYHA class heart failure. In a similar study assessing prescriptions claim data to assess beta-blocker use prior to ICD implantation, the median number of days covered by a beta-blocker in the 90 days prior to ICD implantation was 46 days. From the results of these studies, it is clear that there is room for improvement for implementation of GDMT prior to ICD implantation.
Regarding the use, adherence and results of GDMT after ICD/CRT implantation, there is very limited data available in the literature. One of the first studies to exhibit the effect of medical therapy in HFrEF patients after ICD/CRT implantation was a retrospective cohort study that stratified ICD/CRT patients according to combination treatment with HFrEF medical therapy; patients on none or one HFrEF medications were in group 0/1, patients on two HFrEF medications (ex: ACEi + BB) were in group 2, and patients on all three HFrEF medications (ACEi/ARB + BB + MRA) were in group 3. Results showed a higher hospitalization rate per patient/year in the undertreated population (group 0 and 1) (28% vs 12%, p = 0.001). Also, in multivariate analysis, patients treated with better medical therapy (groups 2 and 3) had less hospitalizations for heart failure and better survival (p \< 0.001). In addition to benefits with hospitalizations and better survival, adjunctive optimization of GDMT can result in quantitative benefits as well. One study compared usual post-implant care was compared to protocol-driven clinical care with a dedicated nurse and cardiologist. Protocol-driven care was associated with significant improvements in LVEF, LV internal diastolic diameter, and improvements in maximum exercise capacity. Interestingly, these improvements appeared to be driven not only by device-related management, but also by concomitant optimization of GDMT and heart failure education. As evidenced by these promising results, it is of utmost importance to assess and optimize the use of GDMT in patients with CIEDs and HFrEF, as there can be potential improvements in LVEF, exercise capacity and survival.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- patients who underwent ICD or CRT (pacemaker or defibrillator) implantation therapy at the QEII Health Sciences Centre between 2002 and 2019 and had a ≤ 35% at the time of the initial implantation.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this arm, patients with devices and heart failure will undergo usual clinical care. This consists of follow-up as deemed necessary by their primary care providers.
In this arm, patients with devices and heart failure will be enrolled in a specialized clinic with the following aims: 1. Referral to a heart failure nurse practitioner to undergo optimization of medical therapy. 2. Optimization of device programming with reduction of ventricular pacing where possible, rate responsiveness when indicated. 3. For those patients with CRT - ECG optimization using a previously tested protocol will be performed. This will consist of attempts to achieve the shortest QRS duration with the following guidelines: 1. Two BV fusion patterns in leads V1 and V2: QRS normalization or a new or an increased R wave. 2. QRS difference ≤-25 ms. Remodelling probability increases as QRS difference takes on larger negative values (QRS difference = BV paced QRS - LBBB QRS duration, in ms).
Other: Specialized heart function clinic
This information has already been provided.
Change in Left Ventricular Ejection Fraction (LVEF)
The proportion of patients that experience more than 10% increase in LVEF. This outcome will demonstrate if the experimental group had benefit in their heart function (ie LVEF). A successful outcome is if the patient demonstrated an increase by at least 10% in the LVEF over the year of follow up.
Time frame: 1 year
Mortality rate
All-cause mortality will demonstrate if the two groups differed in the absolute number of mortality in the 1 year follow up period.
Time frame: 1 year
Heart failure hospitalization frequency
This will determine if the experimental group patients were hospitalized with a different frequency compared to the usual care group during the 1 year follow up period.
Time frame: 1 year
Rate of adherence to guideline directed medical therapy
This outcome will be based on self-reported adherence to combinations of medications for treating heart failure. Patients will provide us details of adherence to their medications as best as possible.
Time frame: 1 year
Plan to share: No
Ran from Jun 2021 to primary completion in Dec 2023, 30 months.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 30 months is close to that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Ratika Parkash