← Back to Search

Other

Specialized Heart Function Clinic Care for Heart Failure

N/A

Waitlist Available

Led By Ratika Parkash, MD

Research Sponsored by Ratika Parkash

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial would aim to improve care for patients with HFrEF who have ICDs or CRTs by randomized them into a specialized clinic with a heart failure nurse practitioner. The hope is that this will lead to better outcomes for these patients.

Who is the study for?

This trial is for patients who had an ICD or CRT device implanted at the QEII Health Sciences Centre between 2002 and 2019, with a heart pumping strength (ejection fraction) ≤35% at implant time. It's not for those unable to consent, with less than one year life expectancy, dementia, severe liver disease (cirrhosis), widespread cancer, or specific genetic heart conditions.Check my eligibility

What is being tested?

The study tests if a specialized clinic led by a heart failure nurse can improve outcomes for patients with weak hearts who have received devices like ICDs/CRTs. Patients are randomly assigned to this special care or usual care to see differences in heart function improvement and hospital visits.See study design

What are the potential side effects?

Since the intervention involves guideline-based medical therapy and specialized clinic follow-up rather than new medications, side effects are not the focus of this trial but may relate to standard treatments used in managing heart failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a pacemaker or defibrillator implanted between 2002 and 2019 with a heart function (ejection fraction) of 35% or less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Left Ventricular Ejection Fraction (LVEF)

Secondary outcome measures

Heart failure hospitalization frequency

Mortality rate

Rate of adherence to guideline directed medical therapy

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Specialized clinicExperimental Treatment1 Intervention

In this arm, patients with devices and heart failure will be enrolled in a specialized clinic with the following aims: Referral to a heart failure nurse practitioner to undergo optimization of medical therapy. Optimization of device programming with reduction of ventricular pacing where possible, rate responsiveness when indicated. 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: Two BV fusion patterns in leads V1 and V2: QRS normalization or a new or an increased R wave. 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).

Group II: Usual clinical careActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityOTHER

258 Previous Clinical Trials

83,825 Total Patients Enrolled

1 Trials studying Heart Failure

150 Patients Enrolled for Heart Failure

Ratika ParkashLead Sponsor

4 Previous Clinical Trials

3,776 Total Patients Enrolled

Ratika Parkash, MDPrincipal InvestigatorNSHA

1 Previous Clinical Trials

360 Total Patients Enrolled

Media Library

Guideline-Directed Medical Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04505007 — N/A

Heart Failure Research Study Groups: Specialized clinic, Usual clinical care

Heart Failure Clinical Trial 2023: Guideline-Directed Medical Therapy Highlights & Side Effects. Trial Name: NCT04505007 — N/A

Guideline-Directed Medical Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04505007 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit on participant recruitment for this research project?

"Yes, the information on clinicaltrials.gov shows that this trial is currently enrolling participants. This experiment was first published on June 1st 2021 and has since been revised as of July 19th 2022. In total, 200 patients are being recruited from a single site."

Answered by AI