Assessing Ivabradine's effectiveness after discharge for heart failure

A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy of Ivabradine Initiated at the Time of Discharge From the Observation Unit

This study is testing if starting Ivabradine right after leaving the hospital can help people with heart failure stay healthy and avoid going back to the hospital.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 19 Years to 89 Years
• Sex: All
• Sponsor: Wayne State University (Academic / other)
• Locations: 2 sites (Detroit, Michigan and 1 other locations)
• Trial ID: NCT03168529 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Ivabradine, a medication known to reduce hospitalizations for worsening heart failure, when initiated at the time of discharge from an observation unit. Participants will be enrolled upon discharge, and their health will be monitored through follow-up visits at 14 and 28 days post-discharge. The study aims to determine the safety and efficacy of Ivabradine in patients with acute heart failure who are stabilized and discharged, as previous studies have not included this specific patient population. The trial will also assess the impact of Ivabradine on heart rate and overall heart failure management.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with established heart failure and reduced ejection fraction who have been treated in an observation unit for acute heart failure.

Not a fit: Patients who are intolerant to Ivabradine, have end-stage renal disease, or are planning to titrate beta blockers at discharge may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that reduces hospital readmissions and improves outcomes for patients with heart failure.

How similar studies have performed: While Ivabradine has shown promise in other settings, this specific approach of initiating treatment at discharge from an observation unit is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age \>18 and \<90.
2. Established HF with reduced ejection fraction (EF ≤35 %), assessment done within 12 months of index visit.
3. Admitted under observation unit for management of AHF.
4. Heart rate ≥70 beats per minute, with sinus rhythm.
5. Receiving guideline based medical therapy in the judgement of the treating physician.
6. Patient currently on a Beta Blocker regimen. Achieved clinically determined stabilization during treatment under observation unit such that the treating physician is planning to discharge home without hospital admission.

Exclusion Criteria:

1. Known intolerance to study drug.
2. End stage renal disease.
3. Plan to titrate BB at the time of discharge from the observation unit.
4. Any condition that in the opinion of the investigators will interfere with the ability to complete the study (e.g. history of extreme non-adherence, extreme psychosocial instability).
5. Inability to provide written informed consent.
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (women of childbearing age will be included only if they agree to use adequate contraceptive methods or engage in sexual abstinence).
7. Systolic Blood pressure less than 100 mmHg.
8. Sick sinus syndrome, sinoatrial block or 3rd degree AV block, unless a functioning demand pacemaker is present.
9. Severe hepatic impairment.
10. Pacemaker dependence (i.e. heart rate maintained exclusively by the pacemaker).
11. Concomitant use of strong CYP3A4 inhibitors. Examples of strong CYP3A4 inhibitors include azole antifungals (e.g., itraconazole), macrolide antibiotics (e.g., clarithromycin, telithromycin), HIV protease inhibitors (e.g., nelfinavir), and nefazodone.
12. Concomitant use of diltiazem or verapamil that are not planned for discontinuation.
13. Severe, left sided valvular abnormalities (severe aortic stenosis, severe mitral stenosis, severe aortic insufficiency or severe mitral regurgitation.
14. Documented, prior to or at the time of randomization, restrictive amyloid cardiomyopathy, or acute myocarditis, or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.

Where this trial is running

Detroit, Michigan and 1 other locations

• Wayne State University — Detroit, Michigan, United States (Recruiting)
• Henry Ford Hospital — Detroit, Michigan, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Patrick Medado

Conditions Heart Failure; Acute Heart Failure; Observation; Ivabradine