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Can a heart rate drug keep heart failure patients out of the hospital?

NCT ID NCT03168529

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether starting ivabradine when heart failure patients leave an observation unit safely lowers heart rate and reduces the chance of returning to the hospital or emergency room. The trial enrolls adults with reduced ejection fraction heart failure who are stabilized after an acute episode. Participants receive either ivabradine or a placebo for a period after discharge, and the study measures changes in heart rate using ECG and a wearable patch. The trial also focuses on African American patients, a group often missing from earlier heart failure studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivabradine, a drug that lowers heart rate without weakening the heart's pumping
What this could lead to
If it works, ivabradine could become a routine option for stabilizing heart failure patients right after they leave an observation unit, helping them avoid a quick return to the hospital.
What could go wrong
This is a small Phase 4 trial with only 19 participants, so it may not show a clear benefit or may not apply to all heart failure patients. Ivabradine can cause side effects like vision changes or a slow heart rate, and the short follow-up may miss longer-term risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

19 people

The number who actually took part.

Started

Jul 2018

Finished

Dec 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Wayne State University

    Detroit, Michigan, 48201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.