Can a heart rate drug keep heart failure patients out of the hospital?
NCT ID NCT03168529
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.
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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
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Jul 2018
- Finished
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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
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19 to 89 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Henry Ford Hospital
Detroit, Michigan, 48202, United States
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Wayne State University
Detroit, Michigan, 48201, United States
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