Phase 4 N=5 Randomized Double-blind Treatment

Improving Sleep Quality in Heart Failure

Sleep Disturbance · Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03307005 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Sleep Latency — -73.3; 21.9 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Zolpidem Tartrate (Drug); Placebo oral capsule (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Sleep Latency	-73.3; 21.9	—
PRIMARY Total Sleep Time	67.8; -87.3	—
PRIMARY Sleep Efficiency	7.3; -5.5	—

Summary

Poor sleep quality is common in patients with heart failure. The limited available evidence intimates that improving sleep quality in patients with heart failure may improve morbidity and quality of life in this patient population. However, there is a paucity of evidence assessing the use of effective pharmacologic therapies in heart failure. The nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable benefits over traditional benzodiazepines as a soporific medication. The investigators hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.

Eligibility Criteria

Inclusion Criteria

Age 21-79 years old
HFrEF, EF ≤ 45% (by echocardiography)
NYHA functional class I to III
Able to give written consent
On goal-directed medical therapy for HF, with stable dosing of HF medications for 2 weeks prior to enrollment
No hospitalizations for HF within the past month
Positive response to experiencing any of the following sleep-related symptoms at least once a week:
Difficulty falling asleep
Waking up during the night and having difficulty getting back to sleep
Waking up too early in the morning and being unable to get back to sleep.

Exclusion Criteria

Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks
Current treatment with other sedating medications such as opioids
On therapy for pharmacological therapy for depression
History of alcohol/drug dependence
History of liver disease, HIV, or severe COPD
On Thorazine
Current use of ketoconazole
Current use of tricyclic antidepressants
Current use of macrolide antibiotics
Current use of anticonvulsant medications
Pregnancy. A urine pregnancy test will be performed to exclude pregnancy in potential subjects.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03307005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.