Improving Sleep Quality in Heart Failure

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: Heart Failure; Sleep Disturbance

Treatments: Drug: Placebo oral capsule; Drug: Zolpidem Tartrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03307005

IRB00142395

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 21 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Treatment:

Drug: Zolpidem Tartrate

Control

Placebo Comparator group

Treatment:

Drug: Placebo oral capsule