Improving Sleep Quality in Heart Failure

NCT ID: NCT03307005

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-01-25

Brief 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.

Conditions

Sleep Disturbance; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Zolpidem Tartrate

Intervention Type: DRUG

Zolpidem tartrate 5 mg capsule one per night taken for 7 nights

Control

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Placebo capsule one per night taken for 7 nights

Interventions

Zolpidem Tartrate

Zolpidem tartrate 5 mg capsule one per night taken for 7 nights

Intervention Type: DRUG

Placebo oral capsule

Placebo capsule one per night taken for 7 nights

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rashmi Aurora, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Campus, Asthma and Allergy Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00142395

Identifier Type: -

Identifier Source: org_study_id