Improving Sleep Quality in Heart Failure

NCT03307005 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00142395
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Sleep Latency

  Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.

  1 week

• Total Sleep Time

  Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.

  1 week

• Sleep Efficiency

  Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.

  1 week

Other Outcomes (4)

• Insomnia Severity Index

  1 week

• Kansas City Cardiomyopathy Questionnaire

  1 week

• Epworth Sleepiness Scale

  1 week

Study Arms (2)

Intervention

EXPERIMENTAL

Drug: Zolpidem Tartrate

Control

PLACEBO COMPARATOR

Drug: Placebo oral capsule

Interventions

Zolpidem Tartrate DRUG

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

Intervention

Placebo oral capsule DRUG

Placebo capsule one per night taken for 7 nights

Control

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Campus, Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Parasomnias; Heart Failure

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Rashmi Nisha Aurora, MD, MHS
• Organization: Johns Hopkins University

rnaurora@jhmi.edu

443-513-6535

Study Officials

• Rashmi Aurora, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-site, randomized, parallel, placebo controlled, double blind study

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 11, 2017
• Study Start: November 1, 2017
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: February 11, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-02

Locations

US (1)