Status:

WITHDRAWN

RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF

Lead Sponsor:

WakeMed Health and Hospitals

Conditions:

Heart Failure

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The goal is to evaluate the trends in MouthLab parameters (respiration rate, temperature, pulse rate, electrocardiogram rhythm, blood pressure, oxygen saturation heart rate and basic lung function mea...

Detailed Description

Heart failure (HF) is becoming increasingly recognized with an estimated worldwide prevalence of \>37.7 million individuals. In the United States alone, there are over 5 million patients with HF which...

Eligibility Criteria

Inclusion

  • Inpatient Sub-Study Eligibility Criteria
  • Inclusion Criteria
  • Adults aged ≥ 18 years old
  • Willing and able to provide informed consent
  • Admitted within previous 24 hours with HF exacerbation requiring intravenous diuretic therapy (reduced or preserved ejection fraction)
  • English speaking
  • Exclusion Criteria
  • Currently on dialysis
  • Patients with acute coronary syndrome
  • Currently on hospice
  • Have a heart transplant or left ventricular assist device
  • Outpatient Sub-Study Eligibility Criteria
  • Inclusion Criteria
  • Adults aged ≥ 18 years old
  • Willing and able to provide informed consent
  • Patients presenting to the clinic and not being admitted to the hospital, who have been admitted for a HF exacerbation within the past 6 months, OR patients being discharged from a HF exacerbation related inpatient hospitalization
  • For inclusion in Cohort 2, patients must have Boston Scientific pacemaker or defibrillator with Heart Logic capability
  • For inclusion in Cohort 3, patients must have implantable CardioMEMS device
  • Patients currently on inotropes
  • English speaking
  • Exclusion Criteria
  • Currently on dialysis
  • Currently on hospice
  • Have a heart transplant or left ventricular assist device

Exclusion

    Key Trial Info

    Start Date :

    October 1 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 20 2022

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT04757246

    Start Date

    October 1 2022

    End Date

    October 20 2022

    Last Update

    October 24 2022

    Active Locations (1)

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    1

    WakeMed Health and Hospitals

    Raleigh, North Carolina, United States, 27610