Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adaptive Servo-Ventilation In Acute Heart Failure Patients Protecting the Heart and Kidneys (ASLEEP PK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02796638
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Sponsor:
Collaborator:
ResMed Foundation
Information provided by (Responsible Party):
Alan Maisel, Veterans Medical Research Foundation

Brief Summary:
The primary hypothesis of this study is: the use of minute ventilation-adaptive servo-ventilation (MV-ASV) during hospitalization will mitigate deterioration in renal function and prevent kidney injury in patients admitted with acute heart failure (AHF) compared to those receiving usual care. We will validate and extend our pilot study by taking a deeper dive into the effects of ASV on diuretic dose, urine output and new and exciting biomarkers of renal function and kidney injury. If our hypothesis proves correct, it strongly suggests that ASV lessens injury to the kidney and could lead to a new paradigm for the treatment of AHF. When use of high dose of diuretics are anticipated or in whom chronic kidney disease (CKD) or acute kidney injury (AKI) is present on arrival to the Emergency Department, use of MV-ASV might decrease the amount of diuretics needed, allow for continued use of ACE inhibitors, and ultimately mitigate rises in creatinine and decreases in effective glomerular filtration. Since kidney injury is a major factor in those patients with early 30-day readmission following discharge, this therapy could become quite popular.

Condition or disease Intervention/treatment Phase
Heart Failure Sleep Apnea, Obstructive Device: Adaptive Servo-Ventilation Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptive Servo-Ventilation In Acute Heart Failure Patients Protecting the Heart
Study Start Date : October 2015
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Minute Ventilation Adaptive Servo-Ventilation plus SOC
Patients in this arm will be instructed to use the adaptive servo-ventilation (ASV) device for up to five days of inpatient stay while in the hospital. Patients are encouraged to use the device during any and all hours of sleep, and as needed during waking hours. Apart from this treatment, no other interventions will be administered, and the patient's standard of care will not otherwise be altered for the purposes of the study.Two 6-mL tubes of blood will be drawn once daily for up to 5 days, and daily questionnaires will be administered regarding sleep and health quality.
Device: Adaptive Servo-Ventilation
A positive pressure airway device that increases and decreases inspiration pressure in concordance with the patient's natural breathing cycles.

No Intervention: Standard of Care (SOC)
Patients in this arm will not have their standard of care as dictated by their provider altered in any way. Two 6-mL tubes of blood will be drawn once daily for up to 5 days, and daily questionnaires will be administered regarding sleep and health quality.



Primary Outcome Measures :
  1. Change in Renal Biomarkers [ Time Frame: 30 days post-discharge ]
    Mean paired change in measured blood urea nitrogen (BUN), serum creatinine (> 0.3 mg/dL increase in 48 hours), neutrophil gelatinase-associated lipocalin (NGAL), Pro-encephalin (Penkid), and endothelin


Secondary Outcome Measures :
  1. Change in Renal Biomarkers [ Time Frame: up to 90 days post-discharge ]
    Mean paired change in measured blood urea nitrogen (BUN), serum creatinine (> 0.3 mg/dL increase in 48 hours), neutrophil gelatinase-associated lipocalin (NGAL), Pro-encephalin (Penkid), and endothelin

  2. Reduction in Decrease of eGFR [ Time Frame: up to 30 days post-discharge ]
    A hypothesized reduction in eGFR decrease of 25% in the treatment group compared to the control group

  3. Reduction in Decrease of eGFR [ Time Frame: up to 90 days post-discharge ]
    A hypothesized reduction in eGFR decrease of 25% in the treatment group compared to the control group

  4. Disposition and post-discharge composite events [ Time Frame: up to 30 days post-discharge ]
    To assess patients for composite 30 days events, reduction of subendocardial ischemia in the hospital and at 30 days, reduction of LV wall stress and volume in the hospital and at 30 days; to assess patients for endothelial function, inflammation, and propensity toward fibrosis in the hospital and at 30 days, all of which can influence renal function.

  5. Disposition and post-discharge composite events [ Time Frame: up to 90 days post-discharge ]
    To assess patients for composite 30 days events, reduction of subendocardial ischemia in the hospital and at 90 days, reduction of LV wall stress and volume in the hospital and at 90 days; to assess patients for endothelial function, inflammation, and propensity toward fibrosis in the hospital and at 30 days, all of which can influence renal function

  6. Other markers of renal function [ Time Frame: up to 30 days post-discharge ]
    To assess patients for cumulative dose of loop diuretic, urine output, blood urea nitrogen, incidence of acute kidney injury (AKI), biomarkers of AKI, eGFR at 30 days, mean paired change in urinary biomarker levels, and serum creatinine.

  7. Other markers of renal function [ Time Frame: up to 90 days post-discharge ]
    To assess patients for cumulative dose of loop diuretic, urine output, blood urea nitrogen, incidence of acute kidney injury (AKI), biomarkers of AKI, eGFR at 30 days, mean paired change in urinary biomarker levels, and serum creatinine.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years and older.
  2. Admitted with a clinical diagnosis of acute heart failure.
  3. Evidence of congestion (rales, JVP, CXR, edema).
  4. BNP >300pg/mL
  5. If BMI >35 kg/m2, then BNP >100 pg/ml.
  6. Consent within 24 hours of admission, but every attempt will be made to consent within six hours.
  7. Patients with known sleep disordered breathing (SDB) can be included.
  8. One-half of patients in each group will have chronic kidney disease (CKD) with GFR less than 60.

Exclusion Criteria:

  1. Age < 18 years.
  2. Unable to provide informed consent within 24 hours of admission.
  3. Current participation in a pharmaceutical or treatment-related clinical study.
  4. Intubated.
  5. Hypercarbic (ie. Acute Respiratory Acidosis) from reasons other than acute heart failure.
  6. Cardiogenic shock.
  7. Clinical diagnosis of COPD exacerbation as the primary reason for hospital admission.
  8. History of non-compliance to medications and treatment.
  9. Pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796638


Contacts
Layout table for location contacts
Contact: Alan S Maisel, M.D. (858) 552-8585 ext 7344 alan.maisel@va.gov

Locations
Layout table for location information
United States, California
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact: Alan S Maisel, M.D.    858-552-8585 ext 7344    alan.maisel@va.gov   
Contact: Steve Carter, BS    858-552-8585 ext 2893    steve.carter@va.gov   
Sponsors and Collaborators
Veterans Medical Research Foundation
ResMed Foundation
Investigators
Layout table for investigator information
Principal Investigator: Alan S Maisel Veterans Affairs San Diego Healthcare System

Publications of Results:

Layout table for additonal information
Responsible Party: Alan Maisel, Staff Physician, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02796638     History of Changes
Other Study ID Numbers: H150082
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be de-identified and used only within our local research group.

Keywords provided by Alan Maisel, Veterans Medical Research Foundation:
Acute Heart Failure
Positive-Pressure Ventilation
Adaptive Servo-Ventilation

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Sleep Apnea, Obstructive
Heart Diseases
Cardiovascular Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases