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Adaptive Servo-Ventilation In Acute Heart Failure Patients Protecting the Heart and Kidneys

NCT02796638 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-01-27

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Adaptive Servo-Ventilation

A positive pressure airway device that increases and decreases inspiration pressure in concordance with the patient's natural breathing cycles.

Sponsors & Collaborators

  • ResMed Foundation

    collaborator OTHER

  • Veterans Medical Research Foundation

    lead OTHER

Principal Investigators

  • Nancy J Gardetto, Ph.D. · Veterans Affairs San Diego Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-04-30
Completion
2021-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796638 on ClinicalTrials.gov