Adaptive Servo-Ventilation In Acute Heart Failure Patients Protecting the Heart and Kidneys
Status unconfirmed · Not applicable
Conditions studied: Heart Failure, Sleep Apnea, Obstructive
In brief
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.
Key facts
- Study ID
- NCT02796638
- Run by
- Veterans Medical Research Foundation
- People needed
- 22
- Starts
- 2015-10-01
- Expected to finish
- 2021-04-01
- Last updated by the study team
- 2020-01-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years and older.
- Admitted with a clinical diagnosis of acute heart failure.
- Evidence of congestion (rales, JVP, CXR, edema).
- BNP >300pg/mL
- If BMI >35 kg/m2, then BNP >100 pg/ml.
- Consent within 24 hours of admission, but every attempt will be made to consent within six hours.
- Patients with known sleep disordered breathing (SDB) can be included.
- One-half of patients in each group will have chronic kidney disease (CKD) with GFR less than 60.
You may not qualify if…
- Age < 18 years.
- Unable to provide informed consent within 24 hours of admission.
- Current participation in a pharmaceutical or treatment-related clinical study.
- Intubated.
- Hypercarbic (ie. Acute Respiratory Acidosis) from reasons other than acute heart failure.
- Cardiogenic shock.
- Clinical diagnosis of COPD exacerbation as the primary reason for hospital admission.
- History of non-compliance to medications and treatment.
- Pregnant women.
Where it is running
- VA San Diego Healthcare System — San Diego, California, United States
Full record on ClinicalTrials.gov
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