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

NCT02796638 | Unknown DMC

• 1 other identifier: H150082
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Sleep Apnea, Obstructive

Keywords

Acute Heart Failure; Positive-Pressure Ventilation; Adaptive Servo-Ventilation

Outcome Measures

Primary Outcomes (1)

• Change in Renal Biomarkers

  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

  30 days post-discharge

Secondary Outcomes (7)

• Change in Renal Biomarkers

  up to 90 days post-discharge

• Reduction in Decrease of eGFR

  up to 30 days post-discharge

• Reduction in Decrease of eGFR

  up to 90 days post-discharge

• Disposition and post-discharge composite events

  up to 30 days post-discharge

• Disposition and post-discharge composite events

  up to 90 days post-discharge

Study Arms (2)

Minute Ventilation Adaptive Servo-Ventilation plus SOC

EXPERIMENTAL

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

Standard of Care (SOC)

NO INTERVENTION

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.

Interventions

Adaptive Servo-Ventilation DEVICE

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

Minute Ventilation Adaptive Servo-Ventilation plus SOC

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• ResMed Foundation: collaborator

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (4)

• Ronco C, McCullough PA, Anker SD, Anand I, Aspromonte N, Bagshaw SM, Bellomo R, Berl T, Bobek I, Cruz DN, Daliento L, Davenport A, Haapio M, Hillege H, House A, Katz NM, Maisel A, Mankad S, Zanco P, Mebazaa A, Palazzuoli A, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G, Zamperetti N, Ponikowski P. Cardiorenal syndromes: an executive summary from the consensus conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2010;165:54-67. doi: 10.1159/000313745. Epub 2010 Apr 20.

  PMID: 20427956 RESULT

• Ronco C, Cicoira M, McCullough PA. Cardiorenal syndrome type 1: pathophysiological crosstalk leading to combined heart and kidney dysfunction in the setting of acutely decompensated heart failure. J Am Coll Cardiol. 2012 Sep 18;60(12):1031-42. doi: 10.1016/j.jacc.2012.01.077. Epub 2012 Jul 25.

  PMID: 22840531 RESULT

• McCullough PA, Bouchard J, Waikar SS, Siew ED, Endre ZH, Goldstein SL, Koyner JL, Macedo E, Doi K, Di Somma S, Lewington A, Thadhani R, Chakravarthi R, Ice C, Okusa MD, Duranteau J, Doran P, Yang L, Jaber BL, Meehan S, Kellum JA, Haase M, Murray PT, Cruz D, Maisel A, Bagshaw SM, Chawla LS, Mehta RL, Shaw AD, Ronco C. Implementation of novel biomarkers in the diagnosis, prognosis, and management of acute kidney injury: executive summary from the tenth consensus conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2013;182:5-12. doi: 10.1159/000349962. Epub 2013 May 13.

  PMID: 23689652 RESULT

• Ng LL, Sandhu JK, Narayan H, Quinn PA, Squire IB, Davies JE, Bergmann A, Maisel A, Jones DJ. Proenkephalin and prognosis after acute myocardial infarction. J Am Coll Cardiol. 2014 Jan 28;63(3):280-9. doi: 10.1016/j.jacc.2013.09.037. Epub 2013 Oct 16.

  PMID: 24140658 RESULT

MeSH Terms

Conditions

Heart Failure; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Nancy J Gardetto, Ph.D.

  Veterans Affairs San Diego Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 13, 2016
• Study Start: October 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2021
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)