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Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study (CAT-PEF)

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ClinicalTrials.gov Identifier: NCT03195660
Recruitment Status : Terminated (Funding for study was withdrawn)
First Posted : June 22, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
ResMed

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE June 22, 2017
Last Update Posted Date January 8, 2018
Actual Study Start Date  ICMJE June 26, 2017
Actual Primary Completion Date November 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
ASV Adherence [ Time Frame: 3 months ]
Average hours used per day
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03195660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
  • KCCQ-12 [ Time Frame: 3 months ]
    Change in KCCQ-12 score
  • Hospitalizations [ Time Frame: 3 months ]
    Number of hospitalizations per subject
  • Death [ Time Frame: 3 months ]
    Number of deaths
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
Official Title  ICMJE Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
Brief Summary This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the criteria will receive ASV therapy.
Detailed Description

Cardiovascular Improvements with Minute Ventilation-targeted ASV Therapy in Heart Failure Study (CAT-HF) was a randomized controlled clinical trial in the United States and Germany. It was designed to evaluate the effect of ASV in hospitalized heart failure (HFrEF and HFpEF) patients on a global rank endpoint of survival free from CV hospitalization and improvement in functional capacity measured by 6-minute walk distance. Analysis of the 126 subjects that were randomized showed a neutral result for the primary endpoint; however, in the pre-specified analysis of the primary endpoint by LVEF strata, there was a favorable statistically significant difference in the HFpEF subgroup (p=0.036).

Although the CAT-HF study showed a positive signal in the HFpEF subgroup, these patients represented a small percentage of the randomized subjects in the study. The current study aims to show that by applying newer technologies to support adherence, as well as focusing on the lessons learned in CAT-HF to identify and recruit HFpEF patients, acceptable adherence to ASV therapy can be achieved in HFpEF patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, single-arm, un-blinded, multi-center
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure With Normal Ejection Fraction
  • Sleep Apnea
Intervention  ICMJE Device: ASV Therapy
AirCurve 10 ASV device set up in AutoSet mode
Other Name: AirCurve 10 ASV
Study Arms  ICMJE Experimental: ASV Therapy
ASV Therapy
Intervention: Device: ASV Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 8, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2017)
300
Actual Study Completion Date  ICMJE November 15, 2017
Actual Primary Completion Date November 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients 18 years or older
  2. Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%)
  3. Hospital admission or equivalent (such as ER visit alone or clinic visit alone) and acute decompensated HF as determined by:

    1. Dyspnea at rest or with minimal exertion AND
    2. Treatment with at least one dose of IV diuretic or ultrafiltration AND
    3. At least two of the following signs and symptoms:

    i. Orthopnea ii. Pulmonary rales that do not clear with cough iii. Congestion on chest X-ray iv. Local BNP or NT pro-BNP level: A. No current atrial fibrillation (AFib): BNP≥100 pg/mL or NT pro- BNP≥300 pg/mL OR B. Current AFib: BNP≥150 pg/mL or NT pro-BNP≥450 pg/mL

  4. Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr)
  5. Patient is able to fully understand study information and sign informed consent

Exclusion Criteria:

  1. Right-sided heart failure without left-sided failure
  2. Current chronic use (within 4 weeks of study entry) of any PAP therapy (eg, CPAP, APAP, or bi-level) or contraindicated for PAP therapy
  3. Sustained systolic blood pressure <80 mmHg at baseline
  4. Complex congenital heart disease
  5. Constrictive pericarditis
  6. Chronic hypoxemia as evidenced by sustained oxygen saturation ≤ 85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)
  7. Transient ischemic attack (TIA) or Stroke within 3 months prior to study entry
  8. Definite clinically evident acute myocardial infarction within 3 months of study entry
  9. Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas
  10. Moderate or greater valvular heart disease as the primary reason for heart failure
  11. Pregnant, or planning to become pregnant during the study period
  12. In the opinion of the investigator, the index acute decompensated HF event was due primarily to uncontrolled AFib with fast ventricular response rate
  13. Inability to comply with planned study procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03195660
Other Study ID Numbers  ICMJE MA-16-12-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ResMed
Study Sponsor  ICMJE ResMed
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christopher O'Connor, MD Inova Heart and Vascular Institute
PRS Account ResMed
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP