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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Recruitment Status : Terminated (Funding for study was withdrawn)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

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.

Condition or disease Intervention/treatment Phase
Heart Failure With Normal Ejection Fraction Sleep Apnea Device: ASV Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single-arm, un-blinded, multi-center
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
Actual Study Start Date : June 26, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: ASV Therapy
ASV Therapy
Device: ASV Therapy
AirCurve 10 ASV device set up in AutoSet mode
Other Name: AirCurve 10 ASV




Primary Outcome Measures :
  1. ASV Adherence [ Time Frame: 3 months ]
    Average hours used per day


Secondary Outcome Measures :
  1. KCCQ-12 [ Time Frame: 3 months ]
    Change in KCCQ-12 score

  2. Hospitalizations [ Time Frame: 3 months ]
    Number of hospitalizations per subject

  3. Death [ Time Frame: 3 months ]
    Number of deaths



Information from the National Library of Medicine

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

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

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): NCT03195660


Locations
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United States, California
University of California San Diego
San Diego, California, United States, 92123
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Inova Heart and Vascular Institute
Falls Church, Virginia, United States, 22042
Germany
Heart and Diabetes Center - West Rhine-Westphalia
Bad Oeynhausen, Germany
Sponsors and Collaborators
ResMed
Investigators
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Study Chair: Christopher O'Connor, MD Inova Heart and Vascular Institute

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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT03195660     History of Changes
Other Study ID Numbers: MA-16-12-01
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by ResMed:
adaptive servo-ventilation
ASV
HFpEF
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases