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

Primary Purpose

Heart Failure With Normal Ejection Fraction, Sleep Apnea

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

ASV Therapy

About this trial

This is an interventional treatment trial for Heart Failure With Normal Ejection Fraction focused on measuring adaptive servo-ventilation, ASV, HFpEF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients 18 years or older
Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%)
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
Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr)
Patient is able to fully understand study information and sign informed consent

Exclusion Criteria:

Right-sided heart failure without left-sided failure
Current chronic use (within 4 weeks of study entry) of any PAP therapy (eg, CPAP, APAP, or bi-level) or contraindicated for PAP therapy
Sustained systolic blood pressure <80 mmHg at baseline
Complex congenital heart disease
Constrictive pericarditis
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)
Transient ischemic attack (TIA) or Stroke within 3 months prior to study entry
Definite clinically evident acute myocardial infarction within 3 months of study entry
Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas
Moderate or greater valvular heart disease as the primary reason for heart failure
Pregnant, or planning to become pregnant during the study period
In the opinion of the investigator, the index acute decompensated HF event was due primarily to uncontrolled AFib with fast ventricular response rate
Inability to comply with planned study procedures

Sites / Locations

University of California San Diego
Thomas Jefferson University
Inova Heart and Vascular Institute
Heart and Diabetes Center - West Rhine-Westphalia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASV Therapy

Arm Description

ASV Therapy

Outcomes

Primary Outcome Measures

ASV Adherence

Average hours used per day

Secondary Outcome Measures

KCCQ-12

Change in KCCQ-12 score. Cardiomyopathy Questionnaire (Kansas City) (KCCQ-12) is a short questionnaire to evaluate quality of life in heart failure patients. All scores are scaled from 0-100 where low scares represent very poor health and high scores represent excellent health.

Hospitalizations

Number of hospitalizations per subject

Death

Number of deaths

Full Information

NCT ID

NCT03195660

First Posted

June 20, 2017

Last Updated

April 20, 2021

Sponsor

ResMed

1. Study Identification

Unique Protocol Identification Number

NCT03195660

Brief Title

Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study

Acronym

CAT-PEF

Official Title

Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

Funding for study was withdrawn

Study Start Date

June 26, 2017 (Actual)

Primary Completion Date

November 15, 2017 (Actual)

Study Completion Date

November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure With Normal Ejection Fraction, Sleep Apnea

Keywords

adaptive servo-ventilation, ASV, HFpEF

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, single-arm, un-blinded, multi-center

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASV Therapy

Arm Type

Experimental

Arm Description

ASV Therapy

Intervention Type

Device

Intervention Name(s)

ASV Therapy

Other Intervention Name(s)

AirCurve 10 ASV

Intervention Description

AirCurve 10 ASV device set up in AutoSet mode

Primary Outcome Measure Information:

Title

ASV Adherence

Description

Average hours used per day

Time Frame

3 months

Secondary Outcome Measure Information:

Title

KCCQ-12

Description

Time Frame

3 months

Title

Hospitalizations

Description

Number of hospitalizations per subject

Time Frame

3 months

Title

Death

Description

Number of deaths

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients 18 years or older Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%) Hospital admission or equivalent (such as ER visit alone or clinic visit alone) and acute decompensated HF as determined by: Dyspnea at rest or with minimal exertion AND Treatment with at least one dose of IV diuretic or ultrafiltration AND 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 Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr) Patient is able to fully understand study information and sign informed consent Exclusion Criteria: Right-sided heart failure without left-sided failure Current chronic use (within 4 weeks of study entry) of any PAP therapy (eg, CPAP, APAP, or bi-level) or contraindicated for PAP therapy Sustained systolic blood pressure <80 mmHg at baseline Complex congenital heart disease Constrictive pericarditis 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) Transient ischemic attack (TIA) or Stroke within 3 months prior to study entry Definite clinically evident acute myocardial infarction within 3 months of study entry Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas Moderate or greater valvular heart disease as the primary reason for heart failure Pregnant, or planning to become pregnant during the study period In the opinion of the investigator, the index acute decompensated HF event was due primarily to uncontrolled AFib with fast ventricular response rate Inability to comply with planned study procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher O'Connor, MD

Organizational Affiliation

Inova Heart and Vascular Institute

Official's Role

Study Chair

Facility Information:

Facility Name

University of California San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Inova Heart and Vascular Institute

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Heart and Diabetes Center - West Rhine-Westphalia

City

Bad Oeynhausen

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

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Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study

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