Heart Failure With Normal Ejection Fraction, Sleep Apnea
Conditions
Keywords
adaptive servo-ventilation, ASV, HFpEF
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.
Interventions
DEVICEASV Therapy
AirCurve 10 ASV device set up in AutoSet mode
Sponsors
ResMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-arm, un-blinded, multi-center
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASV Adherence | 3 months | Average hours used per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KCCQ-12 | 3 months | 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 | 3 months | Number of hospitalizations per subject |
| Death | 3 months | Number of deaths |
Countries
Germany, United States
Participant flow
Pre-assignment details
Six participants overall were consented for the study, and baseline data on these participants was collected at the baseline visit. Following on from this, four participants did not meet the entry criteria for the study. Two participants started ASV therapy, but the study was terminated before the follow up period.
Participants by arm
| Arm | Count |
|---|---|
| ASV Therapy ASV Therapy
ASV Therapy: AirCurve 10 ASV device set up in AutoSet mode | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | The study was terminated | 2 |
Baseline characteristics
| Characteristic | ASV Therapy |
|---|---|
| Age, Continuous | 63 years |
| Ejection fraction | 64.5 percent |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
ASV Adherence
Average hours used per day
Time frame: 3 months
Population: The study was terminated prior to the follow-up period
Secondary
Death
Number of deaths
Time frame: 3 months
Population: The study was terminated prior to the follow-up period
Secondary
Hospitalizations
Number of hospitalizations per subject
Time frame: 3 months
Population: The study was terminated prior to the follow-up period
Secondary
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.
Time frame: 3 months
Population: The study was terminated prior to the follow-up period