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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03195660
Other study ID # MA-16-12-01
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 26, 2017
Est. completion date November 15, 2017

Study information

Verified date April 2021
Source ResMed
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date November 15, 2017
Est. primary completion date November 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ASV Therapy
AirCurve 10 ASV device set up in AutoSet mode

Locations

Country Name City State
Germany Heart and Diabetes Center - West Rhine-Westphalia Bad Oeynhausen
United States Inova Heart and Vascular Institute Falls Church Virginia
United States Thomas Jefferson University Philadelphia Pennsylvania
United States University of California San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
ResMed

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary ASV Adherence Average hours used per day 3 months
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. 3 months
Secondary Hospitalizations Number of hospitalizations per subject 3 months
Secondary Death Number of deaths 3 months
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