Cardiovascular Improvements With MV ASV Therapy in Heart Failure
(CAT-HF Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen byChristopher O'Connor, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: ResMed

No Placebo Group

Trial Summary

What is the purpose of this trial?

The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF. The study will also assess changes in functional parameters, biomarkers, quality of life (QOL), and sleep.

Research Team

Christopher O'Connor, MD

Principal Investigator

Duke University

Eligibility Criteria

Inclusion Criteria

Patients 21 years or older

Patients with prior clinical diagnosis of heart failure (HFrEF or HFpEF), or de novo diagnosis of HFpEF indicated by a local BNP≥300 pg/mL or NT pro-BNP≥1200 pg/mL on admission without systolic blood pressure >180 mmHg or atrial fibrillation, or diagnosis of HFrEF indicated by documented evidence of prescribed beta-blockers and ACE-inhibitors or ARBs for at least 4 weeks prior to admission

Dyspnea at rest or with minimal exertion

See 7 more

Treatment Details

Interventions

MV ASV (Device)
Optimized Medical Treatment (Other)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: MV ASV+OMTExperimental Treatment2 Interventions

Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment

Group II: OMT onlyActive Control1 Intervention

Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines.

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Who Is Running the Clinical Trial?

ResMed

Lead Sponsor

Trials

138

Recruited

47,600+

Mick Farrell

ResMed

Chief Executive Officer since 2013

Bachelor of Engineering from the University of New South Wales, Master of Science in Chemical Engineering from MIT, MBA from MIT Sloan School of Management