NCT01953874

Cardiovascular Improvements With MV ASV Therapy in Heart Failure

Cardiovascular Improvements With Minute Ventilation-targeted ASV Therapy in Heart Failure (CAT-HF)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a randomized, unblinded, multi-center trial with parallel group design, with subjects randomized to either control (optimized medical therapy for chronic heart failure) or active treatment (optimized medical therapy plus use of MV-targeted ASV) in a 1:1 ratio.

Conditions

• Acute Decompensated Heart Failure
• Sleep Disordered Breathing

Interventions

Type	Name	Description
DEVICE	MV ASV	Minute ventilation-targeted servo-ventilation therapy.
DRUG	Optimized Medical Treatment	Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-10-01
• Last updated: 2018-02-28
• Results posted: 2018-02-28

Locations

15 sites across 2 countries: United States, Germany