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

ResMed

Status: Terminated

Conditions: Sleep Disordered Breathing; Acute Decompensated Heart Failure

Treatments: Drug: Optimized Medical Treatment; Device: MV ASV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01953874

MA-12-12-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

• Hospital admission for acute decompensated HF as determined by:

  • Dyspnea at rest or with minimal exertion

    • AND At least two of the following signs and symptoms:

  • Orthopnea

  • Pulmonary rales beyond basilar

  • Chest congestion on x-ray

  • BNP≥300pg/mL or NT pro-BNP≥1200pg/mL

  • Pulmonary capillary wedge pressure (PCWP) ≥25mmHg during current hospitalization

• Presented to hospital or clinic at least 24 hours prior to consent

• Patient stable enough to stop oxygen use for duration of polygraphy test or have access to dual lumen cannula for polygraphy test

• Sleep disordered breathing (SDB) documented by polygraphy with an AHI≥15 events/hour

• Patient is able to fully understand study information and sign a consent form

Exclusion criteria

• Right-sided heart failure without left-sided heart failure
• Sustained systolic blood pressure <80 mmHg at baseline
• Acute coronary syndrome within 1 months of randomization
• Active myocarditis
• Complex congenital heart disease
• Constrictive pericarditis
• Non-cardiac pulmonary edema
• Clinical evidence of digoxin toxicity
• Need for mechanical hemodynamic support at time of randomization
• Oxygen saturation ≤85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)
• COPD exacerbation as the primary reason for hospital admission
• Current use (within 4 weeks of study entry) of any PAP-therapy (eg, fixed, bi-level, or APAP)
• Life expectancy < 1 year for diseases unrelated to HF
• Transient ischemic attack (TIA) or Stroke within 3 months prior to randomization
• CABG procedure within 3 months prior to randomization, or planned to occur during study period
• CRT implant within 3 months prior to randomization , or planned to occur during study period
• VAD implant planned to occur during study period
• Heart transplant list Status 1a or 1b
• Status post-transplant or LVAD
• Prescribed inotrope therapy anticipated at discharge
• Chronic Dialysis
• Known amyloidosis, hypertrophic obstructive cardiomyopathy, arteriovenous fistulas
• Primary hemodynamically significant uncorrected valvular heart disease (obstructive or regurgitant) with planned intervention within 6 months of randomization
• Pregnant, or planning to become pregnant
• Cannot tolerate ASV treatment during run-in
• Cannot perform 6MWT at baseline
• Occupation as a commercial driver or pilot and plan to be performing these activities during the study period
• Inability to comply with planned study procedures
• Participation in pharmaceutical or treatment-related clinical study within 1 month of study enrollment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

MV ASV+OMT

Experimental group

Description:

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

Treatment:

Device: MV ASV

Drug: Optimized Medical Treatment

OMT only

Active Comparator group

Description:

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.

Treatment:

Drug: Optimized Medical Treatment