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Cardiovascular Improvements With MV ASV Therapy in Heart Failure | Clinical Trials | Clareo Health

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Cardiovascular Improvements With MV ASV Therapy in Heart Failure

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

NCT01953874•ResMed

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.

Eligibility

Age

21 - No limit years

Sex

ALL

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
+4 more criteria

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)
+19 more criteria

Locations (15)

The Heart Center

Huntsville, Alabama, United States

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

VA Medical Center

Denver, Colorado, United States

Mercer University

Macon, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Maryland

Baltimore, Maryland, United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Key Dates

Start Date

December 1, 2013

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

February 28, 2018

Enrollment

126

ACTUAL participants

Conditions

Acute Decompensated Heart FailureSleep Disordered Breathing

Interventions

MV ASV

DEVICE

Optimized Medical Treatment

DRUG

Add-on Diuretics in Acute Decompensated Heart Failure

NCT07372040

Acute Decompensated Heart Failure

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RECRUITING

Epidemiology of Sleep Disordered Breathing in Children and Young People With Cerebral Palsy

NCT06737302

Cerebral Palsy (CP)Sleep Disordered Breathing (SDB)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cardiovascular Improvements With MV ASV Therapy in Heart Failure

Inclusion Criteria

Exclusion Criteria

Add-on Diuretics in Acute Decompensated Heart Failure

Epidemiology of Sleep Disordered Breathing in Children and Young People With Cerebral Palsy

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure

EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

Neurostimulation for Sleep Disordered Breathing