Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients

Status Completed

Clinical Trial Summary

The objective of the study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.

Clinical Trial Description

The ASAP-HF study is a prospective, randomized, controlled, two-center, study with a parallel group design, with subjects randomized to either control (no APAP) or active treatment (APAP) in a 1:1 ratio. Group A (active): standard medical therapy plus treatment with continuous APAP for 48hrs, or Group B (control): standard medical therapy only.

Many people who have heart failure (HF) also have sleep-disordered breathing (SDB), which is breathing irregularities during sleep. These irregularities may interrupt the sleep as well as increase the rate of progression of Heart Failure. The ASAP-HF study is being done to see if certain clinical outcomes are improved in acute decompensated heart failure (HF) patients with SDB by using a non-invasive breathing device continuously for a short period of time (48 hours) while patient is still in the hospital. The device is called AirSense™ 10 AutoSet (AutoSet). It consists of an air flow generator, air tubing, an air humidifier, and a mask. As the patient breathe through the mask, the AutoSet monitors breathing.

The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters . This device is not currently used to diagnose sleep apnea and its utility is not well studied. This study will establish the utility of the device in diagnosing sleep apnea. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02963597
Study type	Interventional
Source	Albert Einstein Healthcare Network
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2016
Completion date	August 15, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Recruiting	`NCT05650307` - CV Imaging of Metabolic Interventions
Recruiting	`NCT05654272` - Development of CIRC Technologies
Active, not recruiting	`NCT05896904` - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction	N/A
Completed	`NCT05077293` - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting	`NCT05631275` - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation	`NCT05564572` - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology	N/A
Enrolling by invitation	`NCT05009706` - Self-care in Older Frail Persons With Heart Failure Intervention	N/A
Recruiting	`NCT04177199` - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated	`NCT03615469` - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)	N/A
Recruiting	`NCT06340048` - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure	Phase 1/Phase 2
Recruiting	`NCT05679713` - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed	`NCT04254328` - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure	N/A
Completed	`NCT03549169` - Decision Making for the Management the Symptoms in Adults of Heart Failure	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Enrolling by invitation	`NCT05538611` - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting	`NCT04262830` - Cancer Therapy Effects on the Heart
Completed	`NCT06026683` - Conduction System Stimulation to Avoid Left Ventricle Dysfunction	N/A
Withdrawn	`NCT03091998` - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support	Phase 1
Recruiting	`NCT05564689` - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients With Sleep Apnea. — ASAP-HF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms