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Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients (ARIA-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00804349
Recruitment Status : Completed
First Posted : December 8, 2008
Results First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
Nexan Inc
Information provided by (Responsible Party):
Albert Einstein Healthcare Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Heart Failure
Sleep Apnea Syndromes
Intervention Device: Autotitrating Positive Airway Pressure
Enrollment 6
Recruitment Details 0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Pre-assignment Details 0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Arm/Group Title Control Autotitrating Positive Airway Pressure
Hide Arm/Group Description

Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.

0 participants analyzed. The study was closed and the PI is not longer at the institution. The PI was contacted to complete requirements but the information was not added by the PI. No study data are available.

Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.

Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy

0 participants analyzed. The study was closed and the PI is not longer at the institution. The PI was contacted to complete requirements but the information was not added by the PI. No study data are available.

Period Title: Overall Study
Started 0 [1] 0 [2]
Completed 0 [2] 0 [2]
Not Completed 0 0
[1]
0 analyzed PI no longer at institution;PI contacted, information not added; No data available.
[2]
0 analyzed PI no longer at institution;PI contacted, information not added; No data available
Arm/Group Title Control Autotitrating Positive Airway Pressure Total
Hide Arm/Group Description

Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.

Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Age, Continuous  
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title Reduction in Episodic Oxygen Desaturation
Hide Description 0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Time Frame Concurrent
Hide Outcome Measure Data
Hide Analysis Population Description
0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Arm/Group Title Control Autotitrating Positive Airway Pressure
Hide Arm/Group Description:

Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.

Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Readmission
Hide Description 0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Time Frame 30 days post discharge
Hide Outcome Measure Data
Hide Analysis Population Description
0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Arm/Group Title Control Autotitrating Positive Airway Pressure
Hide Arm/Group Description:

Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.

Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Length of Stay
Hide Description 0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Time Frame Concurrent
Hide Outcome Measure Data
Hide Analysis Population Description
0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Arm/Group Title Control Autotitrating Positive Airway Pressure
Hide Arm/Group Description:

Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.

Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Visual Analog Scale of Shortness of Breath
Hide Description 0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Time Frame Concurrent
Hide Outcome Measure Data
Hide Analysis Population Description
0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Arm/Group Title Control Autotitrating Positive Airway Pressure
Hide Arm/Group Description:

Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.

Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Adverse Event Reporting Description 0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
 
Arm/Group Title Control Autotitrating Positive Airway Pressure
Hide Arm/Group Description

Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.

Autotitrating Positive Airway Pressure: Patients will be treated with Autotitrating Positive Airway Pressure therapy

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

All-Cause Mortality
Control Autotitrating Positive Airway Pressure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Control Autotitrating Positive Airway Pressure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Autotitrating Positive Airway Pressure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roberta Costello; Research Compliance
Organization: Albert Einstein Healthcare Network
Phone: 215-456-7225
EMail: bcostell@einstein.edu
Layout table for additonal information
Responsible Party: Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT00804349    
Other Study ID Numbers: HN-3025
First Submitted: December 5, 2008
First Posted: December 8, 2008
Results First Submitted: February 24, 2020
Results First Posted: March 9, 2020
Last Update Posted: March 9, 2020