Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-27 @ 1:50 AM
Study NCT ID:
NCT01164592
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2010-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
Sponsor:
ResMed
Organization:
Study Overview
Official Title:
SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MS
Brief Summary:
The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.
Detailed Description:
This substudy is performed within the SERVE-HF Study, a randomised, multi-centre,international trial with parallel group design, with patients randomised to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. The randomization will be the same as in the parent study. For this purpose, the randomization of the parent study will be stratified as to whether a patient is included in the substudy or not. 300 patients will be recruited for the substudy overall.
For the purpose of this substudy, patients will be followed up for a period of 12 months.
The following extra tests will be performed at the baseline visit, the 3 months follow up and the 12 months follow up:
* Echocardiogram (for both groups)
* cMRI (for both groups)
* PSG (at the baseline visit only for patients in the treatment group and at 3 months follow up and the 12 months follow up for all patients)
* 4 questionnaires (for both groups)
* Additional blood testing (for both groups)
For the purpose of this substudy, patients will be followed up for a period of 12 months.
The following extra tests will be performed at the baseline visit, the 3 months follow up and the 12 months follow up:
* Echocardiogram (for both groups)
* cMRI (for both groups)
* PSG (at the baseline visit only for patients in the treatment group and at 3 months follow up and the 12 months follow up for all patients)
* 4 questionnaires (for both groups)
* Additional blood testing (for both groups)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: