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Evaluation of the effect of short term activation/deactivation of biventricular pacing (BivP) of the CRT (during routine CRT interrogation) on vascular function as assessed via retinal vessel analysis (RVA), in patients treated with CRT.
Heart failure is a condition in which the heart becomes unable to maintain the body's need of blood supply. Congestive heart failure can be considered a syndrome but the final common path of many cardiovascular diseases. Recently, the investigators of this study confirmed an increased impairment in retinal microvascular function in patients with ischemic heart failure compared to patients with stable coronary disease.
If medication fails to improve ejection fraction, cardiac resynchronization therapy (CRT) is the guideline-recommended treatment for patients with advanced heart failure and bundle branch block.
The question remains if CRT changes purely hemodynamics by synchronizing the heart or has potential impact on the microvasculature to cause reverse remodeling of the failing heart. Measuring retinal vascular function might increase knowledge on the effects of cardiac resynchronization therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biventricular Pacing deactivated | Other | The primary objective of the study is to determine, whether short term activation/deactivation of biventricular pacing (BivP) of the CRT (during routine CRT interrogation) has an effect on vascular function |
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| Biventricular Pacing activated | Other | The primary objective of the study is to determine, whether short term activation/deactivation of biventricular pacing (BivP) of the CRT (during routine CRT interrogation) has an effect on vascular function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy (ON vs. OFF) | Device | This study involves study participants, who already received cardiac resynchronisation therapy implantation for clinical reasons. CRT is authorized for medical use by Swissmedic in Switzerland and all implanted devices are CE-approved. |
| Measure | Description | Time Frame |
|---|---|---|
| Flicker-light induced vasodilatation of retinal arterioles assessed by retinal vessel analyzer (RVA) | Difference in flicker-light induced vasodilatation of retinal arterioles between biventricular pacing of the CRT switched ON and OFF. | A single study 1 day visit is planned. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas J Flammer, MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniversitätsSpital Zürich | Zurich | 8091 | Switzerland |
It is not yet decided in what way there will be data sharing.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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Clinical study with a randomized (double-blind) cross-over design
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