Acute Impact of Cardiac Resynchronization on Vascular Function (RVA-CRT)

Heart Failure Clinical Trial

— RVA-CRT  

Official title:

Acute Impact of Cardiac Resynchronization on Vascular Function (RVA-CRT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379401
• Other study ID #: RVACRT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: July 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature

• Patients = 18 years of age, male or female, diagnosed with advanced heart failure

• Implanted as well as activated CRT device for at least 3 months prior to Visit 1

Exclusion Criteria:

• Current acute decompensated HF

• Documented pacing dependency

• Documented AV-Block II (Mobitz Typ 2) or III in patient's history

• History of hypersensitivity or allergy to Tropicamide

• Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular (CV) surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within 3 months prior to Visit 1.

• History of heart transplant, on a transplant list or with ventricular assistance device (VAD).

• Presence of any other disease with a life expectancy of < 6 months

• Presence of significant endocrine diseases, including primary hyperparathyroidism, Cushing's disease, adrenal insufficiency, pituitary tumors, primary hyperaldosteronism, manifest hyperthyroidism or genetic endocrine disorders

• Presence of active acute infectious diseases.

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc

• Women who are pregnant or breast feeding

• Known narrow-angle glaucoma

• Known epilepsy (flicker-light could trigger a seizure)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy (ON vs. OFF)
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.

Locations

Country	Name	City	State
Switzerland	UniversitätsSpital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Andreas Flammer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.