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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy (ON vs. OFF)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • UniversitätsSpital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Biventricular Pacing deactivated; 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	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.
Other: Biventricular Pacing activated; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Andreas Flammer
• Investigators: Principal Investigator: Andreas J Flammer, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RVACRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet decided in what way there will be data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No