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

NCT ID: NCT04379401

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-06-20

Brief 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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: OTHER

Cardiac Resynchronization Therapy (ON vs. OFF)

Intervention Type: 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.

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

Group Type: OTHER

Cardiac Resynchronization Therapy (ON vs. OFF)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andreas Flammer

OTHER

Sponsor Role: lead

Responsible Party

Andreas Flammer

PD Dr. med. Andreas Flammer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andreas J Flammer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

UniversitätsSpital Zürich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

RVACRT

Identifier Type: -

Identifier Source: org_study_id