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

NCT04379401 | Completed DMC

• 1 other identifier: RVACRT
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

Device: Cardiac Resynchronization Therapy (ON vs. OFF)

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

Device: Cardiac Resynchronization Therapy (ON vs. OFF)

Interventions

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.

Biventricular Pacing activated; Biventricular Pacing deactivated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Andreas Flammer: lead

Study Sites (1)

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Andreas J Flammer, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med. Andreas Flammer

Model Details: Clinical study with a randomized (double-blind) cross-over design

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: May 7, 2020
• Study Start: January 1, 2021
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CH (1)