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OpenTrials
Completed

NCT Number: NCT04379401

Acute Impact of Cardiac Resynchronization on Vascular Function (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Flicker-light induced vasodilatation of retinal arterioles assessed by retinal vessel analyzer (RVA)

    Time frame: A single study 1 day visit is planned.

    Difference in flicker-light induced vasodilatation of retinal arterioles between biventricular pacing of the CRT switched ON and OFF.

Sponsors and collaborators

Lead sponsor

Andreas Flammer

Other

Registry information

Acronym: RVA-CRT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 7, 2020
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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