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Clinical Trials/NCT04379401
NCT04379401
Completed
N/A

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

Andreas Flammer1 site in 1 country35 target enrollmentJanuary 1, 2021
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Andreas Flammer
Enrollment
35
Locations
1
Primary Endpoint
Flicker-light induced vasodilatation of retinal arterioles assessed by retinal vessel analyzer (RVA)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
June 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Andreas Flammer
Responsible Party
Sponsor Investigator
Principal Investigator

Andreas Flammer

PD Dr. med. Andreas Flammer

University of Zurich

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
  • 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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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