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

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Cardiac Resynchronization Therapy (ON vs. OFF)

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

UniversitätsSpital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Biventricular Pacing deactivated

Biventricular Pacing activated

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04379401

First Posted

January 30, 2020

Last Updated

July 31, 2023

Sponsor

Andreas Flammer

1. Study Identification

Unique Protocol Identification Number

NCT04379401

Brief Title

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

Acronym

RVA-CRT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

June 20, 2023 (Actual)

Study Completion Date

June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andreas Flammer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biventricular Pacing deactivated

Arm Type

Other

Arm Description

Arm Title

Biventricular Pacing activated

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Cardiac Resynchronization Therapy (ON vs. OFF)

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Time Frame

A single study 1 day visit is planned.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas J Flammer, MD

Organizational Affiliation

University of Zurich

Official's Role

Principal Investigator

Facility Information:

Facility Name

UniversitätsSpital Zürich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

It is not yet decided in what way there will be data sharing.

Learn more about this trial

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

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