RecruitingNot ApplicableNCT05993585

The Effect of CRT on the Frank Starling Mechanism

The Effects of Cardiac Resynchronisation Therapy on the Frank Starling Mechanism in Patients With Heart Failure


Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrollment

40 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators are examining a scientific principle called the Frank Starling Mechanism and how it relates to Cardiac Resynchronisation Therapy (CRT), a form of pacemaker therapy used in the treatment of heart failure. The Frank Starling Mechanism is an established biological principle. The law states that the stroke volume of the heart increases in response to an increase in the volume of blood in the ventricles, before contraction, when all other factors remain constant. In other words, the law states that the more blood enters the heart, the more blood is pumped out of the heart with any given beat. There is some evidence that in some patients with chronic heart conditions, the Frank Starling Mechanism is LESS EFFECTIVE, meaning that the heart is less able to cope with a reduction in heart pumping function over time. There is also evidence that treatment with CRT may IMPROVE the Frank Starling Mechanism - evidence for this has been shown in dog and mice hearts, however, has never been shown in humans. The investigators aim to conduct a study where subjects undergo an ultrasound scan of the heart (echocardiogram) whilst the participants pacemaker settings are temporarily changed. This allows the investigators to measure the pumping function of the heart as more blood enters the heart. The investigators will perform this test on 20 participants before and after CRT, as well as 20 participants who have pacemakers, but no heart failure. This study aims to test 3 hypotheses. 1. In participants with pacemakers, a REDUCED Frank Starling Mechanism predicts which participants go on to develop heart failure. 2. Treatment with CRT IMPROVES the Frank Starling Mechanism in participants with pacemakers and heart failure. 3. The degree of improvement of the Frank Starling Mechanism after treatment with CRT predicts which participants will respond to this treatment.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • • Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
  • Existing dual chamber pacemaker or ICD including atrial lead and RV lead.
  • RV pacing percentage \>40%.
  • CRT group - Severe left ventricular systolic impairment (LVEF≤35%). Clinical symptoms of heart failure despite optimum medical therapy (NYHA class II-IV).
  • Control group - LVEF \>50%.

Exclusion Criteria4

  • • Previous treated with CRT (existing LV lead/His-Bundle lead/Left Bundle Branch Area lead).
  • Persistent atrial fibrillation
  • Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
  • Participation in other studies with active treatment / investigational arm

Interventions

OTHERTest Of The Frank Starling Mechanism - Adjustment Of Av Delay And Measurement Of Pre-load -Control

(Control Group): One test of the Starling mechanism Visit 1: Sign consent form, doctor assessment, electrocardiogram (ECG), Starling Test. If patients are in this category, this will be their only research visit

OTHEROther: Test Of The Frank Starling Mechanism - Adjustment Of Av Delay And Measurement Of Pre-load -CRT

(CRT Group): Two tests of the Starling mechanisms Visit 1: Sign consent form, assessment by doctor, electrocardiogram (ECG), Test of the Starling mechanism Visit 2: CRT upgrade procedure - your Cardiologist will explain this procedure to you. Visit 3: CRT pacing check at 6 weeks post-procedure Visit 4: Assessment by doctor, ECG, Echocardiogram, Test of the Starling mechanism at 6 months post-procedure.


Locations(1)

Guy's and St Thomas' NHS Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05993585


Related Trials