Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05993585
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-07-31
Brief Title:
The Effect of CRT on the Frank Starling Mechanism
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
The Effects of Cardiac Resynchronisation Therapy on the Frank Starling Mechanism in Patients With Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRT
Brief 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
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
Detailed Description:
The primary research investigation in this study is a non-invasive test of the Frank Starling mechanism which involves performing a transthoracic echocardiogram ultrasound scan of the heart whilst temporarily changing pacemaker settings to mimic conditions such as faster heart rates or increased blood flow to the heart Measurements taken from the echocardiogram during these changes in pacemaker settings will be used to determine the effectiveness of the hearts Starling Mechanism This test will last between 20-40 minutes No special preparation is needed and participants will be able to go home immediately afterwards Pacemaker settings will be returned to normal once the test is completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None