Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-27 @ 8:14 AM
Study NCT ID:
NCT04231032
Status:
TERMINATED
Last Update Posted:
2023-04-06
First Post:
2020-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paced Dyssynchrony and Myocardial Perfusion IN apiCal Hcm
Sponsor:
Barts & The London NHS Trust
Organization:
Study Overview
Official Title:
Paced Dyssynchrony and Myocardial Perfusion IN apiCal Hcm
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit to target
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PINCHcm
Brief Summary:
Hypertrophic cardiomyopathy (HCM) is the most common inherited heart disease. A relatively common subgroup of HCM patients have apical HCM - a type of heart muscle disease that causes abnormal muscle thickening towards the tip (apex) of the heart. This can impair the heart's own blood flow through the thickened heart muscle. We think this is one of the causes for symptoms such as shortness of breath and chest pain. If medications are ineffective at treating symptoms, there are few further options available, limited to invasive heart surgery.
This study aims to determine if it is possible to improve the blood flow within by altering the settings of patients' permanent pacemakers, dynamic microvascular obstruction is an important cause of perfusion abnormalities in HCM and whether introducing localized dyssynchrony with ventricular pacing improves this. This phased study will include patients with apical HCM that already have implanted pacemaker devices to remove risks associated with device implantation.
The study may provide insights into novel mechanisms for symptoms in HCM and provide new methods for treating a patient group in whom therapeutic options can be extremely limited.
This study aims to determine if it is possible to improve the blood flow within by altering the settings of patients' permanent pacemakers, dynamic microvascular obstruction is an important cause of perfusion abnormalities in HCM and whether introducing localized dyssynchrony with ventricular pacing improves this. This phased study will include patients with apical HCM that already have implanted pacemaker devices to remove risks associated with device implantation.
The study may provide insights into novel mechanisms for symptoms in HCM and provide new methods for treating a patient group in whom therapeutic options can be extremely limited.
Detailed Description:
The treatments for people with apical HCM and symptoms are limited but include medicines. The use of a pacemaker in this situation is an experimental treatment which has not yet been fully explored. We believe symptoms are linked with abnormalities in blood flow through the heart muscle at the tip / apex of the heart and wish to see if using a pacemaker can improve such abnormalities. We want to test if this treatment works using a clinical trial to help us decide whether this is a viable treatment option that may be offered to other patients with the condition. The null hypothesis states that there will be no difference in blood flow through the heart muscle with pacing. The alternative hypothesis states that there will be a significant difference in blood flow through the heart muscle with pacing. This was chosen based upon our current knowledge that abnormal blood flow in the heart muscle in apical HCM is linked with abnormal squeeze at the apex / tip and symptoms. Echocardiography pilot data has demonstrated a reduction in squeeze at the apex of the heart when using the pacemaker to cause the heart muscle to contract in a different way.
Our alternative hypothesis therefore is that we can use the pacemaker to reduce squeeze at the apex and improve blood flow through the heart muscle. This is a single centre, prospective pilot study. Because data on acute changes in perfusion with pacing in apical HCM are extremely limited, the most ethical methodology is to perform a two-phase study. Phase A of the study assesses acute changes in blood flow through the heart muscle during different pacemaker settings (active and back-up), looking for potential efficacy of the intervention. Secondary outcomes of Phase A include recruitment rate and proportion of patients willing to proceed to Phase B. Phase B of the study consists of entering those same patients into a randomised double-blind cross-over 6-month follow-up pilot to collect baseline statistical data and assess acceptability of study protocol to design a future study. Here, assessment of further secondary outcomes will allow establishment of baseline statistical data for the design of an outcomes-based clinical trial. Patients will only be entered into phase B of the study if an improvement is seen in myocardial perfusion with pacing during phase A.
Our alternative hypothesis therefore is that we can use the pacemaker to reduce squeeze at the apex and improve blood flow through the heart muscle. This is a single centre, prospective pilot study. Because data on acute changes in perfusion with pacing in apical HCM are extremely limited, the most ethical methodology is to perform a two-phase study. Phase A of the study assesses acute changes in blood flow through the heart muscle during different pacemaker settings (active and back-up), looking for potential efficacy of the intervention. Secondary outcomes of Phase A include recruitment rate and proportion of patients willing to proceed to Phase B. Phase B of the study consists of entering those same patients into a randomised double-blind cross-over 6-month follow-up pilot to collect baseline statistical data and assess acceptability of study protocol to design a future study. Here, assessment of further secondary outcomes will allow establishment of baseline statistical data for the design of an outcomes-based clinical trial. Patients will only be entered into phase B of the study if an improvement is seen in myocardial perfusion with pacing during phase A.
Study Oversight
Has Oversight DMC:
True
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?: