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Paced Dyssynchrony and Myocardial Perfusion IN apiCal Hcm

NCT04231032 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-04-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Asynchronous dual chamber pacing (DOO) with paced ventricular activation

Alteration of the participant's existing pacemaker mode to either paced or intrinsic ventricular activation (in an order based upon randomisation).

OTHER

Asynchronous atrial pacing (AOO) with intrinsic ventricular activation

Alteration of the participant's existing pacemaker mode to either paced or intrinsic ventricular activation (in an order based upon randomisation).

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Saidi A Mohiddin, MBChBFRCPMD · Barts & The London NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2023-02-20
Completion
2023-02-20

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231032 on ClinicalTrials.gov