18 and older, any sex, with Hypertrophic Cardiomyopathy or Non-ischemic Dilated Cardiomyopathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Prevalence of Microvascular Dysfunction (MVD) by a CMR Measurement of Whole-heart (Global) Perfusion Reserve Ratio in Patients With Hypertrophic Cardiomyopathy, Non-ischemic Cardiomyopathy, and Controls.Primary· The prevalence of MVD will be determined based on the findings at the time of the scan on Day 1 of the study.
Prevalence of microvascular dysfunction as determined by the CMR measure of global perfusion reserve ratio (GPR) in each these patient groups. MVD was considered present when either GPR was \<2.0 or regional stress perfusion abnormalities were present.
In order to calculate this ratio, coronary sinus flow was measured twice:
1. prior to the the administration of adenosine/regadenoson
2. during the administration of adenosine/regadenoson
GPR is a ratio of coronary sinus flow during the administration adenosine/regadenoson divided by the baseline coronary sinus flow measured prior to the admi
Group
Value
95% CI
Hypertrophic Cardiomyopathy
79
Non-ischemic Dilated Cardiomyopathy
33.3
Control
20
CMR Measurement of Global Perfusion Reserve RatioSecondary· The global perfusion ratio will be calculated from the measurements obtained at the time of the scan on Day 1 of the study.
Comparison of the CMR measure of global perfusion reserve ratio (GPR) in each these patient groups.
In order to calculate this ratio, coronary sinus flow was measured twice:
1. prior to the the administration of adenosine/regadenoson
2. during the administration of adenosine/regadenoson
Group
Value
95% CI
Hypertrophic Cardiomyopathy
2.99
1.87 – 4.65
Non-ischemic Dilated Cardiomyopathy
3.04
2.64 – 3.61
Control
3.83
2.42 – 4.34
The Association Between Global Perfusion Reserve (GPR) Ratio and Regional Myocardial Scarring.Secondary· Both global perfusion ratio and the presence of regional scarring will be determined/measured from the images obtained during the scan on Day 1 of the study.
Relationship between global perfusion reserve ratio and regional myocardial scarring.
Group
Value
95% CI
Hypertrophic Cardiomyopathy - Scarring
3.19
± 1.71
Hypertrophic Cardiomyopathy - Without Scarring
5.91
± 4.09
Non-ischemic Dilated Cardiomyopathy - Scarring
3.16
± 0.65
Control - Without Scarring
3.53
± 1.26
Sponsor's own description
The aim of this study is to assess microvascular function as determined by a cardiovascular magnetic resonance measurement of whole-heart (global) perfusion reserve. The goal is to determine the prevalence of MVD in two common forms of non-ischemic cardiomyopathy, hypertrophic cardiomyopathy (HCM) and idiopathic dilated cardiomyopathy (IDCM). The hypothesis that an optimized technique will provide robust detection of MVD and that a multifaceted approach will provide new insights into the pathophysiology of MVD, including the influence of myocardial scarring upon the presence and severity of MVD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 16 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03249272.