Left Ventricular Hypertrophy Clinical Trial
— SPECOfficial title:
"Surveillance of Postnatal Steroids Effects on Cardiac Function in Extremely Preterm Infants With Evolving BPD: the SPEC Study."
NCT number | NCT04644094 |
Other study ID # | 2021-7305 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 15, 2021 |
Est. completion date | June 2025 |
Hypothesis/Study question In infants born at less than 29 weeks of estimated gestational age, what are the effects of dexamethasone use on cardiac structure/performance and lung water content? Study objectives To measure effects before and after dexamethasone administration on cardiac structure/performance will be evaluated by using the M-mode technique (Devereux method (25-27) and lung water content will be specifically determined by the degree of water retention in premature lungs assessed by lung ultrasound at the pre specified time points. Methodology / Study design Single center, prospective observational cohort study planning to enroll eligible patients over a period of 12 months
Status | Recruiting |
Enrollment | 21 |
Est. completion date | June 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Minute and older |
Eligibility | Inclusion Criteria: - < 29 weeks of gestational age at birth admitted at the McGill University Children Hospital's neonatal intensive care unit - To be initiated on dexamethasone therapy for treatment of significant lung disease as per medical team decision. Exclusion Criteria: - Congenital heart disease (except: Atrial septum defect (ASD), Ventricular septum defect (VSD) - Major congenital anomalies/genetic disorder (Trisomy 13, 18, 21) - Congenital severe lung or airway malformation (Trachea-esophageal fistula, congenital pulmonary airway malformation, congenital diaphragmatic hernia) - Twin-twin transfusion syndrome |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Children's hospital, Mcgill University Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores) | The effects of dexamethasone administration on cardiac structure/performance will be evaluated by using the M-mode technique (Devereux method (25-27)
0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Primary | Lung water content | Lung water content will be specifically determined by the degree of water retention in premature lungs assessed by lung ultrasound at the specified time points:
0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | Left ventricular (LV) output | The effects of dexamethasone administration on:
On the LV output assessed by Doppler by echocardiography Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | LV and RV function by strain | LV and RV function by strain by post treatment of echocardiography acquired images with a Tomtec platform
Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | LV ejection fraction | The effects of dexamethasone administration on:
The ejection fraction measured by Simpson on a echocardiography. Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | Ductal size | The effects of dexamethasone administration on the size patent ductus arteriosus (PDA) measured on the echocardiography
Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | Doppler flow velocities | The effects of dexamethasone administration on:
The Doppler flow velocities measured by echocardiography Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | Measures of PDA significance | The effects of dexamethasone administration on:
LA:AO (left atrium: aorta) Resistance index (RI) of the Anterior Cerebral Artery Direction of ductal flow Peak velocity of PDA in systole Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | LV mass by STE | LV mass calculation using Speckle tracking echocardiography (STE) on the Tomtec platform
Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | RV function by TAPSE | The effects of dexamethasone administration on:
Tricuspid annular plane systolic excursion measurement by M-Mode on the echocardiography Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | Strain and 3D values | The effects of dexamethasone administration on:
RV and LV strains and on the cardiac volumes by 3 D (RV and LV) by echocardiography acquired images, using Tomtec platform for post treatment Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | Heart rate variability | The effects of dexamethasone administration on heart rate variability by ECG
Time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer |
At the time of echocardiography | |
Secondary | Growth trajectory | The effects of dexamethasone administration on growth trajectory (body, length, head circumference, L/W ratio) at 1-,2-weekks prior treatment and 1-,2-,3-,4-,6-,8- weeks after treatment, and finally at 36 weeks PMA | At the time of the last echocardiography | |
Secondary | Cortisol levels | The effects of dexamethasone after administration:
Cortisol levels in nmol/L |
At the study completion (12 months) | |
Secondary | BPD | The effects of dexamethasone administration on:
-BPD rate (%) (2018 NICHD definition) |
At the study completion (12 months) | |
Secondary | Mortality | - Rate of death in this high risk population (%) | At the study completion (12 months) | |
Secondary | Responders and non responders to Dexamethasone | We will analyze the rate (%) of responders and non-responders to Dexamethasone. Responders: Defined by decreasing Respiratory Severity Scores (RSS) by 40% at day 6 of Dexamethasone treatment or before. RSS is calculated by using maximum of mean airway pressure (MAP) multiplied by fractional oxygen (FiO2) at the day of the first dose of Dexamethasone administration (Day 0) | At the study completion (12 months) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Completed |
NCT03332745 -
Mechanism of Decompensation Evaluation - Aortic Stenosis
|
||
Completed |
NCT03322319 -
Frequency of Cardiac Amyloidosis in the Caribbean's. (TEAM Amylose)
|
N/A | |
Completed |
NCT01951404 -
Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study
|
Phase 4 | |
Terminated |
NCT01188369 -
Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
|
Phase 4 | |
Completed |
NCT00344903 -
Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort
|
N/A | |
Completed |
NCT00518479 -
Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression
|
N/A | |
Completed |
NCT00001632 -
Investigation Into the Use of Ultrasound Technique in the Evaluation of Heart Disease
|
N/A | |
Completed |
NCT00001534 -
Long Term Effects of Enalapril and Losartan on Genetic Heart Disease
|
N/A | |
Suspended |
NCT03193073 -
Anemia Correction and Fibroblast Growth Factor 23 Levels in Chronic Kidney Disease , and Renal Transplant Patient
|
N/A | |
Enrolling by invitation |
NCT05903313 -
A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
|
||
Recruiting |
NCT05646056 -
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
|
||
Completed |
NCT01455974 -
The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients
|
N/A | |
Active, not recruiting |
NCT00418041 -
Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study)
|
N/A | |
Completed |
NCT00602004 -
Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan
|
N/A | |
Completed |
NCT00219141 -
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
|
Phase 3 | |
Completed |
NCT03666351 -
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
|
Phase 4 | |
Recruiting |
NCT05730309 -
Point-of-care Ultrasound and Treatment Disparities for Left Ventricular Hypertrophy
|
N/A | |
Not yet recruiting |
NCT04022330 -
Protective Monocytes and Macrophages to Limit Decompensation and Heart Damaging
|
N/A | |
Recruiting |
NCT06169358 -
Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy
|