uracil and Cardiomyopathy, Hypertrophic

uracil has been researched along with Cardiomyopathy, Hypertrophic in 44 studies

2,4-dihydroxypyrimidine: a urinary biomarker for bipolar disorder

Cardiomyopathy, Hypertrophic: A form of CARDIAC MUSCLE disease, characterized by left and/or right ventricular hypertrophy (HYPERTROPHY, LEFT VENTRICULAR; HYPERTROPHY, RIGHT VENTRICULAR), frequent asymmetrical involvement of the HEART SEPTUM, and normal or reduced left ventricular volume. Risk factors include HYPERTENSION; AORTIC STENOSIS; and gene MUTATION; (FAMILIAL HYPERTROPHIC CARDIOMYOPATHY).

Research

Studies (44)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Percentage of Participants Who Experienced at Least One Serious Treatment-emergent Adverse Event (STEAE)

This is the percentage of participants who experienced at least one serious treatment-emergent adverse event (STEAE) (NCT03442764)
Timeframe: From first dose to 8 weeks following last dose (Up to 24 weeks)

Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)

This is the percentage of participants who experienced at least one treatment emergent adverse event (TEAE) (NCT03442764)
Timeframe: From first dose to 8 weeks following last dose (Up to 24 weeks)

Change From Baseline to Week 30 in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a patient reported outcome instrument with minimum score = 0 and maximum score = 100 where higher score indicates better health status. There are no units to the score. The instrument utilizes a recall period of 2 weeks over which patients describe the frequency and severity of their symptoms, their physical and social limitations, and how they perceive their heart failure symptoms to affect their quality of life. The KCCQ clinical summary (KCCQ-CS) score, a prespecified secondary outcome of EXPLORER-HCM, combines the physical limitation and total symptom scores. (NCT03470545)
Timeframe: 30 weeks

Change From Baseline to Week 30 in Participant-reported Severity of HCM Symptoms as Assessed by the HCMSQ Score

The Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ) is a patient reported outcome instrument that is a daily self-administered 11-item questionnaire. The HCMSQ assesses the core symptoms of HCM (tiredness/fatigue, heart palpitations, chest pain, dizziness, and shortness of breath). The Shortness of Breath domain score, a pre-specified secondary outcome of EXPLORER-HCM, assesses the frequency and severity of shortness of breath. The minimum score = 0 and maximum score = 18 where lower score indicates better health status. There are no units to the score. (NCT03470545)
Timeframe: 30 weeks

Change From Baseline to Week 30 in pVO2 as Assessed by CPET

Cardiopulmonary exercise testing (CPET) was performed at baseline and week 30 following a study-specified protocol and peak oxygen consumption (pVO2) was determined by the Cardiovascular Metabolic Disease Research Institute (CMDRI, Palo Alto, CA). Change from baseline was determined as per the study statistical analysis plan and compared between treatment arms. (NCT03470545)
Timeframe: 30 weeks

Changes From Baseline to Week 30 in Post Exercise in LVOT Peak Gradient.

The post-exercise LVOT gradient was measured from echocardiograms obtained at baseline and week 30 following a study-specified exercise protocol and read by the Cardiovascular Imaging Core Laboratory (CICL, Boston MA). Change from baseline was determined as per the study statistical analysis plan and compared between treatment arms. (NCT03470545)
Timeframe: 30 weeks

Percentage of Participants Achieving A Clinical Response

"A positive clinical response (value=YES) is defined as having achieved either an improvement of at least 1.5 mL/kg/min in peak oxygen consumption (pVO2) as determined by cardiopulmonary exercise testing (CPET) and a reduction of one or more class in New York Heart Association (NYHA) functional classification (e.g.I, II, III, or IV) -OR- an improvement of 3.0 mL/kg/min or more in pVO2 with no worsening in NYHA Functional Class." (NCT03470545)
Timeframe: 30 weeks

Proportion of Participants With at Least 1 Class Improvement in NYHA Functional Class From Baseline to Week 30

New York Heart Association (NYHA) functional classification was determined by the principal investigator at baseline and at specified timepoints in the study. At baseline, all subjects were NYHA Class II or III. For the secondary outcome, NYHA class at Week 30 was compared to baseline and the proportion of subjects with an improvement of at least one class was determined, and the difference between treatment groups was analyzed. The proportion was also multiplied by 100 to provide the result as a percent. (NCT03470545)
Timeframe: 30 weeks

Change From Baseline to Week 16 in Cardiac Troponin

A geometric mean ratio was used to assess the change from baseline to week 16 in cardiac troponin. Baseline values are defined as the last non-missing value prior to the first dose of study drug unless specified otherwise. (NCT04349072)
Timeframe: Baseline and week 16

Change From Baseline to Week 16 in Kansas City Cardiomyopathy Questionnaire 23-item Version, Clinical Summary Score (KCCQ-23, CSS)

The KCCQ-23 is a 23-item, self-administered questionnaire that measures the impact of a participant's cardiovascular disease or its treatment on 6 distinct domains using a 2-week recall period: symptoms/signs, physical limitation, quality of life (QoL), social limitations, self-efficacy, and symptom stability. The KCCQ 23 Clinical Summary Score (CSS) is derived from the Total Symptom Score (TSS) and the Physical Limitations (PL) score of the KCCQ 23. The CSS, TSS, and the PL score range from 0 to 100 with higher scores representing less severe symptoms and/or physical limitations. The CSS is a mean of the TSS and the PL score. (NCT04349072)
Timeframe: Baseline and week 16

Change From Baseline to Week 16 in N-Terminal Pro-b-Type Natriuretic Peptide (NT-proBNP)

A geometric mean ratio was used to assess the change from baseline to Week 16 in N-Terminal Pro-b-Type Natriuretic Peptide (NT-proBNP). Baseline values are defined as the last non-missing value prior to the first dose of study drug unless specified otherwise. (NCT04349072)
Timeframe: Baseline and week 16

Change From Baseline to Week 16 in Post-Exercise Left Ventricular Outflow Tract (LVOT) Gradient

Change from baseline to week 16 in post-exercise left ventricular outflow tract (LVOT) gradient. Baseline values are defined as the last non-missing value prior to the first dose of study drug unless specified otherwise. (NCT04349072)
Timeframe: Baseline and week 16

Composite of Decision to Proceed With Septal Reduction Therapy (SRT) and SRT Guideline Eligible at Week 16

"Participants who decided to proceed with SRT or were eligible for SRT at week 16. Participants with missing assessments were classified as meeting the primary endpoint (did not improve).~SRT eligibility using the New York Heart Association Functional Class (NYHA) and left ventricular outflow tract (LVOT) assessments per the 2011 ACCF/AHA guideline clinical and hemodynamic criterion are below:~NYHA Class III or IV/ NYHA Class II with exertion-induced syncope/near syncope, AND~Dynamic LVOT gradient at rest or with provocation >= 50 mmHg.~NYHA Class II at week 16, the following rules will be applied:~NYHA Class II with history of exertional syncope/ syncope at baseline and at W16 is still NYHA Class II, they remain SRT eligible IF their maximal LVOT gradient is ≥ 50mmHg~NYHA Class III/IV at baseline and at W16 has improved to Class II, they are no longer SRT eligible UNLESS they have AE of exertional syncope or pre-syncope during the 16 weeks." (NCT04349072)
Timeframe: Week 16

Number of Participants With at Least One Class Improvement From Baseline in New York Heart Association (NYHA) Class at Week 16

"The NYHA functional classification of heart failure assigns participants to 1 of 4 categories based on the participants symptoms. Baseline values are defined generally as the last available value before the first administration of study drug of analysis interest. Participants with missing NYHA class assessments are treated as no improvement.~Class 1: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class 2: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~Class 3: Marked limitation of physical activity. Comfortable at rest. Less-than ordinary-activity causes fatigue, palpitation, or dyspnea. Class 4: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases." (NCT04349072)
Timeframe: Baseline and week 16

Change in Dyspnea Symptom Score From Baseline to Week 12

The scale name is Dyspnea Numeric Rating Scale (NRS). It is intended to measure how much shortness of breath you have had in the past week. 0 = no shortness of breath and 10 = shortness of breath as the worst possible. (NCT02842242)
Timeframe: Baseline and Week 12

Change in Global Longitudinal Strain (GLS) From Baseline to Week 12

GLS is assessed using echocardiography measures. (NCT02842242)
Timeframe: Baseline and Week 12

Change in LV Fractional Shortening (LVFS) From Baseline to Week 12

LVFS is assessed using echocardiography measures. (NCT02842242)
Timeframe: Baseline and Week 12

Change in Peak VO2 From Baseline to Week 12

Peak VO2 is assessed using a cardiopulmonary exercise test. (NCT02842242)
Timeframe: Baseline and Week 12

Change in Post-exercise Peak LVOT Gradient From Baseline to Week 12

Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography. (NCT02842242)
Timeframe: Baseline and Week 12

Change in Post-exercise Peak LVOT Gradient From Week 12 to Week 16

Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography. (NCT02842242)
Timeframe: Weeks 12 and 16

Change in Resting LVEF From Baseline to Week 12

LVEF is assessed by echocardiography. (NCT02842242)
Timeframe: Baseline and Week 12

Change in VE/VCO2 From Baseline to Week 12

VE/VCO2 is assessed from cardiopulmonary exercise testing results. (NCT02842242)
Timeframe: Baseline and Week 12

Number of Participants Achieving a Post-exercise Peak LVOT Gradient Response of < 30 mmHg. Gradient < 30 mmHg

LVOT gradients are assessed after a treadmill stress test by echocardiography. (NCT02842242)
Timeframe: Baseline and Week 12

Reviews

7 reviews available for uracil and Cardiomyopathy, Hypertrophic

Trials

8 trials available for uracil and Cardiomyopathy, Hypertrophic

Other Studies

29 other studies available for uracil and Cardiomyopathy, Hypertrophic