urea and Left Ventricular Dysfunction

urea has been researched along with Left Ventricular Dysfunction in 30 studies

pseudourea: clinical use; structure
isourea : A carboximidic acid that is the imidic acid tautomer of urea, H2NC(=NH)OH, and its hydrocarbyl derivatives.

Research

Studies (30)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20

The effect of treatment on exercise capacity, as assessed by peak oxygen uptake, was assessed during cardiopulmonary exercise testing (CPET) with gas-exchange analysis. Cycle ergometry was the preferred modality for exercise testing; treadmill exercise testing was an acceptable alternative. Participants were to use the same testing modality for all exercise tests during the study. Whenever possible, CPET was administered by the same study personnel using the same equipment throughout the study. (NCT03759392)
Timeframe: Baseline and Week 20

Change in the Average Daily Activity Units Measured Over a 2-week Period From Baseline (Week -2 to Day 1) to Weeks 18-20

The effect of treatment on daily activity, as assessed by average daily activity units, was evaluated by actigraphy. Actigraphy was collected during 4 sessions throughout the study for 2 week intervals. (NCT03759392)
Timeframe: Baseline (Week -2 to Day 1) to Weeks 18-20

Change in Total Workload During Cardiopulmonary Exercise Testing From Baseline to Week 20

Total workload was measured during CPET (cycle ergometry [preferred] or treadmill exercise testing) and represents the maximum load to which a participant was subjected during CPET in order to produce work. (NCT03759392)
Timeframe: Baseline and Week 20

Change in Ventilatory Efficiency During Cardiopulmonary Exercise Testing From Baseline to Week 20

Ventilatory efficiency (ventilation [VE]/volume of exhaled carbon dioxide [VCO2]) was measured through CPET with gas exchange analysis. (NCT03759392)
Timeframe: Baseline and Week 20

Dose Escalation Phase: Area Under the Plasma Concentration-time Curve for a Dosing Interval of 12 Hours Post Dose (AUC12) for Omecamtiv Mecarbil

(NCT01786512)
Timeframe: Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose

Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)

(NCT01786512)
Timeframe: Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose.

Dose Escalation Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing on Day 7

(NCT01786512)
Timeframe: Day 7 at predose

Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)

(NCT01786512)
Timeframe: Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose.

Expansion Phase: Change From Baseline in Heart Rate at Week 20

Heart rate was measured using electrocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates. (NCT01786512)
Timeframe: Baseline and week 20

Expansion Phase: Change From Baseline in Left Ventricular End Diastolic Diameter (LVEDD) at Week 20

LVEDD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates. (NCT01786512)
Timeframe: Baseline and week 20

Expansion Phase: Change From Baseline in Left Ventricular End Systolic Diameter (LVESD) at Week 20

LVESD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates. (NCT01786512)
Timeframe: Baseline and week 20

Expansion Phase: Change From Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP) at Week 20

Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates. (NCT01786512)
Timeframe: Baseline and week 20

Expansion Phase: Change From Baseline in Stroke Volume at Week 20

Stroke volume was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates. (NCT01786512)
Timeframe: Baseline and week 20

Expansion Phase: Change From Baseline in Systolic Ejection Time (SET) at Week 20

Systolic ejection time was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates. (NCT01786512)
Timeframe: Baseline and week 20

Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events

"An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events.~Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE.~A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:~fatal~life threatening~required in-patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event" (NCT01786512)
Timeframe: From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase.

Expansion Phase: Maximum Observed Plasma Concentration of Omecamtiv Mecarbil

(NCT01786512)
Timeframe: Weeks 2 and 12 at predose and 1, 2, 4, 6, and 8 hours post-dose.

Expansion Phase: Number of Participants With Treatment-emergent Adverse Events

"An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events.~Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE.~A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:~fatal~life threatening~required in-patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event" (NCT01786512)
Timeframe: From first dose of study drug until 4 weeks after last dose; treatment duration was 20 weeks in the expansion phase.

Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing

(NCT01786512)
Timeframe: Predose (before morning dose) at weeks 2, 8, 12, 16, and 20

CK-1827452 Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUClast)

Determined by evaluation of plasma concentrations from blood samples collected prior to dosing and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 and 48 hours after initiation of study drug infusion (NCT00624442)
Timeframe: 2 days

CK-1827452 Maximum Observed Plasma Concentration (Cmax)

Determined by evaluation of plasma concentrations from blood samples collected prior to dosing and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 and 48 hours after initiation of study drug infusion (NCT00624442)
Timeframe: 2 days

Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations

Pooled analysis of the echocardiographic measure fractional shortening from echocardiograms taken at all timepoints. Fractional shortening is the percentage of change from baseline in the left ventricular cavity dimension with systole. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452. (NCT00624442)
Timeframe: 4 days

Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations

Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452. (NCT00624442)
Timeframe: 4 days

Reviews

2 reviews available for urea and Left Ventricular Dysfunction

Trials

8 trials available for urea and Left Ventricular Dysfunction

Other Studies

20 other studies available for urea and Left Ventricular Dysfunction