urea and Heart Failure, Systolic

urea has been researched along with Heart Failure, Systolic in 23 studies

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

Heart Failure, Systolic: Heart failure caused by abnormal myocardial contraction during SYSTOLE leading to defective cardiac emptying.

Research

Studies (23)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24

"The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire with a 2-week recall period that includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score. Scores are represented on a 0-to-100-point scale, where lower scores represent more frequent and severe symptoms and scores of 100 indicate no symptoms.~The change from baseline in KCCQ TSS was analyzed separately for each randomization setting (inpatient and outpatient).~Least squares means are from the mixed model which includes baseline total symptom score value, region, baseline eGFR, scheduled visit, treatment group and interaction of treatment with scheduled visit as covariates." (NCT02929329)
Timeframe: Baseline and Week 24

Time to All-cause Death

"All events were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.~Time to all-cause death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with an event are reported. Events that occurred up to the earliest of last confirmed survival status date or analysis cut-off date (07 August 2020) are included." (NCT02929329)
Timeframe: From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Time to Cardiovascular Death

"Cardiovascular death includes acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.~All deaths were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.~Time to cardiovascular death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported." (NCT02929329)
Timeframe: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Time to Cardiovascular Death or First Heart Failure Event

"The primary outcome was a composite of a heart-failure (HF) event or cardiovascular (CV) death, whichever occurred first, in a time-to-event analysis.~A heart-failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for subjectively and objectively worsening heart failure leading to treatment intensification beyond a change in oral diuretic therapy.~All deaths and HF events were adjudicated by an independent external clinical events committee (CEC) at the Duke Clinical Research Institute, using standardized definitions based on the recent American College of Cardiology/American Heart Association (ACC/AHA) standards for endpoint definitions in cardiovascular clinical trials.~Time to cardiovascular death or first HF event was analyzed using Kaplan-Meier (KM) methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported." (NCT02929329)
Timeframe: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Time to First Heart Failure Hospitalization

"A HF hospitalization is defined as an event that met all of the following criteria:~The participant was admitted to the hospital with a primary diagnosis of HF;~The length of stay in the hospital extended for at least 24 hours;~The participant exhibited documented new or worsening symptoms due to HF on presentation;~The participant had objective evidence of new or worsening HF;~The participant received initiation or intensification of treatment specifically for HF, including an intravenous diuretic or vasoactive agent, mechanical or surgical intervention, or mechanical fluid removal.~Events were adjudicated by an independent external CEC at the Duke Clinical Research Institute using standardized definitions based on the ACC/AHA standards for endpoint definitions in CV clinical trials.~Time to first HF hospitalization was analyzed using KM methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event is reported." (NCT02929329)
Timeframe: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

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

4 reviews available for urea and Heart Failure, Systolic

Trials

2 trials available for urea and Heart Failure, Systolic

Other Studies

17 other studies available for urea and Heart Failure, Systolic