urea and Cardiac Failure

urea has been researched along with Cardiac Failure in 199 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 (199)

Authors

Clinical Trials (12)

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.

Change in 6 Minute Walk Distance

Change in 6 minute walk distance baseline to 180 days. (NCT01800968)
Timeframe: Baseline to 180 days

Change in 6 Minute Walk Distance

Change in 6 minute walk distance baseline to 90 days. (NCT01800968)
Timeframe: Baseline to 90 days

Change in 6 Minute Walk Distance

Change in 6 minute walk distance baseline to day 30 (NCT01800968)
Timeframe: Baseline to day 30

Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 30 days

Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 90 days

Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to day 180

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 30 days

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 90 days

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.

Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 180 days

Change in Lateral Filling Pressure

Change in lateral filling pressure baseline to day 180. (NCT01800968)
Timeframe: Baseline to 180 days

Change in Left Ventricular Ejection Fraction

Change in left ventricular ejection fraction from baseline to day 180 (NCT01800968)
Timeframe: Baseline to 180 days

Change in Left Ventricular End-Diastolic Volume Index

Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days. (NCT01800968)
Timeframe: Baseline to 180 days

Change in Left Ventricular End-systolic Volume Index

Change in left ventricular end-systolic volume index from baseline to day 180. (NCT01800968)
Timeframe: Baseline to 180 days

Change in Medial Filling Pressure

Change in medial filling pressure baseline to day 180. (NCT01800968)
Timeframe: Baseline to 180 days

Global Ranking of Predefined Events

A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size. (NCT01800968)
Timeframe: Randomization to 180 days

Global Ranking of Predefined Events

A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation. (NCT01800968)
Timeframe: Baseline to 180 days

Individual Component of the Primary Endpoint- Heart Failure Hospitalization

Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days (NCT01800968)
Timeframe: Randomization to 180 days

Individual Component of the Primary Endpoint- Mortality

Individual component of the primary endpoint of mortality at 180 days after randomization (NCT01800968)
Timeframe: Randomization to 180 days

Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP

Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days (NCT01800968)
Timeframe: Baseline to 180 days

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.