amiodarone and Heart Failure

amiodarone has been researched along with Heart Failure in 404 studies

Amiodarone: An antianginal and class III antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting POTASSIUM CHANNELS and VOLTAGE-GATED SODIUM CHANNELS. There is a resulting decrease in heart rate and in vascular resistance.
amiodarone : A member of the class of 1-benzofurans that is 1-benzofuran substituted by a butyl group at position 2 and a 4-[2-(diethylamino)ethoxy]-3,5-diiodobenzoyl group at position 3. It is a cardiovascular drug used for the treatment of cardiac dysrhythmias.

Heart Failure: A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.

Research

Studies (404)

Authors

Clinical Trials (42)

Trial Overview

Trial Outcomes

Deaths

Deaths were classified according to the primary cause of death. (NCT01151137)
Timeframe: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Overview of Adverse Events [AE]

AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. (NCT01151137)
Timeframe: from first study drug intake up to 10 days after the last study drug intake

Overview of Cardiovascular Events

(NCT01151137)
Timeframe: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Overview of the Two Co-primary Outcomes

"First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions [MI], or cardiovascular death.~Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause.~Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks [TIA], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause." (NCT01151137)
Timeframe: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Time to Cardiovascular Death (Cumulative Incidence Function)

"Time to cardiovascular death was defined as the time from randomization to the death.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood's variance estimation." (NCT01151137)
Timeframe: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Time to First Co-primary Outcome (Cumulative Incidence Function)

"Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood's variance estimation." (NCT01151137)
Timeframe: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Time to Second Co-primary Outcome (Cumulative Incidence Function)

"Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood's variance estimation." (NCT01151137)
Timeframe: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Adjudicated Cardiovascular Death

The considered event is cardiovascular death, as assessed by the blinded adjudication of the Steering Committee. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period. (NCT00174785)
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 years

Cardiovascular Death

The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period. (NCT00174785)
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 years

Death From Any Cause

The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period. (NCT00174785)
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 years

First Hospitalization for Cardiovascular Reason

The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period. (NCT00174785)
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 years

First Hospitalization for Cardiovascular Reason or Death From Any Cause

The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period. (NCT00174785)
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 years

"Compare First Shock Rate Between Medtronic PainFREE Programming and SCD-HeFT Programming in Primary Prevention Study Participants."

"First shock rate for VF and FVT zones was estimated using Kaplan-Meier method.~OMNI PainFREE definition: programming combinations that result in ATP therapy for ventricular tachycardia (VT) at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.~OMNI SCD-HeFT definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms." (NCT00277524)
Timeframe: 4 years post implant

AV Block Status by Device Type at 6 and 12 Months.

Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants. (NCT00277524)
Timeframe: 12 months post enrollment

AV Block Status by Severity of Historical AV Block

Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block (NCT00277524)
Timeframe: 4 years post implant

Frequencies of Subjects With OptiVol Trends and Disease Progression.

"Estimate the correlation between OptiVol trends and disease progression.~A subject's disease status was said to have progressed if:~The NYHA classification number increases (example: I to II), or~The LVEF decreases by at least 20% (relative difference) and by at least a 5% absolute difference, or~The subject expires~A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'." (NCT00277524)
Timeframe: 4 years post implant

ICD/CRT-D Device Baseline Programming Frequencies

ICD/CRT-D baseline programming, pacing mode and detection. Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost. (NCT00277524)
Timeframe: Baseline

ICD/CRT-D Device Baseline Programming Measurements

"ICD/CRT-D baseline programming measurements, detection interval. Implanted Cardioverter/Defibrillator paces a patient's heart in a tachyarrhythmia prevention-pacing mode.~Detection intervals are used to detect atrial tachyarrhythmia. Detection Intervals are programmable heart rate thresholds. R-R intervals that are less than the VT or VF detection intervals (in ms) are considered evidence of VT or VF, respectively. R-R intervals that are between the FVT and the VF detection intervals are considered evidence of FVT. Thus, these detection interval thresholds demarcate rate zones of detection. The rate zones are used to determine the type of therapy applied once detection occurs." (NCT00277524)
Timeframe: Baseline

Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.

Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost. (NCT00277524)
Timeframe: Baseline

Implanted Systems Frequencies

Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D). (NCT00277524)
Timeframe: Baseline

Summary of ATP Episodes Within All Treated Episodes

Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device. (NCT00277524)
Timeframe: 4 years post enrollment

Cardiovascular Hospitalizations

Records participants hospitalized for VT during the study (NCT01576042)
Timeframe: Baseline, 6 months

Number of Participants Completed Month 3 Follow-Up

Records participants who completed Month 3 Follow-Up Visit (NCT01576042)
Timeframe: 3 months

Number of Participants Completed Month 6 Follow-Up

Records participants who completed Month 6 Follow-Up Visit (NCT01576042)
Timeframe: 6 Months

Number of Participants Had at Least One of the Efficacy Outcome Measurement

Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT) (NCT01576042)
Timeframe: 6 Months

Number of Participants Received Treatment Assigned

Records participants who received study randomized treatment during the study (NCT01576042)
Timeframe: 6 months

Number of Participants Remained on Randomized Treatment Assignment

Records participants who only received study treatment as randomized during the entire study (NCT01576042)
Timeframe: 6 month

Number of Participants Switched to Other Arm

Records participants who received study treatment as randomized and later switched to other treatment arm during the study (NCT01576042)
Timeframe: 6 months

Time to First Recurrent ICD Therapy for VT

Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT. (NCT01576042)
Timeframe: Baseline, 6 months

Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event

"The considered event is the occurrence of the MSE defined as thyroid, hepatic, pulmonary, neurological, skin, eye, or gastrointestinal specific treatment emergent events or premature study drug discontinuation following any adverse event (AE), whichever comes first. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period." (NCT00489736)
Timeframe: minimum study duration is 6 months (+10 days); maximum is 15 months

Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting

"The considered event is the occurrence of the MSE excluding gastrointestinal specific treatment emergent events defined as diarrhoea, nausea, vomiting. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period." (NCT00489736)
Timeframe: minimum study duration is 6 months (+10 days); maximum is 15 months

Treatment Failure

"The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period." (NCT00489736)
Timeframe: minimum study duration is 6 months (+10 days); maximum is 15 months

Reviews

100 reviews available for amiodarone and Heart Failure