PARTNERS HF: Program to Access and Review Trending Inform... | NCT00279955

Status Module

Name	Class
Medtronic	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Resynchronization Therapy Device	Device	Patients with an ICD indication, a CRT indication and symptomatic heart failure who are implanted with a Cardiac Resynchronization Therapy Device.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of Heart Failure (HF) Related Adverse Event (AE)	Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.	From 6 month to the 12 month visit

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)	Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.

Eligibility Module

Name	Affiliation	Role
David Whellan, MD	Jefferson Heart Institute	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20413029	Derived	Whellan DJ, Ousdigian KT, Al-Khatib SM, Pu W, Sarkar S, Porter CB, Pavri BB, O'Connor CM; PARTNERS Study Investigators. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. J Am Coll Cardiol. 2010 Apr 27;55(17):1803-10. doi: 10.1016/j.jacc.2009.11.089.
19061695

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	At Least 1 OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	At Least 1 OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
BG001	No OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
BG002	No OptiVol Measurement	All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00068.8± 11.0 BG00168.2± 10.6 BG00268.5± 11.0 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00045 BG001163 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000157 BG001486 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Occurrence of Heart Failure (HF) Related Adverse Event (AE)

Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.

Of the 1001 subjects meeting inclusion and exclusion criteria, 643 subjects had been followed longer than 6 months and had the OptiVolTM feature save-to-disk data available. Those 643 subjects were included in this analysis.

Posted

Number

participants

From 6 month to the 12 month visit

ID	Title	Description
OG000	At Least 1 OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
OG001	No OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.

Units	Counts
Participants	OG000157 OG001486

Title

Denominators

Categories

Title	Measurements
	OG00029 OG00150

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		0.0119		Cox Proportional Hazard	2.07	Standard Deviation	0.292	2-Sided	95	1.17	3.67			The estimated parameter in a Cox regression model was adjusted by age, gender, New York Heart Association (NYHA) class at 6 month visit, Angiotensin Converting Enzyme (ACE)/Angiotensin Receptor Blocker (ARB) at 6 months, and Diuretics at 6 month.	No	Superiority or Other

Secondary

Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)

Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.

Posted

Number

participants

6 month to the 12 month visit

ID	Title	Description
OG000	At Least 1 OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
OG001	No OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.

Secondary

Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)

Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.

Posted

Number

participants

6 month to the 12 month visit

ID	Title	Description
OG000	At Least 1 OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
OG001	No OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	At Least 1 OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	84	157	75	157
EG001	No OptiVol Fluid Index > 100 During DREP	All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	114	486	172	486
EG002	No OptiVol Measurement	All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.	99	358	96	358

Serious Adverse Events

Term	Organ System	Statistical Information
Atrial fibrillation	General disorders	EG0002 events2 affected157 at risk EG00111 events10 affected486 at risk EG0024 events4 affected358 at risk
Atrial flutter	General disorders	EG0001 events1 affected157 at risk EG0016 events5 affected486 at risk EG0021 events1 affected358 at risk
Atrial tachycardia	General disorders	EG0000 events0 affected157 at risk EG0010 events0 affected486 at risk EG0022 events2 affected358 at risk
Cardiomyopathy	General disorders	EG0000 events0 affected157 at risk EG0010 events0 affected486 at risk EG0022 events2 affected358 at risk
Chest pressure/tightness	General disorders	EG0000 events0 affected157 at risk EG0013 events3 affected486 at risk EG0023 events3 affected358 at risk
Chronic obstructive pulmonary disease	General disorders	EG0001 events1 affected157 at risk EG0013 events3 affected486 at risk EG0020 events0 affected358 at risk
Dehydration	General disorders	EG0000 events0 affected157 at risk EG0013 events3 affected486 at risk EG0021 events1 affected358 at risk
Dizziness	General disorders	EG0000 events0 affected157 at risk EG0012 events2 affected486 at risk EG0022 events2 affected358 at risk
Dyspnea/Shortness of breath	General disorders	EG00017 events12 affected157 at risk EG00129 events21 affected486 at risk EG00221 events18 affected358 at risk
Fatigue, tiredness	General disorders	EG0001 events1 affected157 at risk EG0011 events1 affected486 at risk EG0021 events1 affected358 at risk
Heart failure decompensation	General disorders	EG00035 events24 affected157 at risk EG00124 events22 affected486 at risk EG00230 events24 affected358 at risk
Hypertension	General disorders	EG0000 events0 affected157 at risk EG0012 events1 affected486 at risk EG0020 events0 affected358 at risk
Hypotension	General disorders	EG0003 events3 affected157 at risk EG0014 events4 affected486 at risk EG0021 events1 affected358 at risk
Ischemic heart disease	General disorders	EG0000 events0 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Near (pre) syncope	General disorders	EG0001 events1 affected157 at risk EG0010 events0 affected486 at risk EG0021 events1 affected358 at risk
PVC's	General disorders	EG0000 events0 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Paroxysymal nocturnal dyspnea	General disorders	EG0000 events0 affected157 at risk EG0010 events0 affected486 at risk EG0020 events0 affected358 at risk
Pericardial effusion	General disorders	EG0001 events1 affected157 at risk EG0013 events3 affected486 at risk EG0020 events0 affected358 at risk
Peripheral edema	General disorders	EG0000 events0 affected157 at risk EG0010 events0 affected486 at risk EG0024 events4 affected358 at risk
Peripheral vascular disease	Vascular disorders	EG0000 events0 affected157 at risk EG0010 events0 affected486 at risk EG0023 events3 affected358 at risk
Pleural effusion	General disorders	EG0001 events1 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Pulmonary embolism	General disorders	EG0002 events2 affected157 at risk EG0011 events1 affected486 at risk EG0022 events2 affected358 at risk
Renal failure	General disorders	EG0001 events1 affected157 at risk EG0010 events0 affected486 at risk EG0021 events1 affected358 at risk
Shoulder pain/discomfort	General disorders	EG0002 events1 affected157 at risk EG0010 events0 affected486 at risk EG0020 events0 affected358 at risk
Syncope	General disorders	EG0001 events1 affected157 at risk EG0014 events4 affected486 at risk EG0022 events2 affected358 at risk
Thrombosis	General disorders	EG0001 events1 affected157 at risk EG0012 events2 affected486 at risk EG0021 events1 affected358 at risk
Vascular heart disease	Vascular disorders	EG0000 events0 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Ventricular fibrillation	Cardiac disorders	EG0001 events1 affected157 at risk EG0010 events0 affected486 at risk EG0022 events2 affected358 at risk
Ventricular tachycardia	General disorders	EG0006 events5 affected157 at risk EG0019 events8 affected486 at risk EG0022 events2 affected358 at risk
Wheezing	General disorders	EG0000 events0 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Worsening cough	General disorders	EG0001 events1 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
xOther Intrinsic Rhythm/Conduction Codes	General disorders	EG0001 events1 affected157 at risk EG0011 events1 affected486 at risk EG0021 events1 affected358 at risk
yOther patient disease/condition codes	General disorders	EG0000 events0 affected157 at risk EG0011 events1 affected486 at risk EG0023 events2 affected358 at risk
zAll "Other" codes	General disorders	EG00027 events23 affected157 at risk EG00114 events13 affected486 at risk EG00219 events19 affected358 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Arm/hand swelling	General disorders	EG0000 events0 affected157 at risk EG0012 events2 affected486 at risk EG0021 events1 affected358 at risk
Atrial fibrillation	General disorders	EG0005 events3 affected157 at risk EG0016 events6 affected486 at risk EG0026 events6 affected358 at risk
Atrial flutter	General disorders	EG0000 events0 affected157 at risk EG0013 events3 affected486 at risk EG0022 events2 affected358 at risk
Atrial tachycardia	General disorders	EG0000 events0 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Cardiomyopathy	General disorders	EG0000 events0 affected157 at risk EG0010 events0 affected486 at risk EG0021 events1 affected358 at risk
Chest pressure/tightness	General disorders	EG0000 events0 affected157 at risk EG0015 events3 affected486 at risk EG0021 events1 affected358 at risk
Chronic obstructive pulmonary disease	General disorders	EG0002 events2 affected157 at risk EG0013 events2 affected486 at risk EG0021 events1 affected358 at risk
Dehydration	General disorders	EG0001 events1 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Dizziness	General disorders	EG0004 events4 affected157 at risk EG00112 events12 affected486 at risk EG0028 events4 affected358 at risk
Dyspnea/Shortness of breath	General disorders	EG00030 events23 affected157 at risk EG00143 events39 affected486 at risk EG00223 events19 affected358 at risk
Fatigue, tiredness	General disorders	EG0003 events3 affected157 at risk EG00116 events16 affected486 at risk EG0023 events3 affected358 at risk
Heart failure decompensation	General disorders	EG0007 events6 affected157 at risk EG0018 events8 affected486 at risk EG0026 events4 affected358 at risk
Hypertension	General disorders	EG0001 events1 affected157 at risk EG0010 events0 affected486 at risk EG0021 events1 affected358 at risk
Hypokalemia	General disorders	EG0000 events0 affected157 at risk EG0010 events0 affected486 at risk EG0022 events2 affected358 at risk
Hypotension	General disorders	EG0003 events3 affected157 at risk EG0012 events2 affected486 at risk EG0024 events4 affected358 at risk
Near (pre) syncope	General disorders	EG0002 events2 affected157 at risk EG0013 events2 affected486 at risk EG0023 events3 affected358 at risk
PVC's	General disorders	EG0000 events0 affected157 at risk EG0012 events2 affected486 at risk EG0020 events0 affected358 at risk
Palpitations	General disorders	EG0001 events1 affected157 at risk EG0015 events5 affected486 at risk EG0021 events1 affected358 at risk
Paroxysymal nocturnal dyspnea	General disorders	EG0003 events1 affected157 at risk EG0014 events4 affected486 at risk EG0021 events1 affected358 at risk
Pericardial effusion	General disorders	EG0001 events1 affected157 at risk EG0010 events0 affected486 at risk EG0020 events0 affected358 at risk
Peripheral edema	General disorders	EG0007 events6 affected157 at risk EG00120 events16 affected486 at risk EG00210 events10 affected358 at risk
Peripheral vascular disease	General disorders	EG0000 events0 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Pleural effusion	General disorders	EG0000 events0 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Rash	General disorders	EG0000 events0 affected157 at risk EG0010 events0 affected486 at risk EG0021 events1 affected358 at risk
Syncope	General disorders	EG0000 events0 affected157 at risk EG0017 events7 affected486 at risk EG0022 events2 affected358 at risk
Thrombosis	General disorders	EG0001 events1 affected157 at risk EG0011 events1 affected486 at risk EG0020 events0 affected358 at risk
Ventricular fibrillation	General disorders	EG0000 events0 affected157 at risk EG0017 events7 affected486 at risk EG0025 events5 affected358 at risk
Ventricular tachycardia	General disorders	EG0002 events2 affected157 at risk EG0018 events3 affected486 at risk EG0029 events6 affected358 at risk
Wheezing	General disorders	EG0001 events1 affected157 at risk EG0012 events2 affected486 at risk EG0020 events0 affected358 at risk
xOther Intrinsic Rhythm/Conduction Codes	General disorders	EG0001 events1 affected157 at risk EG0011 events1 affected486 at risk EG0022 events2 affected358 at risk
yOther Patient Disease/Conduction Codes	General disorders	EG0001 events1 affected157 at risk EG0018 events8 affected486 at risk EG0024 events4 affected358 at risk
zAll "Other" Codes	General disorders	EG00019 events12 affected157 at risk EG00120 events17 affected486 at risk EG00217 events12 affected358 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama		United States

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D010138	Pacemaker, Artificial
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies