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Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT) (effecT)

This study has been terminated.
(Criterion according study protocol to end study prematurely was fulfilled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00811382
First Posted: December 19, 2008
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biotronik SE & Co. KG
Results First Submitted: December 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Heart Failure (HF)
Atrial Fibrillation
Interventions: Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)
Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1: Access to HMSC

Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC

Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring

2: No Access to HMSC

Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.

Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)


Participant Flow:   Overall Study
    1: Access to HMSC   2: No Access to HMSC
STARTED   88   75 
COMPLETED   88   75 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1: Access to HMSC

Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC.

Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring.

2: No Access to HMSC

Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.

Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity).

Total Total of all reporting groups

Baseline Measures
   1: Access to HMSC   2: No Access to HMSC   Total 
Overall Participants Analyzed 
[Units: Participants]
 88   75   163 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.7  (8.5)   67.3  (10)   68.1  (9.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  23.9%      16  21.3%      37  22.7% 
Male      67  76.1%      59  78.7%      126  77.3% 
Height,centimeter (cm) 
[Units: Cm]
Median (Standard Deviation)
 172  (9)   171  (8)   172  (9) 
Weight, kilogram (kg) 
[Units: Kg]
Mean (Standard Deviation)
 82  (16)   81  (15)   81  (15) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 27.6  (4.4)   27.6  (4.4)   27.6  (4.4) 
New York Heart Association functional class (NYHA class) [1] 
[Units: Participants]
Count of Participants
     
Class I   0   0   0 
Class II   7   5   12 
Class III   75   67   142 
Class IV   6   3   9 
[1]

Class I: No limitation of physical activity.

Class II: Slight limitation of physical activity.

Class III: Marked limitation of physical activity, but comfortable at rest.

Class IV: Unable to carry on any physical activity without discomfort and symptoms of heart failure at rest.

This classification is not an outcome but a patient characteristic at enrollment. From the given explanation, it is obvious that lower classes are better.

Cardiomyopathy 
[Units: Participants]
     
Ischemic   49   40   89 
Non-ischemic   39   35   74 
Left ventricular ejection fraction (LVEF) [1] 
[Units: Percentage %]
Median (Standard Deviation)
 27  (7)   26  (7)   27  (7) 
[1]

The Left ventricular ejection fraction (EF) is always reported in the unit of percentage (%). It is the ratio of pumped blood volume divided by the maximal filling volume. The EF refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction.

An EF of 27 percent means that 27 percent of the total amount of blood in the left ventricle is pushed out with each heartbeat.

Left Ventricular End-Systolic Volume (LVESV) 
[Units: Ml]
Median (Standard Deviation)
 135  (58)   159  (70)   146  (64) 
Left atrial diameter (LAD) 
[Units: Mm]
Mean (Standard Deviation)
 49  (10)   48  (8)   48  (9) 
Mitral regurgitation [1] 
[Units: Participants]
Count of Participants
     
Mild   38   39   77 
Moderate   28   15   43 
Severe   3   2   5 
No regurgitation   17   17   34 
not reported   2   2   4 
[1] A definition of the severity of Mitral Regurgitation can not be given, because the study did enforce a specific one and physicians used their standard definitions. It is not possible to describe their meaning for laypersons better that with the term used (mild, moderate, severe)
History of VT/VF 
[Units: Patients]
     
Patients with VT/VF   22   15   37 
Patients with No VT/VF   66   60   126 
QRS duration 
[Units: Ms]
Median (Standard Deviation)
 158  (24)   159  (26)   158  (25) 
Heart Rate 
[Units: Beats/min]
Mean (Standard Deviation)
 71  (14)   68  (16)   70  (15) 
AV (atrioventricular) Block [1] 
[Units: Patients]
     
No relevant finding   36   32   68 
First Degree   23   17   40 
Second Degree   2   3   5 
Third Degree   9   4   13 
Other   18   19   37 
[1]

The classification of atrioventricular block as 1st, 2nd and 3rd degree follows the standard textbook definition. It is not possible to describe their meaning for laypersons.

This classification is not outcome but a patient characteristic at enrollment. A lower grade is better.

Rhythm at enrollment [1] 
[Units: Patients]
     
Sinus Rhythm   75   66   141 
AF   4   6   10 
Other   9   3   12 
[1] Sinus Rhythm: with heart rate in the normal range of 60 – 100 beats/min AF: generally at a rate between 110 and 180 beats/min.
Non-CV (cardiovascular) Morbidity at Enrollment [1] 
[Units: Patients]
     
Diabetes mellitus   35   20   55 
Renal insufficiency   15   10   25 
COPD   18   13   31 
Thyroid disease   15   9   24 
Hepatic disease   2   1   3 
Mental disorder   4   2   6 
Other   28   19   47 
[1] the sum of participants in all categories for the measure does not equal the overall number of baseline participants due to the fact that patients have sometimes more than 1 non-cv morbidity at enrollment
History of AF 
[Units: Patients]
     
Paroxysmal   60   47   107 
Persistent   21   19   40 
no History of AF   7   9   16 
Ventricular Rate during AF 
[Units: Beats/min]
Mean (Standard Deviation)
 104  (33)   100  (32)   102  (33) 
Days since AF is known 
[Units: Days]
Mean (Standard Deviation)
 1222  (2076)   644  (930)   974  (1701) 
History of pharmacological cardioversion 
[Units: Patients]
     
successful   15   9   24 
not successful   5   3   8 
not tried   61   54   115 
not reported   7   9   16 
History of electrical cardioversion 
[Units: Patients]
     
successful   30   24   54 
not successful   1   0   1 
not tried   50   42   92 
not reported   7   9   16 
History of atrial ablation 
[Units: Patients]
     
successful ablation   0   0   0 
partly successful   3   3   6 
not successful   3   1   4 
not tried   75   62   137 
not reported   7   9   16 
History AV node ablation 
[Units: Patients]
     
successful   0   1   1 
not successful   1   0   1 
not tried   80   65   145 
not reported   7   9   16 
AF treatment at enrollment [1] 
[Units: Patients]
     
Rate control   16   14   30 
Rhythm control   47   37   84 
No AF treatment   21   17   38 
not reported   4   7   11 
[1] some patients underwent both rate control and rhythm control
Medication at Enrollment 
[Units: Patients]
     
ACE inhibitor or ARB   72   63   135 
Amiodarone   36   36   72 
Beta blocker   69   63   132 
Calcium channel blocker   5   3   8 
Digitalis   13   6   19 
Sotalol   5   2   7 
Other antiarrhythmic   1   1   2 
Anticoagulants   61   54   115 
Antiplatelet   39   25   64 
Lipid-lowering drug   63   47   110 
Nitrate   7   4   11 
Spironolactone   42   28   70 
Other diuretic   72   63   135 
Other medication   23   21   44 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Days Lost   [ Time Frame: 12 months ]

2.  Secondary:   Heart Failure Clinical Composite Score (Packer Score)   [ Time Frame: 12 months ]

3.  Secondary:   Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)   [ Time Frame: 12 months ]

4.  Secondary:   Progression of AF and AT/AF Burden   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the disappointing enrollment speed, it has been decided to discontinue the study. Therefore, the study is not powered to test the planned hypothesis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mathias Freudigmann
Organization: BIOTRONIK
phone: +49(0)30 68905 - 1248
e-mail: mathias.freudigmann@biotronik.com



Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00811382     History of Changes
Other Study ID Numbers: HS044
First Submitted: December 18, 2008
First Posted: December 19, 2008
Results First Submitted: December 5, 2016
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017