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PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy (The POSEIDON-DCM Study) (PoseidonDCM)

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.
 
ClinicalTrials.gov Identifier: NCT01392625
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Non-ischemic Dilated Cardiomyopathy
Interventions Biological: Autologous hMSCs
Biological: Allogeneic hMSCs
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Autologous hMSCs Allogeneic hMSCs
Hide Arm/Group Description

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Period Title: Overall Study
Started 18 19
Completed 16 18
Not Completed 2 1
Arm/Group Title Autologous hMSCs Allogeneic hMSCs Total
Hide Arm/Group Description

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Total of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 37 participants
57.4  (11.0) 54.4  (11.5) 55.8  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
7
  38.9%
5
  26.3%
12
  32.4%
Male
11
  61.1%
14
  73.7%
25
  67.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Hispanic or Latino
8
  44.4%
4
  21.1%
12
  32.4%
Not Hispanic or Latino
10
  55.6%
15
  78.9%
25
  67.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.6%
2
  10.5%
3
   8.1%
White
16
  88.9%
17
  89.5%
33
  89.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.6%
0
   0.0%
1
   2.7%
Participants Injection status in the trial  
Measure Type: Count of Participants
Unit of measure:  Participants
No Number Analyzed 18 participants 19 participants 37 participants
2
  11.1%
1
   5.3%
3
   8.1%
Yes Number Analyzed 18 participants 19 participants 37 participants
16
  88.9%
18
  94.7%
34
  91.9%
Participants Ejection Fraction % in the trial  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 18 participants 19 participants 37 participants
21.7  (6.2) 22.5  (6.5) 22.1  (6.3)
Enrollment End Diastolic diameter (CM)  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 18 participants 19 participants 37 participants
7.0  (1.6) 7.2  (1.2) 7.1  (1.4)
New York Heart Association Class   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
Class I - no limitation
6
  37.5%
4
  22.2%
10
  29.4%
Class II - Slight Limitation of Physical Activity
8
  50.0%
9
  50.0%
17
  50.0%
Class III - Marked Limitation of Physical Activity
2
  12.5%
5
  27.8%
7
  20.6%
Class IV -Inability to carry on physical activity
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
1.Primary Outcome
Title Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)
Hide Description Incidence of TE-SAEs is defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or any other potential late effects detected and corroborated by clinical presentation, laboratory investigations, image analysis and when necessary with biopsy from suspected target sites in the body.
Time Frame One month post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous hMSCs Allogeneic hMSCs
Hide Arm/Group Description:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Overall Number of Participants Analyzed 16 18
Measure Type: Count of Participants
Unit of Measure: Participants
Upper respiratory tract infection
1
   6.3%
0
   0.0%
Ventricular tachycardia
0
   0.0%
1
   5.6%
Device Pacing issue
0
   0.0%
1
   5.6%
2.Secondary Outcome
Title Measurement of Changes in Peak VO2
Hide Description Measurement of Peak oxygen consumption (Peak VO2) by treadmill determination during the 12 month follow-up period.
Time Frame Baseline, 6 month and 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous hMSCs Allogeneic hMSCs
Hide Arm/Group Description:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Overall Number of Participants Analyzed 16 18
Mean (Standard Deviation)
Unit of Measure: ml/kg/min
Peak VO2 (Baseline) 16.0  (5.13) 17.9  (5.17)
Peak VO2 (6 months) 15.5  (6.62) 17.6  (3.55)
Peak VO2 (1 year) 16.4  (3.92) 20.1  (5.10)
3.Secondary Outcome
Title Measurement of Changes in 6 Minute Walk
Hide Description Measurement of Six-minute walk test during the 12 month follow-up period
Time Frame Baseline, 6 month and 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous hMSCs Allogeneic hMSCs
Hide Arm/Group Description:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Overall Number of Participants Analyzed 16 18
Mean (Standard Deviation)
Unit of Measure: meters
6 minute walk (Baseline) 416.4  (105.74) 427.2  (67.35)
6 minute walk (6 months) 384.2  (106.96) 438.7  (106.53)
6 minute walk (1 year) 32.3  (12.71) 35.1  (13.59)
4.Secondary Outcome
Title Measurement of Changes in Global Ejection Fraction
Hide Description Measurement of regional left ventricular function, end diastolic and end systolic volume, measured by MRI, and or CT, and echocardiogram.
Time Frame Baseline, 6 month and 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous hMSCs Allogeneic hMSCs
Hide Arm/Group Description:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Overall Number of Participants Analyzed 16 18
Mean (Standard Deviation)
Unit of Measure: % ratio of the SV to Global EDV
Global ejection fraction (Baseline) 25.2  (10.49) 37.6  (9.03)
Global ejection fraction (1 year) 32.3  (12.71) 35.1  (13.59)
5.Secondary Outcome
Title Measurement of Changes in New York Heart Association (NYHA)
Hide Description Measurement of New York Heart Association (NYHA) functional class during the 12 month follow-up period.
Time Frame Baseline, 6 month and 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous hMSCs Allogeneic hMSCs
Hide Arm/Group Description:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Overall Number of Participants Analyzed 18 19
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Class 1 (Baseline)
6
  33.3%
4
  21.1%
NYHA Class 2 (Baseline)
8
  44.4%
9
  47.4%
NYHA Class 3 (Baseline)
2
  11.1%
5
  26.3%
NYHA Class 1 (6 month)
8
  44.4%
12
  63.2%
NYHA Class 2 (6 month)
6
  33.3%
4
  21.1%
NYHA Class 3 (6 month)
1
   5.6%
1
   5.3%
NYHA Class 1 (12 month)
7
  38.9%
14
  73.7%
NYHA Class 2 (12 month)
2
  11.1%
1
   5.3%
NYHA Class 3 (12 month)
2
  11.1%
0
   0.0%
6.Secondary Outcome
Title Measurement of Changes in Minnesota Living With Heart Failure (MLHF) Questionnaire
Hide Description Measurement of Minnesota Living with Heart Failure (MLHF) Questionnaire during the 12 month follow-up period. It measures the effects of symptoms, functional limitations, and psychological distress on an individual's quality of life. The response scale for all 21 items on the MLHF is based on a 6-point. The Maximum possible scores being 126 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life.
Time Frame Baseline, 6 month and 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous hMSCs Allogeneic hMSCs
Hide Arm/Group Description:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Overall Number of Participants Analyzed 16 18
Median (Full Range)
Unit of Measure: scores on a scale
MLHF (Baseline)
30.5
(5.0 to 80.0)
38.0
(10.0 to 82.0)
MLHF (6 month)
35
(0.0 to 87.0)
18
(0.0 to 68.0)
MLHF (12 month)
9.0
(0.0 to 41.0)
12.0
(0.0 to 51.0)
Time Frame These AE's were collected over a period of 1 year from the subject signing the consent form.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Autologous hMSCs Allogeneic hMSCs
Hide Arm/Group Description

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

All-Cause Mortality
Autologous hMSCs Allogeneic hMSCs
Affected / at Risk (%) Affected / at Risk (%)
Total   2/18 (11.11%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Autologous hMSCs Allogeneic hMSCs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/18 (33.33%)      6/19 (31.58%)    
Cardiac disorders     
Ventricular tachycardia  [1]  0/18 (0.00%)  0 1/19 (5.26%)  1
Arrhythmia  [2]  0/18 (0.00%)  0 1/19 (5.26%)  1
Cardiac failure  [2]  2/18 (11.11%)  3 1/19 (5.26%)  1
Coronary artery disease  [2]  1/18 (5.56%)  1 0/19 (0.00%)  0
Ventricular tachycardia  [2]  0/18 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders     
Gatrooesophageal reflux disease  [2]  0/18 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations     
Upper respiratory tract infection  [1]  1/18 (5.56%)  1 0/19 (0.00%)  0
Upper respiratory tract infection  [2]  1/18 (5.56%)  1 0/19 (0.00%)  0
Injury, poisoning and procedural complications     
Subdural heamatoma  [2]  1/18 (5.56%)  1 0/19 (0.00%)  0
Nervous system disorders     
Syncope  [2]  1/18 (5.56%)  1 0/19 (0.00%)  0
Product Issues     
Device Pacing issue  [1]  0/18 (0.00%)  0 1/19 (5.26%)  1
Device pacing issues  [2]  0/18 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  [2]  0/18 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders     
Angioedema  [2]  0/18 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
[1]
1-month SAE
[2]
6-month SAE
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Autologous hMSCs Allogeneic hMSCs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/18 (22.22%)      7/19 (36.84%)    
Blood and lymphatic system disorders     
Anemia  [1]  0/18 (0.00%)  0 1/19 (5.26%)  1
Cardiac disorders     
Mitral valve incompetence  [2]  1/18 (5.56%)  1 0/19 (0.00%)  0
Ventricular tachycardia  [3]  0/18 (0.00%)  0 1/19 (5.26%)  1
General disorders     
Adverse drug reaction  [3]  0/18 (0.00%)  0 1/19 (5.26%)  1
Chest Discomfort  [3]  0/18 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations     
Upper respiratory tract infection  [3]  1/18 (5.56%)  1 1/19 (5.26%)  1
Vulvovaginal mycotic infection  [3]  0/18 (0.00%)  0 1/19 (5.26%)  1
Investigations     
Electrocardiogram abnormal  [3]  0/18 (0.00%)  0 1/19 (5.26%)  1
Weight increased  [3]  2/18 (11.11%)  2 0/19 (0.00%)  0
Nervous system disorders     
Dizziness  [3]  0/18 (0.00%)  0 1/19 (5.26%)  1
Migraine  [3]  0/18 (0.00%)  0 1/19 (5.26%)  1
Product Issues     
Device pacing issue  [3]  0/18 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  [3]  1/18 (5.56%)  1 0/19 (0.00%)  0
Wheezing  [3]  1/18 (5.56%)  1 0/19 (0.00%)  0
Surgical and medical procedures     
Implantable defibrillator insertion  [3]  0/18 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
[1]
Treatment Emergent Adverse event at one-month
[2]
Treatment Emergent AE at 1-month
[3]
Treatment emergent adverse event at 1 month
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joshua M. Hare, MD
Organization: ISCI / University of Miami Miller School of Medicine
Phone: 305-243-5579
EMail: JHare@med.miami.edu
Publications:
Layout table for additonal information
Responsible Party: Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier: NCT01392625     History of Changes
Other Study ID Numbers: 20100968
1R01HL110737-01 ( U.S. NIH Grant/Contract )
First Submitted: June 29, 2011
First Posted: July 12, 2011
Results First Submitted: August 3, 2017
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018