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Trial record 30 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

Effect of Beta-blocker Therapy on QTc Response in Exercise and Recovery in Normal Subjects

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ClinicalTrials.gov Identifier: NCT00588965
Recruitment Status : Completed
First Posted : January 9, 2008
Results First Posted : July 30, 2013
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
Elizabeth S. Kaufman, MD, MetroHealth Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Conditions Long QT Syndrome
Cardiac Repolarization
Interventions Drug: Placebo
Drug: Propranolol LA
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description All participants were randomized to one of 2 sequences, in which they received either propranolol first, then placebo, or placebo first, then propranolol.
Period Title: Overall Study
Started 35
Completed 35
Not Completed 0
Arm/Group Title All Subjects
Hide Arm/Group Description Subjects will take propranolol LA 80 mg or placebo daily for one week then propranolol LA 160 mg for one week or 2 placebo pills, followed by the exercise test. The participants will be randomized to one of 2 sequences: placebo first or propranolol first.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
35
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
32  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
20
  57.1%
Male
15
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title QTc Response to Exercise on Versus Off Beta-blocker.
Hide Description To minimize the effect of heart rate on QT, QT was measured at heart rates between 100 and 110 beats per minute during exercise (on and off beta-blocker) and during recovery (on and off beta-blocker).
Time Frame 2 weeks on each treatment then exercise test
Hide Outcome Measure Data
Hide Analysis Population Description
Please note that this was a crossover study. There were 35 subjects and each subject completed both the placebo and beta-blocker arm.
Arm/Group Title Placebo Propranolol
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: ms
During exercise 320  (17) 317  (16)
During recovery 317  (13) 315  (14)
2.Secondary Outcome
Title Tpeak-end Interval (Tpe)
Hide Description Tpeak-end interval was measured at rest, exercise, and recovery on placebo and on propranolol.
Time Frame Measured after 2 weeks on each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Propranolol
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: ms
Rest 74  (13) 72  (13)
Peak Exercise 69  (13) 61  (11)
Recovery 77  (19) 68  (14)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Propranolol
Hide Arm/Group Description Subjects are assigned to placebo. Subjects will take propranolol LA 80 mg daily for one week then 160 mg for one week followed by the exercise test.
All-Cause Mortality
Placebo Propranolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Propranolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Propranolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Elizabeth Kaufman
Organization: MetroHealth Medical Center
Phone: 216-778-2349
Responsible Party: Elizabeth S. Kaufman, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00588965     History of Changes
Other Study ID Numbers: IRB07-00418
NIH grant, GCRC MO1 RR000080
First Submitted: December 26, 2007
First Posted: January 9, 2008
Results First Submitted: May 1, 2012
Results First Posted: July 30, 2013
Last Update Posted: July 30, 2013