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Trial record 68 of 188 for:    GLYCOPYRROLATE

Chronotropic Incompetence in Patients With HFpEF

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: NCT02524145
Recruitment Status : Completed
First Posted : August 14, 2015
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Levine, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Heart Failure
Interventions Other: Static Handgrip
Drug: Dexmedetomidine
Drug: Glycopyrrolate
Drug: Isoproterenol
Enrollment 40
Recruitment Details Recruitment initiated in June 2015 and completed October 2017. Subjects were recruited from academic medical center cardiology clinic. Healthy control subjects were recruited from the community.
Pre-assignment Details  
Arm/Group Title Healthy Seniors HFpEF Healthy Young
Hide Arm/Group Description

Fifteen healthy senior volunteers > 60 years of age. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Patients with HFpEF will provide data from their cardiologist or primary care physician that confirm the following: a) signs and symptoms of heart failure; b) an ejection fraction > 0.50; and c) objective evidence of diastolic dysfunction.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Fifteen volunteers <45 yrs will be enrolled. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins and have BMI <30.

Intervention: Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Period Title: Overall Study
Started 15 15 10
Completed 13 13 7
Not Completed 2 2 3
Reason Not Completed
Withdrawal by Subject             2             2             3
Arm/Group Title Healthy Seniors HFpEF Healthy Young Total
Hide Arm/Group Description

Fifteen healthy senior volunteers > 60 years of age. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Patients with HFpEF will provide data from their cardiologist or primary care physician that confirm the following: a) signs and symptoms of heart failure; b) an ejection fraction > 0.50; and c) objective evidence of diastolic dysfunction.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Fifteen volunteers <45 yrs will be enrolled. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins and have BMI <30.

Intervention: Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 10 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 10 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
   6.7%
6
  40.0%
10
 100.0%
17
  42.5%
>=65 years
14
  93.3%
9
  60.0%
0
   0.0%
23
  57.5%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 7 participants 33 participants
71  (4) 68  (6) 31  (4) 61  (17)
[1]
Measure Analysis Population Description: Two senior controls, three young controls and two HFpEF subjects withdrew consent.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 7 participants 33 participants
Female
6
  46.2%
7
  53.8%
1
  14.3%
14
  42.4%
Male
7
  53.8%
6
  46.2%
6
  85.7%
19
  57.6%
[1]
Measure Analysis Population Description: Two senior controls, three young controls and two HFpEF subjects withdrew consent.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 7 participants 33 participants
Hispanic or Latino
0
   0.0%
1
   7.7%
1
  14.3%
2
   6.1%
Not Hispanic or Latino
13
 100.0%
12
  92.3%
6
  85.7%
31
  93.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Two senior controls, three young controls and two HFpEF subjects withdrew consent.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 7 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
2
  28.6%
2
   6.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.7%
2
  15.4%
1
  14.3%
4
  12.1%
White
12
  92.3%
11
  84.6%
4
  57.1%
27
  81.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Two senior controls, three young controls and two HFpEF subjects withdrew consent.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 10 participants 40 participants
15 15 10 40
Exercise heart rate   [1] 
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 13 participants 13 participants 7 participants 33 participants
156  (15) 117  (15) 190  (8) 148  (32)
[1]
Measure Analysis Population Description: Two senior control, three young control and two HFPEF subjects withdrew after consent.
Beta-receptor function   [1] 
Mean (Standard Deviation)
Unit of measure:  Beats per ng/kg/min
Number Analyzed 13 participants 13 participants 7 participants 33 participants
0.254  (0.166) 0.156  (0.133) 0.365  (0.129) 0.239  (0.163)
[1]
Measure Analysis Population Description: Two senior controls, three young controls and two HFpEF subjects withdrew consent
1.Primary Outcome
Title Cardiac Beta-receptor Sensitivity
Hide Description Cardiac beta-receptor sensitivity will be measured by calculating slope of heart rate versus isoproterenol serum level.
Time Frame 1 day; primary outcome was complete for each subject in 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Seniors HFpEF Healthy Young
Hide Arm/Group Description:

Fifteen healthy senior volunteers > 60 years of age. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins. All control subjects will have a Body Mass Index (BMI) <30, with exercise histories of less than 3 days per week of aerobic exercise.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Patients with HFpEF will provide data from their cardiologist or primary care physician that confirm the following: a) signs and symptoms of heart failure; b) an ejection fraction > 0.50; and c) objective evidence of diastolic dysfunction.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Fifteen volunteers <45 yrs will be enrolled. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins and have BMI <30.

Intervention: Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Overall Number of Participants Analyzed 13 13 7
Mean (Standard Deviation)
Unit of Measure: beats per ng/kg/min ISO
0.254  (0.166) 0.156  (0.133) 0.365  (0.129)
2.Primary Outcome
Title Central Command Regulation of Heart Rate
Hide Description Heart rate response to static hand grip immediately followed by supra-systolic arm occlusion and release will determine adequacy on central command control over heart rate response during exercise.
Time Frame 1 day; primary outcome was complete for each subject in 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Young subjects did not perform handgrip portion of the study.
Arm/Group Title Healthy Seniors HFpEF
Hide Arm/Group Description:

Fifteen healthy senior volunteers > 60 years of age. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins. All control subjects will have a Body Mass Index (BMI) <30, with exercise histories of less than 3 days per week of aerobic exercise.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Patients with HFpEF will provide data from their cardiologist or primary care physician that confirm the following: a) signs and symptoms of heart failure; b) an ejection fraction > 0.50; and c) objective evidence of diastolic dysfunction.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: beats per minute
93  (11) 89  (14)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Seniors HFpEF Healthy Young
Hide Arm/Group Description

Fifteen healthy senior volunteers > 60 years of age. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins. All control subjects will have a Body Mass Index (BMI) <30, with exercise histories of less than 3 days per week of aerobic exercise.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Patients with HFpEF will provide data from their cardiologist or primary care physician that confirm the following: a) signs and symptoms of heart failure; b) an ejection fraction > 0.50; and c) objective evidence of diastolic dysfunction.

Intervention: Static handgrip and Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Static Handgrip: Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

Fifteen volunteers <45 yrs will be enrolled. Subjects will be healthy with no chronic medical problems and on no cardiac medications except for statins and have BMI <30.

Intervention: Autonomic Blockade (Dexmedetomidine, Glycopyrrolate, Isoproterenol)

Autonomic Blockade: Subjects will be given dexmedetomidine and glycopyrrolate to suppress neural control over heart rate during isoproterenol infusion.

All-Cause Mortality
Healthy Seniors HFpEF Healthy Young
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Seniors HFpEF Healthy Young
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Seniors HFpEF Healthy Young
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/7 (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
Layout table for Results Point of Contact information
Name/Title: Dr. Satyam Sarma
Organization: University of Texas Southwestern Medical Center
Phone: 214-345-7111
EMail: SatyamSarma2@texashealth.org
Layout table for additonal information
Responsible Party: Benjamin Levine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02524145     History of Changes
Other Study ID Numbers: UTexasSouthwestern
First Submitted: August 10, 2015
First Posted: August 14, 2015
Results First Submitted: December 18, 2018
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019