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Hemodynamic Response of Neuropathic And Non-Neuropathic POTS Patients To Adrenoreceptor Agonist And Antagonist

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ClinicalTrials.gov Identifier: NCT03070730
Recruitment Status : Terminated (Recruitment was slow and subjects declined participation after signing the ICF.)
First Posted : March 6, 2017
Results First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roy Freeman, MD, Beth Israel Deaconess Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Postural Orthostatic Tachycardia Syndrome
Orthostatic Intolerance
Interventions: Drug: Droxidopa
Drug: Atenolol
Drug: Placebos

  Participant Flow

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
Participants that were enrolled in the study were excluded from the study because they either did not meet eligibility criteria or decided not to participate.

Reporting Groups
  Description
Atenolol

In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.

Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.

Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.

Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d

Atenolol: Atenolol: 50 mg Q.D.

Placebos: Placebo: t.i.d

Placebos

In this arm subjects are randomized to placebo tid.

Placebo is used to control the administration effect.

Placebos: Placebo: t.i.d

Droxidopa

In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.

Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.

Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.

Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d

Atenolol: Atenolol: 50 mg Q.D.

Placebos: Placebo: t.i.d


Participant Flow:   Overall Study
    Atenolol   Placebos   Droxidopa
STARTED   0   0   0 
COMPLETED   0   0   0 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

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.
Participants that were enrolled in the study were not randomized. They did not meet eligibility criteria, or decided not to participate.

Reporting Groups
  Description
Atenolol

In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.

Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.

Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.

Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d

Atenolol: Atenolol: 50 mg Q.D.

Placebos: Placebo: t.i.d

Placebos

In this arm subjects are randomized to placebo tid.

Placebo is used to control the administration effect.

Placebos: Placebo: t.i.d

Droxidopa

In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.

Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.

Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.

Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d

Atenolol: Atenolol: 50 mg Q.D.

Placebos: Placebo: t.i.d

Total Total of all reporting groups

Baseline Measures
   Atenolol   Placebos   Droxidopa   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0   0 
Age, Customized   0   0   0    
Sex: Female, Male         
Female   0   0   0    
Male   0   0   0    
Race (NIH/OMB)         
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   0   0   0   0 
White   0   0   0   0 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 


  Outcome Measures

1.  Primary:   Change in Maximal Postural Tachycardia During Tilt   [ Time Frame: Up to 3 days after randomization ]

2.  Primary:   Change Maximal Postural Tachycardia During Tilt   [ Time Frame: 2 weeks after first intervention ]

3.  Primary:   Change Maximal Postural Tachycardia During Tilt   [ Time Frame: 2 weeks after second intervention ]

4.  Primary:   Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline   [ Time Frame: up to 3 days after randomization ]

5.  Primary:   Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline   [ Time Frame: 2 weeks after first intervention ]

6.  Primary:   Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline   [ Time Frame: 2 weeks after second intervention ]

7.  Secondary:   Change in Blood Pressure From Baseline   [ Time Frame: 1 week after first intervention ]

8.  Secondary:   Change in Blood Pressure From Baseline   [ Time Frame: 1 week after second intervention ]

9.  Secondary:   Change in Blood Pressure From Baseline   [ Time Frame: 1 week after third intervention ]

10.  Secondary:   Change in Heart Rate From Baseline   [ Time Frame: 1 week after first intervention ]

11.  Secondary:   Change in Heart Rate From Baseline   [ Time Frame: 1 week after second intervention ]

12.  Secondary:   Change in Heart Rate From Baseline   [ Time Frame: 1 week after third intervention ]

13.  Secondary:   Change in Vascular Resistance From Baseline   [ Time Frame: 1 week after first intervention ]

14.  Secondary:   Change in Vascular Resistance From Baseline   [ Time Frame: 1 week after second intervention ]

15.  Secondary:   Change in Vascular Resistance From Baseline   [ Time Frame: 1 week after third intervention ]

16.  Secondary:   Change in Muscle Sympathetic Nerve Activity From Baseline   [ Time Frame: 1 week after first intervention ]

17.  Secondary:   Change in Muscle Sympathetic Nerve Activity From Baseline   [ Time Frame: 1 week after second intervention ]

18.  Secondary:   Change in Muscle Sympathetic Nerve Activity From Baseline   [ Time Frame: 1 week after third intervention ]

19.  Secondary:   Change in Physical Functioning-SF-36 Q From Baseline   [ Time Frame: 1 week after first intervention ]

20.  Secondary:   Change in Physical Functioning-SF-36 Q From Baseline   [ Time Frame: 1 week after second intervention ]

21.  Secondary:   Change in Physical Functioning-SF-36 Q From Baseline   [ Time Frame: 1 week after third intervention ]

22.  Secondary:   Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline   [ Time Frame: 1 week after first intervention ]

23.  Secondary:   Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline   [ Time Frame: 1 week after second intervention ]

24.  Secondary:   Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline   [ Time Frame: 1 week after third intervention ]

25.  Secondary:   Change in Physical Functioning- HADS From Baseline   [ Time Frame: 1 week after first intervention ]

26.  Secondary:   Change in Physical Functioning- HADS From Baseline   [ Time Frame: 1 week after second intervention ]

27.  Secondary:   Change in Physical Functioning- HADS From Baseline   [ Time Frame: 1 week after third intervention ]

28.  Secondary:   Change in Physical Functioning-CIS From Baseline   [ Time Frame: 1 week after first intervention ]

29.  Secondary:   Change in Physical Functioning-CIS From Baseline   [ Time Frame: 1 week after second intervention ]

30.  Secondary:   Change in Physical Functioning-CIS From Baseline   [ Time Frame: 1 week after third intervention ]

31.  Secondary:   Change in Physical Functioning-MFI From Baseline   [ Time Frame: 1 week after first intervention ]

32.  Secondary:   Change in Physical Functioning-MFI From Baseline   [ Time Frame: 1 week after second intervention ]

33.  Secondary:   Change in Physical Functioning-MFI From Baseline   [ Time Frame: 1 week after third intervention ]

34.  Secondary:   Change in Physical Functioning-FSS From Baseline   [ Time Frame: 1 week after first intervention ]

35.  Secondary:   Change in Physical Functioning-FSS From Baseline   [ Time Frame: 1 week after second intervention ]

36.  Secondary:   Change in Physical Functioning-FSS From Baseline   [ Time Frame: 1 week after third intervention ]

37.  Secondary:   Change in Physical Functioning-EuroQOL From Baseline   [ Time Frame: 1 week after first intervention ]

38.  Secondary:   Change in Physical Functioning-EuroQOL From Baseline   [ Time Frame: 1 week after second intervention ]

39.  Secondary:   Change in Physical Functioning-EuroQOL From Baseline   [ Time Frame: 1 week after third intervention ]

40.  Secondary:   Change in Physical Functioning-OI From Baseline   [ Time Frame: 1 week after first intervention ]

41.  Secondary:   Change in Physical Functioning-OI From Baseline   [ Time Frame: 1 week after second intervention ]

42.  Secondary:   Change in Physical Functioning-OI From Baseline   [ Time Frame: 1 week after third intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
The trial was terminated early due to difficulties in the recruitment process. Subjects were found to be ineligible, or decided not to participate in the study.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Roy Freeman
Organization: Beth Israel Deaconess Medical Center
phone: 617-632-8454
e-mail: rfreeman@bidmc.harvard.edu


Publications:


Responsible Party: Roy Freeman, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03070730     History of Changes
Other Study ID Numbers: 2011P000246
R01HL059459 ( U.S. NIH Grant/Contract )
First Submitted: February 27, 2012
First Posted: March 6, 2017
Results First Submitted: April 12, 2017
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017