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PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol) (PAHTCH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01586156
First Posted: April 26, 2012
Last Update Posted: November 30, 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.
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Samar Farha, MD, The Cleveland Clinic
Results First Submitted: August 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Hypertension
Interventions: Drug: Carvedilol
Drug: placebo

  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
Low-fixed-dose Carvedilol Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
Placebo Arm

Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.

Carvedilol placebo: Placebo taken twice daily for 6 months

Escalation-dose Carvedilol Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol

Participant Flow:   Overall Study
    Low-fixed-dose Carvedilol   Placebo Arm   Escalation-dose Carvedilol
STARTED   10   10   10 
COMPLETED   10   9   10 
NOT COMPLETED   0   1   0 
Pregnancy                0                1                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
Low-fixed-dose Carvedilol Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 1 will receive 3.125mg twice daily for six months. This is the low fixed dose Carvedilol
Escalation-dose Carvedilol Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight to the CRU for the first-dose challenge of carvedilol. Subjects will take the medication for one week and at the end of one week, eligible subjects will be randomized to one of two groups (blinded). Group 2 will receive carvedilol in a dose escalation scheme. They will be given 3.125mg tablets to take twice daily for one week, followed by 6.25 mg twice daily for one week, followed by 12.5mg twice daily for one week with the option to increase to the max dose of 25mg twice daily for the remainder of the study. This is the escalating dose Carvedilol
Placebo Arm

Eligible subjects will receive open label carvedilol therapy at a dose 3.125 mg twice daily for one week. Subjects will be admitted overnight for the first-dose challenge of carvedilol. After one week run in phase, subjects will be placed on placebo. Subjects and Investigators will be blinded to the group assignment for the duration of the study.

Carvedilol placebo: Placebo taken twice daily for 6 months

Total Total of all reporting groups

Baseline Measures
   Low-fixed-dose Carvedilol   Escalation-dose Carvedilol   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   10   30 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      10 100.0%      10 100.0%      30 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42  (6)   53  (9)   38  (14)   42  (4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      7  70.0%      6  60.0%      8  80.0%      21  70.0% 
Male      3  30.0%      4  40.0%      2  20.0%      9  30.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino   0   0   0   0 
Not Hispanic or Latino   10   10   10   30 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1  10.0%      0   0.0%      0   0.0%      1   3.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  20.0%      0   0.0%      4  40.0%      6  20.0% 
White      7  70.0%      10 100.0%      6  60.0%      23  76.7% 
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% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   10   10   10   30 


  Outcome Measures
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1.  Primary:   Cardiac Glucose Uptake in FDG-PET (Fluorodeoxyglucose-Positron Emission Tomography)   [ Time Frame: 6 months ]

2.  Secondary:   Urinary cAMP (Cyclic Adenosine Monophosphate)/Creatinine   [ Time Frame: 6 months ]

3.  Secondary:   Beta-Adrenergic Receptor (Alprenolol Binding Assay)   [ Time Frame: 6 months ]

4.  Other Pre-specified:   Echocardiogram Right Ventricular Systolic Pressure (RVSP)   [ Time Frame: 6 months ]

5.  Other Pre-specified:   6 Minute Walk Test   [ Time Frame: 6 months ]

6.  Other Pre-specified:   NT-proBNP (N-terminal Pro-B Type Natriuretic Peptide)   [ Time Frame: 6 months ]

7.  Other Pre-specified:   Echocardiogram Left Ventricular Cardiac Output   [ Time Frame: 6 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
We thought that there would be a possible limitation of hypotension that might limit dosage


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


Results Point of Contact:  
Name/Title: Dr. Serpil Erzurum
Organization: Cleveland Clinic
phone: 216-445-6624
e-mail: erzurus@ccf.org



Responsible Party: Samar Farha, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01586156     History of Changes
Other Study ID Numbers: 11-1198
R01HL115008 ( U.S. NIH Grant/Contract )
First Submitted: April 23, 2012
First Posted: April 26, 2012
Results First Submitted: August 16, 2017
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017