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Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carvedilol
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • idiopathic, familial or associated PAH, WHO group 1
  • NYHA class II or III
  • clinically stable with optimized PAH treatment for at least 3 months
  • no or minimal evidence of fluid overload or volume depletion, with or without diuretic treatment
  • age > 18 years
  • mean pulmonary artery pressure (mPAP) > 25 mmHg
  • 6 minute walk distance (6MWD) over 100m

Exclusion Criteria:

  • Structural heart disease unrelated to PAH
  • Recent (<3 months) treatment with an intravenous positive inotropic agent
  • current use of β-blockers
  • history of reactive airways disease
  • history of adverse reaction to β-blockers
  • heart block on ECG or resting heart rate < 60 bpm
  • cardiac index < 1.8 l/min/m2
  • systemic hypotension (systolic pressure < 90 mmHg)
  • pulmonary capillary wedge pressure > 15 mmHg
  • inability to give informed consent
  • contraindications to CT and/or PET scanning
  • coagulopathy (INR>1.5 or platelet count<50000/mm3)
  • severe renal insufficiency (creatinine clearance <30 ml/min/m2)
  • malignancy or any co-morbidity limiting survival or conditions predicting inability to complete the study.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

carvedilol

Arm Description

Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI

Outcomes

Primary Outcome Measures

Absolute Change in Right Ventricular Ejection Fraction
Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only

Secondary Outcome Measures

Change in Right Ventricular End Systolic Volume
right ventricular end systolic volume determined by MRI
Change in 6 Minute Walk Distance
Change in Tricuspid Annular Plane Systolic Excursion
Higher values indicate a better outcome.

Full Information

First Posted
August 24, 2009
Last Updated
June 6, 2017
Sponsor
Virginia Commonwealth University
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00964678
Brief Title
Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
Official Title
Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether carvedilol treatment of patients with pulmonary arterial hypertension and associated right heart failure is safe and results in an improved function of the right heart.
Detailed Description
Patients with pulmonary arterial hypertension (PAH) will be treated with carvedilol for 24 weeks. During this time, carvedilol will be titrated from an initial dose of 3.125mg BID to a maximal dose of 25mg BID. At the start and end of the study, we will obtain cardiac MRI, 6 minute walk distance, brain natriuretic peptide (serum), echocardiogram, and functional class assessment. Our primary outcome is a change in right ventricular ejection fraction with cardiac MRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carvedilol
Arm Type
Experimental
Arm Description
Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
Coreg
Intervention Description
twice daily oral treatment in escalating dose
Primary Outcome Measure Information:
Title
Absolute Change in Right Ventricular Ejection Fraction
Description
Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in Right Ventricular End Systolic Volume
Description
right ventricular end systolic volume determined by MRI
Time Frame
baseline and 6 months
Title
Change in 6 Minute Walk Distance
Time Frame
baseline and 6 months
Title
Change in Tricuspid Annular Plane Systolic Excursion
Description
Higher values indicate a better outcome.
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: idiopathic, familial or associated PAH, WHO group 1 NYHA class II or III clinically stable with optimized PAH treatment for at least 3 months no or minimal evidence of fluid overload or volume depletion, with or without diuretic treatment age > 18 years mean pulmonary artery pressure (mPAP) > 25 mmHg 6 minute walk distance (6MWD) over 100m Exclusion Criteria: Structural heart disease unrelated to PAH Recent (<3 months) treatment with an intravenous positive inotropic agent current use of β-blockers history of reactive airways disease history of adverse reaction to β-blockers heart block on ECG or resting heart rate < 60 bpm cardiac index < 1.8 l/min/m2 systemic hypotension (systolic pressure < 90 mmHg) pulmonary capillary wedge pressure > 15 mmHg inability to give informed consent contraindications to CT and/or PET scanning coagulopathy (INR>1.5 or platelet count<50000/mm3) severe renal insufficiency (creatinine clearance <30 ml/min/m2) malignancy or any co-morbidity limiting survival or conditions predicting inability to complete the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C Grinnan, M.D
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared
Citations:
PubMed Identifier
24930531
Citation
Grinnan D, Bogaard HJ, Grizzard J, Van Tassell B, Abbate A, DeWilde C, Priday A, Voelkel NF. Treatment of group I pulmonary arterial hypertension with carvedilol is safe. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1562-4. doi: 10.1164/rccm.201311-2025LE. No abstract available.
Results Reference
derived

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Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension

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