NCT00964678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

June 8, 2017

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

3.9 years

First QC Date

August 24, 2009

Results QC Date

December 10, 2015

Last Update Submit

June 6, 2017

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline, 6 months

Secondary Outcomes (3)

  • Change in Right Ventricular End Systolic Volume

    baseline and 6 months

  • Change in 6 Minute Walk Distance

    baseline and 6 months

  • Change in Tricuspid Annular Plane Systolic Excursion

    baseline and 6 months

Study Arms (1)

carvedilol

EXPERIMENTAL

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

Drug: Carvedilol

Interventions

CarvedilolDRUG

twice daily oral treatment in escalating dose

Also known as: Coreg
carvedilol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • minute walk distance (6MWD) over 100m

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • 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.

    PMID: 24930531DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Limitations and Caveats

Small number of patients enrolled. This study is hypothesis generating and was meant to lead to larger studies of carvedilol in pulmonary hypertension

Results Point of Contact

Title
Dan Grinnan, MD
Organization
Virginia Commonwealth University Health System
daniel.grinnan@vcuhealth.org
804-828-9000

Study Officials

  • Daniel C Grinnan, M.D

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

June 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 8, 2017

Results First Posted

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations

US(1)