Pulmonary Arterial HypertensionPhase 1/2NCT00964678

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

A Phase 1/2 study testing Carvedilol in people with Pulmonary Arterial Hypertension, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: Carvedilol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Jun 2010to May 2014
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23298

Other trials in United States

About this study

Read the 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.

Conditions: Pulmonary Arterial Hypertension
Being tested: Carvedilol
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CarvedilolDrug
Also called Coreg
twice daily oral treatment in escalating dose

Study groups in NCT00964678
Study group	Role	What they receive
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 Receives: Drug: Carvedilol

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: baseline, 6 months

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010May 2014

First posted25 Aug 2009 (estimated)
Study startJun 2010
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00964678
Sponsor's protocol ID: HM12120
Status last verified: Jun 2017
First submitted: 24 Aug 2009
Last updated: 8 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: IPD will not be shared

Publications

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.
PubMed 24930531

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
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All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT00964678
Acronym / sponsor ID: HM12120
Conditions: Pulmonary Arterial Hypertension
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Jun 2010
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 25 Aug 2009 (estimated)
Results: Posted 8 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
carvedilol	Experimental	Drug: CarvedilolCarvedilol 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CarvedilolAlso: Coregtwice daily oral treatment in escalating dose	Drug	carvedilol

Primary outcome

Absolute Change in Right Ventricular Ejection Fraction
Time frame: baseline, 6 months
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

3 secondary outcomes

Change in Right Ventricular End Systolic Volume
Time frame: baseline and 6 months
Change in 6 Minute Walk Distance
Time frame: baseline and 6 months
Change in Tricuspid Annular Plane Systolic Excursion
Time frame: baseline and 6 months

Results and safety

Results posted to the registry on 8 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carvedilol	10	6

Primary outcome: Absolute Change in Right Ventricular Ejection Fraction

Time frame: baseline, 6 months. Mean (95% Confidence Interval). Unit: % RVEF

Measure	Carvedilol n = 6
Value	10.4 (3.6 to 16)

Carvedilol: p = 0.028, ANOVA

Population analysed: Patients with right heart catheterization confirmed pulmonary arterial hypertension, already on pulmonary vasodilator therapy

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carvedilol	0 of 6 (0%)	1 of 6 (16.7%)	Not reported

Limitations and caveats (from the sponsor): Small number of patients enrolled. This study is hypothesis generating and was meant to lead to larger studies of carvedilol in pulmonary hypertension

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24930531Grinnan 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.
Individual participant dataSharing planned: No. IPD will not be shared

Related trials for Pulmonary Arterial Hypertension

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel C Grinnan, M.D principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Carvedilol in people with Pulmonary Arterial Hypertension, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change in Right Ventricular Ejection Fraction (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00964678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.