Acute Effects of Benzbromaron on the Pulmonary Circulation | NCT02790450

Studies
Acute Effects of Benzbromaron on the Pulmonary Circulation

NCT02790450

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Dec 23, 2016Estimated

Enrollment

10Actual

Phase

Phase 2

Conditions

Idiopathic Pulmonary Arterial Hypertension

Interventions

Benzbromarone

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

May 30, 2016

First Submission Date that Met QC Criteria

May 30, 2016

First Posted Date

Jun 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2016

Last Update Posted Date

Dec 23, 2016Estimated

Name	Class
Ludwig Boltzmann Institute for Lung Vascular Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Actual studies suggest that a calcium activated chlorid channel (TMEM16A) may play a relevant role in the pathogenesis of pulmonary arterial hypertension (PAH). The inhibition of this channel led to pulmonary vasorelaxation in preclinical studies. Benzbromarone is a well known inhibitor of the TMEM16A channel and is used in patients with gout.

In this pilot study the investigators plan to investigate if Benzbromarone has an acute effect on the pulmonary arteries in humans. This will be investigated within the frame of a right heart catheterization performed in patients with known PAH due to clinical reasons. The investigators hypothesize that the application of Benzbromarone leads to pulmonary vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. In addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge pressure, heart rate and arterial oxygen saturation will be assessed. Due to clinical reasons patients will receive NO (15 ppm) during right heart catheterization. Hemodynamic changes upon NO and Benzbromarone may be compared.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Benzbromarone	Experimental	1x200mg Benzbromarone	Drug: Benzbromarone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Benzbromarone	Drug	1x200mg Benzbromarone will be applied after baseline measurements during right heart catheterization. The effects of the drug on the pulmonary hemodynamics will be assessed after 2 hours.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulmonary vascular resistance (Wood units) assessed by right heart catheterization		2 hours

Secondary Outcomes

Measure	Description	Time Frame
Mean pulmonary arterial pressure (mmHg) assessed by right heart catheterization		2 hours
Mean systemic arterial pressure (mmHg) assessed by sphygmomanometer		2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

written informed consent
known pulmonary arterial hypertension
right heart catheterization indicated due to clinical reasons

Exclusion Criteria:

known allergy against Benzbromaron, Gelborange S or other ingredient of the used drug (Benzbromarone AL) or a drug with similar chemical structure
severe renal insufficiency (GFR<30ml/min/kg)
renal diathesis
severe hepatic disease (Bilirubin >1.6 mg% or AST or ALT > 3x Norm)
known pregnancy
uncontrolled systemic arterial hypertension (>150 mmHg systolic or 95 mmHg diastolic)
uncontrolled ventricular arrythmia
uncontrolled bradycardic or tachycardic supraventricular arrythmia
myocardiac infarction within the last 12 months
pulmonary embolism within the last 6 months
ongoing iv. or sc. Prostanoid therapy for PAH
Pulmonary hypertension other than PAH

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Horst Olschewski, MD	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz		8036	Austria

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065627	Familial Primary Pulmonary Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001553	Benzbromarone

Ancestor Terms

ID	Term
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided