The Regulation of Pulmonary Vascular Resistance in Patien... | NCT02275793

Studies
The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure

NCT02275793

Sponsor

University of Toledo Health Science Campus

Status

Completed

Last Update Posted

Sep 18, 2019Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Diastolic Heart Failure
Pulmonary Hypertension

Interventions

Not provided

Countries

United States

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

Sep 2019

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

Sep 2011

Primary Completion Date

Jun 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Dec 11, 2013

First Submission Date that Met QC Criteria

Oct 24, 2014

First Posted Date

Oct 27, 2014Estimated

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

Sep 17, 2019

Last Update Posted Date

Sep 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations.

Detailed Description

It is well known that left sided heart disease can lead to pulmonary hypertension via a number of proposed mechanisms. The purpose in this study is to identify biomarkers in pulmonary hypertension to further understand the pathophysiology of this disease in patients with heart disease.Patients are recruited in the cardiac catheterization lab, which are undergoing right heart catheterization as per their plan of care established by their primary cardiologist. During the procedure, we will ask the performing cardiologist to obtain a blood sample of 40-50 milliliters from the catheter that they are using during the procedure. These blood samples will be sent for analysis of biomarkers. The patient will then have an echocardiogram done 1 year from their heart catheterization.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high PH and normal PVR		Group I, diastolic heart failure with high PH and normal PVR
high PH and high PVR		Group II, diastolic heart failure with high PH and High PVR
normal PH and normal PVR		Group III, no heart failure, normal PH and normal PVR

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Checking vital statistics on each patient at one year	1 year

Secondary Outcomes

Measure	Description	Time Frame
Morbidity	Checking vital statistics on each patient at one year	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years
Ability to provide informed consent.
Presenting for cardiac catheterization for evaluation of heart disease
Ejection Fraction > 50%

Exclusion Criteria:

Unable to provide informed consent.
Unable or unwilling to comply with the protocol and follow up.
Infiltrative cardiomyopathy
Constrictive pericarditis
Severe valvular disease
Comorbid status with life expectancy <3 years
Right ventricular dysplasia
Congenital heart disease
On immunosuppressive drugs.
Patients who has heart transplant.
Ejection Fraction < 50%
Mean Pulmonary Artery Pressure <25
Wedge pressure <15

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

We will study a cohort of patients that will be recruited from the cath lab during diagnositic heart catheterization

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samer Khouri, MD	University of Toledo Health Science Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Toledo, Health Science Campus		Toledo	Ohio	43606	United States

Condition Browse Module

MeSH Terms

ID	Term
D054144	Heart Failure, Diastolic
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D006333	Heart Failure
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

DNA storage for future exploratory research into genes/genetic variations which may indicate the presence or absence of pulmonary hypertension and congestive heart failure either as an extension of this research protocol or future protocols developed in the study of pulmonary hypertension/chf