The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure

NCT ID: NCT02275793

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diastolic Heart Failure Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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high PH and normal PVR

Group I, diastolic heart failure with high PH and normal PVR

No interventions assigned to this group

high PH and high PVR

Group II, diastolic heart failure with high PH and High PVR

No interventions assigned to this group

normal PH and normal PVR

Group III, no heart failure, normal PH and normal PVR

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toledo Health Science Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samer Khouri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toledo Health Science Campus

Locations

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University of Toledo, Health Science Campus

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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PVR

Identifier Type: -

Identifier Source: org_study_id

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