The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure

Completed

• Conditions: Pulmonary Hypertension; Diastolic Heart Failure

• Registration Number: NCT02275793
• Lead Sponsor: University of Toledo Health Science Campus

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2014-10-24
• Study First Posted: 2014-10-27
• Primary Completion: 2015-06
• Study Completion: 2015-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	1 year	Checking vital statistics on each patient at one year

Secondary Outcome Measures

Name	Time	Method
Morbidity	1 year	Checking vital statistics on each patient at one year

Trial Locations

Locations (1)

University of Toledo, Health Science Campus; 🇺🇸 Toledo, Ohio, United States