The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure

Pulmonary Hypertension Clinical Trial

— PVR  

Official title:

The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275793
• Other study ID #: PVR
• Status: Completed
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: September 2019
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Checking vital statistics on each patient at one year	1 year
Secondary	Morbidity	Checking vital statistics on each patient at one year	1 year