The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure (PVR)

September 17, 2019 updated by: University of Toledo Health Science Campus
Peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Toledo, Ohio, United States, 43606
        • University of Toledo, Health Science Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toledo Health Science Campus

Investigators

  • Principal Investigator: Samer Khouri, MD, University of Toledo Health Science Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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