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

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ClinicalTrials.gov Identifier: NCT02275793
Recruitment Status : Recruiting
First Posted : October 27, 2014
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Diastolic Heart Failure Pulmonary Hypertension

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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Study Start Date : September 2011
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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



Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]
    Checking vital statistics on each patient at one year


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 1 year ]
    Checking vital statistics on each patient at one year


Biospecimen Retention:   Samples With DNA
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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275793


Contacts
Contact: Denise Zeller, RN 419-383-3853 Stephanie.marts@utoledo.edu

Locations
United States, Ohio
University of Toledo, Health Science Campus Recruiting
Toledo, Ohio, United States, 43606
Contact: Samer Khouri, MD    419-383-3697    samer.khouri@utoledo.edu   
Contact: Denise Zeller, RN    419-383-3853    Denise.Zeller@utoledo.edu   
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
Principal Investigator: Samer Khouri, MD University of Toledo Health Science Campus

Responsible Party: University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT02275793     History of Changes
Other Study ID Numbers: PVR
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Heart Failure
Hypertension, Pulmonary
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases