Study of Exercise and Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease (EXEC)

January 8, 2014 updated by: Mayo Clinic

Evaluation of Exercise Intolerance and Right Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease

Heart Failure with Preserved Ejection Fraction (HFpEF) and Pulmonary Hypertension (PH) can be diagnosed noninvasively by Exercise Echocardiography (ExE) and Cardiopulmonary Exercise Testing (CPX) as compared with gold standard invasive hemodynamic assessment.

Study Overview

Status

Completed

Conditions

Detailed Description

  • The broad objective of this proposal is to characterize the dynamic changes in cardiopulmonary mechanics during stress in patients with exertional dyspnea, establishing a comprehensive multimodality diagnostic approach to the evaluation of exercise intolerance.
  • The specific objective is to prospectively compare established and novel parameters derived from echocardiography and CPX with simultaneous, gold standard invasive measures of cardiovascular hemodynamics at rest and with exercise stress to define the role of noninvasive testing in the diagnostic workup.
  • The primary hypothesis is that combined ExE and CPX can noninvasively identify HFpEF.

Study Type

Observational

Enrollment (Actual)

108

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

Cardiac Catheterization Laboratory

Description

Inclusion Criteria:

  • exertional intolerance/dyspnea of unknown etiology
  • referral to cardiac catheterization laboratory
  • undergoing invasive hemodynamic evaluation for clinical purposes

Exclusion Criteria:

  • hypertrophic cardiomyopathy
  • constrictive pericarditis
  • infiltrative myopathy (e.g. amyloid)
  • congenital heart disease
  • resting LVEF <50%
  • > moderate mitral annular calcification
  • moderate or greater left-sided valvular stenosis or regurgitation
  • prior valve surgery
  • basal septal wall motion abnormalities
  • >70% epicardial coronary artery stenosis
  • right ventricular infarction
  • pregnancy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic Utility ExE and CPX
Time Frame: Same day as clinically indicated Right Heart Catheterization (RHCath)
Same day as clinically indicated Right Heart Catheterization (RHCath)

Secondary Outcome Measures

Outcome Measure
Time Frame
Multiple integrated measures of cardiovascular function derived from RHCath, ExE and CPX along with rest/exercise natriuretic peptide levels
Time Frame: Same day as clinically indicated RHCath
Same day as clinically indicated RHCath

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2011

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (ESTIMATE)

August 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-004186

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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