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Clinical Trials/NCT01418248
NCT01418248
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country108 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exercise Tolerance
Sponsor
Mayo Clinic
Enrollment
108
Locations
1
Primary Endpoint
Diagnostic Utility ExE and CPX
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
August 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnostic Utility ExE and CPX

Time Frame: Same day as clinically indicated Right Heart Catheterization (RHCath)

Secondary Outcomes

  • Multiple integrated measures of cardiovascular function derived from RHCath, ExE and CPX along with rest/exercise natriuretic peptide levels(Same day as clinically indicated RHCath)

Study Sites (1)

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