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

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Mayo Clinic

Status

Completed

Conditions

Dyspnea
Exercise Tolerance
Heart Failure
Pulmonary Hypertension

Study type

Observational

Funder types

Other

Identifiers

NCT01418248
11-004186

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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