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

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ClinicalTrials.gov Identifier: NCT01418248
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : January 9, 2014
Sponsor:
Information provided by:
Mayo Clinic

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.

Condition or disease
Exercise Tolerance Dyspnea Heart Failure Pulmonary Hypertension

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
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Exercise Intolerance and Right Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease
Study Start Date : August 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Diagnostic Utility ExE and CPX [ Time Frame: Same day as clinically indicated Right Heart Catheterization (RHCath) ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Serum, plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac Catheterization Laboratory
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
  • right ventricular infarction
  • pregnancy

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): NCT01418248


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Barry Borlaug, MD Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barry Borlaug, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01418248     History of Changes
Other Study ID Numbers: 11-004186
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by Mayo Clinic:
cardiac catheterization
echocardiography

Additional relevant MeSH terms:
Heart Failure
Hypertension, Pulmonary
Vascular Diseases
Dyspnea
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms