Study of Exercise and Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease (EXEC)
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 Design:||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|
- Diagnostic Utility ExE and CPX [ Time Frame: Same day as clinically indicated Right Heart Catheterization (RHCath) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||August 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418248
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Barry Borlaug, MD||Mayo Clinic|