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

Completed

• Conditions: Dyspnea; Heart Failure; Pulmonary Hypertension; Exercise Tolerance

• Registration Number: NCT01418248
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-17
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Utility ExE and CPX	Same day as clinically indicated Right Heart Catheterization (RHCath)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States