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

Heart Failure Clinical Trial

— EXEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418248
• Other study ID #: 11-004186
• Status: Completed
• Phase: N/A
• First received: August 15, 2011
• Last updated: January 8, 2014
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspnea
• Exercise Tolerance
• Heart Failure
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Vascular Diseases

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Utility ExE and CPX		Same day as clinically indicated Right Heart Catheterization (RHCath)	No
Secondary	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	No