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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01418248
First received: August 15, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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
Exercise Tolerance
Dyspnea
Heart Failure
Pulmonary Hypertension

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Diagnostic Utility ExE and CPX [ Time Frame: Same day as clinically indicated Right Heart Catheterization (RHCath) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

Serum, plasma


Enrollment: 108
Study Start Date: August 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Barry Borlaug, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01418248     History of Changes
Other Study ID Numbers: 11-004186
Study First Received: August 15, 2011
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
cardiac catheterization
echocardiography

Additional relevant MeSH terms:
Heart Failure
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014