Study of Exercise and Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease
EXEC
Evaluation of Exercise Intolerance and Right Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease
1 other identifier
observational
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 15, 2011
CompletedFirst Posted
Study publicly available on registry
August 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJanuary 9, 2014
January 1, 2014
2 years
August 15, 2011
January 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic Utility ExE and CPX
Same day as clinically indicated Right Heart Catheterization (RHCath)
Secondary Outcomes (1)
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
Eligibility Criteria
Cardiac Catheterization Laboratory
You may qualify if:
- exertional intolerance/dyspnea of unknown etiology
- referral to cardiac catheterization laboratory
- undergoing invasive hemodynamic evaluation for clinical purposes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (7)
Obokata M, Kane GC, Sorimachi H, Reddy YNV, Olson TP, Egbe AC, Melenovsky V, Borlaug BA. Noninvasive evaluation of pulmonary artery pressure during exercise: the importance of right atrial hypertension. Eur Respir J. 2020 Feb 12;55(2):1901617. doi: 10.1183/13993003.01617-2019. Print 2020 Feb.
PMID: 31771997DERIVEDObokata M, Kane GC, Reddy YNV, Melenovsky V, Olson TP, Jarolim P, Borlaug BA. The neurohormonal basis of pulmonary hypertension in heart failure with preserved ejection fraction. Eur Heart J. 2019 Dec 1;40(45):3707-3717. doi: 10.1093/eurheartj/ehz626.
PMID: 31513270DERIVEDObokata M, Reddy YNV, Melenovsky V, Kane GC, Olson TP, Jarolim P, Borlaug BA. Myocardial Injury and Cardiac Reserve in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2018 Jul 3;72(1):29-40. doi: 10.1016/j.jacc.2018.04.039.
PMID: 29957229DERIVEDObokata M, Kane GC, Reddy YN, Olson TP, Melenovsky V, Borlaug BA. Role of Diastolic Stress Testing in the Evaluation for Heart Failure With Preserved Ejection Fraction: A Simultaneous Invasive-Echocardiographic Study. Circulation. 2017 Feb 28;135(9):825-838. doi: 10.1161/CIRCULATIONAHA.116.024822. Epub 2016 Dec 30.
PMID: 28039229DERIVEDAndersen MJ, Hwang SJ, Kane GC, Melenovsky V, Olson TP, Fetterly K, Borlaug BA. Enhanced pulmonary vasodilator reserve and abnormal right ventricular: pulmonary artery coupling in heart failure with preserved ejection fraction. Circ Heart Fail. 2015 May;8(3):542-50. doi: 10.1161/CIRCHEARTFAILURE.114.002114. Epub 2015 Apr 9.
PMID: 25857307DERIVEDKobashigawa J, Patel J, Azarbal B, Kittleson M, Chang D, Czer L, Daun T, Luu M, Trento A, Cheng R, Esmailian F. Randomized pilot trial of gene expression profiling versus heart biopsy in the first year after heart transplant: early invasive monitoring attenuation through gene expression trial. Circ Heart Fail. 2015 May;8(3):557-64. doi: 10.1161/CIRCHEARTFAILURE.114.001658. Epub 2015 Feb 19.
PMID: 25697852DERIVEDAndersen MJ, Olson TP, Melenovsky V, Kane GC, Borlaug BA. Differential hemodynamic effects of exercise and volume expansion in people with and without heart failure. Circ Heart Fail. 2015 Jan;8(1):41-8. doi: 10.1161/CIRCHEARTFAILURE.114.001731. Epub 2014 Oct 23.
PMID: 25342738DERIVED
Biospecimen
Serum, plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barry Borlaug, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 15, 2011
First Posted
August 17, 2011
Study Start
August 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
January 9, 2014
Record last verified: 2014-01