Study of Exercise and Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease
NCT ID: NCT01418248
Last Updated: 2014-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
108 participants
OBSERVATIONAL
2011-08-31
2013-08-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* referral to cardiac catheterization laboratory
* undergoing invasive hemodynamic evaluation for clinical purposes
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic
Principal Investigators
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Barry Borlaug, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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.
Obokata 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.
Obokata 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.
Obokata 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.
Andersen 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.
Kobashigawa 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.
Andersen 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.
Other Identifiers
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11-004186
Identifier Type: -
Identifier Source: org_study_id
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