Clinical trial NCT01418248: Study of Exercise and Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease
Official title: Evaluation of Exercise Intolerance and Right Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Tolerance
Dyspnea
Heart Failure
Pulmonary Hypertension
Keywords: cardiac catheterization
echocardiography
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac Catheterization Laboratory

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.

Eligibility 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

Primary outcomes:
measure: Diagnostic Utility ExE and CPX
timeFrame: Same day as clinically indicated Right Heart Catheterization (RHCath)
Secondary outcomes:
measure: Multiple integrated measures of cardiovascular function derived from RHCath, ExE and CPX along with rest/exercise natriuretic peptide levels
timeFrame: Same day as clinically indicated RHCath
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barry Borlaug, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.