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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

Brief Summary

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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

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* 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.

Conditions

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Exercise Tolerance Dyspnea Heart Failure Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 31771997 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31513270 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29957229 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28039229 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25857307 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25697852 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25342738 (View on PubMed)

Other Identifiers

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11-004186

Identifier Type: -

Identifier Source: org_study_id

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