Cardiopulmonary and Right Ventricular Function in Health and Disease

NCT04147299 | Unknown

• 1 other identifier: 19-1141
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction \[HFrEF\], heart failure with preserved ejection fraction \[HFpEF\]), as well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event.

Conditions

Heart Failure; Athletes Heart

Keywords

Right Ventricular Function

Outcome Measures

Primary Outcomes (3)

• Cardiac output

  measured in L/min from the catheter during exercise.

  1-2 years

• Contractility

  measured by dpdt, mmHg/sec

  1-2 years

• Diastolic function

  measured by dpdt, mmHg/sec

  1-2 years

Study Arms (3)

HFrEF

Heart Failure with Reduced Ejection Fraction

HFpEF

Heart Failure with Preserved Ejection Fraction

Elite Athletes

Endurance athletes

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HFrEF - 20 participants - Individuals with clinical heart failure, with left ventricular ejection fraction \< 50% on a recent echocardiogram within past 6 months. HFpEF - 20 participants - Individuals with clinical heart failure symptoms, but with left ventricular ejection fraction 50% or greater on a recent echocardiogram within past 6 months. Patients must have imaging evidence of diastolic dysfunction, such as an E/e' ratio \> 14, evidence of grade 2 or greater diastolic dysfunction or a restrictive filling pattern on imaging. Elite/Endurance Athletes - 20 participants - Individuals 18+ years of age who participate in endurance exercise primarily through bicycling (e.g. cyclists or triathletes)

You may qualify if:

• Individuals with clinical heart failure, with left ventricular ejection fraction \< 50% on a recent echocardiogram within past 6 months.
• Patients must be ambulatory, clinically stable and able to perform exercise on a stationary bicycle.
• Preserved right ventricular function. Right ventricular dysfunction will be defined by: imaging evidence of RV dysfunction on echocardiogram, with tricuspid annular plane systolic excursion (TAPSE) \< 17mm6; hemodynamic evidence of RV dysfunction, defined by elevated right-sided filling pressures (RAP) on a clinically obtained right heart catheterization and a ratio of RAP to pulmonary capillary wedge ratio (PCWP) greater than two-thirds; clinical evidence of RV dysfunction, defined by elevated jugular venous pulsations and 3-4+ peripheral edema.

You may not qualify if:

• Non-cardiac factors that preclude the ability to exercise, such as (but not limited to) osteoarthritis or any other musculoskeletal disease; peripheral vascular disease.
• Uncontrolled atrial or ventricular arrhythmias
• Significant valvular disease (\>mild stenosis, \>moderate regurgitation), cor pulmonale, significant pulmonary disease, congenital heart disease, left-to-right shunt, unstable coronary artery disease, hypertrophic cardiomyopathy, high-output heart failure, or constrictive pericarditis.
• The primary-investigator will reserve authority to use best clinical judgment to exclude patients from consideration for participation as case-based situations arise.
• Any acute/recent illness that would render the individual unable to participate in this study, as determined by the primary investigator.
• Heart failure with preserved ejection fraction (HFpEF):
• individuals with clinical heart failure symptoms, but with left ventricular ejection fraction 50% or greater on a recent echocardiogram within past 6 months. Patients must have imaging evidence of diastolic dysfunction, such as an E/e' ratio \> 14, evidence of grade 2 or greater diastolic dysfunction or a restrictive filling pattern on imaging.
• Patients must have an elevated brain-natriuretic peptide (BNP) of 80+ pg/ml (ever) or an NT-pro BNP of 125+ pg/ml (ever). Patients must be ambulatory and able to perform exercise on a stationary bicycle.
• If patients have a normal BNP (or NT-pro BNP), they must have a history of elevated left-sided filling pressures (e.g. PCWP, or left ventricular end-diastolic pressure) \> 15mmHg on a clinically-indicated right heart catheterization at rest, or 25+mmHg during exercise.
• Preserved right ventricular function. Right ventricular dysfunction will be defined by: imaging evidence of RV dysfunction on echocardiogram, with tricuspid annular plane systolic excursion (TAPSE) \< 17mm6; hemodynamic evidence of RV dysfunction, defined by elevated right-sided filling pressures (RAP) on a clinically obtained right heart catheterization and a ratio of RAP to pulmonary capillary wedge ratio (PCWP) greater than two-thirds; clinical evidence of RV dysfunction, defined by elevated jugular venous pulsations and 3-4+ peripheral edema.
• Non-cardiac factors that preclude the ability to exercise, such as (but not limited to) osteoarthritis or any other musculoskeletal disease; peripheral vascular disease.
• Uncontrolled atrial or ventricular arrhythmias
• Significant valvular disease (\>mild stenosis, \>moderate regurgitation), cor pulmonale, significant pulmonary disease, congenital heart disease, left-to-right shunt, unstable coronary artery disease, hypertrophic cardiomyopathy, high-output heart failure, or constrictive pericarditis.
• The primary-investigator will reserve authority to use best clinical judgment to exclude patients from consideration for participation as case-based situations arise.
• Any acute/recent illness that would render the individual unable to participate in this study, as determined by the primary investigator.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• William Cornwell, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: November 1, 2019
• Study Start: February 15, 2020
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)