CPX in Paradoxical Low Flow Aortic Stenosis

NCT ID: NCT05481814

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2022-07-01

Brief Summary

Severe aortic stenosis is a condition with poor life expectancy once it becomes symptomatic. There are no prospective studies illustrating the utility of cardiopulmonary stress (CPX) testing in diagnosing and prognosticating patients with paradoxically low gradient and low flow severe aortic stenosis. We aim to prospectively investigate the utility of CPX in this patient population with the hypothesis that utilizing CPX parameters would better identify higher risk patients warranting further evaluation and possibly intervention sooner.

Detailed Description

This will be a prospective crossectional, longitudinal study recruiting patients by invitation with paradoxical low flow low gradient severe aortic stenosis. Patients with PLFLG AS will have been identified in other studies and these patients will be approached for enrollment in the study. Patients deemed appropriate for enrollment will undergo recumbent bicycle stress testing with concomitant measure of gas exchange. The bicycle will be at 30 degrees with initiation of minimal resistance for 3 minutes, followed by an increase in work-rate of 25 watts every two minutes until the patient reaches a sign/symptom-limited maximum exertion or test limiting symptoms develop. Charts will be reviewed for baseline medical conditions and demographics. CPX protocol will be standard HFH protocol supervised by exercise physiologist. The first phase of the study will be investigating if these asymptomatic patients will be reclassified to symptomatic as defined by reduced V02 Max. The second phase will be following these patients for long term adverse events and if V02 max correlates with a higher risk.

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Aortic valve area <1 cm2
• Mean aortic pressure gradient <40 mmHg,
• Left ventricular ejection fraction >50% by 2D transthoracic echocardiography

Exclusion Criteria

• Ischemic heart disease
• Severe mitral valve disease (regurgitation or stenosis)
• Moderate or severe aortic regurgitation
• Pulmonary hypertension (PA pressure >50 mmHg)
• COPD
• Uncontrolled hypertension (Systolic BP or Diastolic BP greater than 150/90)
• Inability or unwillingness to exercise.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Karthikeyan Ananthasubramaniam

Senior Staff Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karthikeyan Ananthasubramaniam, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Countries

United States

Other Identifiers

PLFLGAS1

Identifier Type: -

Identifier Source: org_study_id