CPX in Paradoxical Low Flow Aortic Stenosis

The Role of Cardiopulmonary Stress Testing in Diagnostic Evaluation of Paradoxical Low Gradient Aortic Valve Stenosis

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.

Study Overview

• Status: Withdrawn
• Conditions: Aortic Valve Stenosis

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with paradoxical low flow low gradient aortic stenosis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	Evaluate changes in rest vs. Peak V02 at maximal exercise capacity.	August 30 2017-April 30 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up	Follow patients long term for major adverse cardiac events including myocardial infarction, stroke, hospitalization, or death and if CPX parameters provide further prognostic information in this patient population	August 30 2017- August 30 2019

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Karthikeyan Ananthasubramaniam, MD, Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: PLFLGAS1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No