NCT05481814

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 28, 2022

Last Update Submit

July 29, 2022

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Functional status

    Evaluate changes in rest vs. Peak V02 at maximal exercise capacity.

    August 30 2017-April 30 2017

Secondary Outcomes (1)

  • Follow-up

    August 30 2017- August 30 2019

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with paradoxical low flow low gradient aortic stenosis

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Karthikeyan Ananthasubramaniam, MD

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Cardiologist

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 1, 2022

Study Start

September 30, 2017

Primary Completion

April 1, 2018

Study Completion

July 1, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations

US(1)