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Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

Sponsor
Korea University Anam Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04822649
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
22.5
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The correlation of coronary microvascular function and body composition with cardiopulmonary exercise capacity will be assessed in patients with heart failure with preserved ejection fraction.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Adenosine stress echocardiography with the evaluation of coronary artery blood flow
 N/A

Detailed Description

We will select the patients with chest pain or ischemic symptoms with non-obstructive coronary artery disease (<50% stenosis) in coronary angiography and preserved ejection fraction (≥50%) in echocardiography. All patients will undergo body composition analysis and adenosine stress echocardiography with the evaluation of coronary artery blood flow by Doppler echocardiography and maximal oxygen consumption (VO2 max) by cardiopulmonary exercise test. Left ventricular end-diastolic pressure will be assessed during coronary angiography. Coronary flow reserve (CFR) is defined as the ratio of peak to baseline mean diastolic velocity of coronary blood flow. The correlation of CFR and body composition with cardiopulmonary exercise capacity will be assessed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients with chest pain or ischemic symptoms with non-obstructive coronary artery disease (<50% stenosis) in coronary angiography and preserved ejection fraction (>50%) in echocardiography.Patients with chest pain or ischemic symptoms with non-obstructive coronary artery disease (<50% stenosis) in coronary angiography and preserved ejection fraction (>50%) in echocardiography.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Differences in Cardiopulmonary Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition in Patients With Suspected Heart Failure With Preserved Ejection Fraction
Actual Study Start Date :
Apr 15, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Heart failure with preserved ejection fraction

Adenosine stress echocardiography, body composition, and cardiopulmonary exercise test will be done in all of the enrolled patients. Left ventricular end-diastolic pressure will be assessed during coronary angiography.

Diagnostic Test: Adenosine stress echocardiography with the evaluation of coronary artery blood flow
The color Doppler flow of distal left anterior descending artery will be examined from the modified apical four-chamber view in the anterior interventricular groove. In regard to body composition analysis, Using InBody S10, impedance is measured in 6 frequency bands (1kHz, 5kHz, 50kHz, 250kHz, 500kHz, 1000kHz) for each of 5 parts (right plate, left arm, torso, right leg, left leg). Reactance is measured in 3 frequency bands (5kHz, 50kHz, 250kHz for each of 5 parts (right arm, left arm, torso, right leg, left leg). By treadmill exercise test with modified Bruce protocol or bicycle ergometer for patients with orthopedic problems, maximal oxygen consumption (VO2 max) will be measured using the exhalation gas analysis.
Other Names:
  • Body composition analysis
  • Cardiopulmonary exercise test

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of coronary blood flow with cardiopulmonary exercise capacity [up to day 14]

      Coronary blood flow is assessed by coronary flow reserve (CFR), which is defined as peak to baseline mean diastolic velocity of coronary flow. In regard to cardiopulmonary exercise capacity, maximal oxygen consumption (VO2max) will be assessed.

    2. Correlation of body composition with cardiopulmonary exercise capacity [up to day 14]

      In body composition analysis, skeletal muscle mass and body fat mass will be assessed. In regard to cardiopulmonary exercise capacity, maximal oxygen consumption (VO2max) will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 20 to 80

    • Typical/atypical chest pain or ischemic symptoms including dyspnea

    • No significant coronary artery stenosis (>50% stenosis) in coronary angiography or computed tomography

    • Left ventricular ejection fraction ≥50%

    Exclusion Criteria:

    • More than moderate valvular heart disease

    • Congenital heart disease

    • Chronic renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or end-stage renal failure undergoing hemodialysis or peritoneal dialysis

    • Asthma, chronic obstructive pulmonary disease and primary pulmonary hypertension

    • Receiving anticancer drugs

    • Vasculitis associated with autoimmune diseases

    • Patients with difficulty in performing exercise load evaluation (treadmill, bicycle ergometer)

    • Atrial fibrillation

    • Atrioventricular block with more than second degrees, symptomatic bradycardia, cryo-node failure syndrome, Wolff-Parkinson-White (WPW) patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Anam Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Korea University Anam Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seong-Mi Park, M.D. Ph.D., Professor, Korea University Anam Hospital
    ClinicalTrials.gov Identifier:
    NCT04822649
    Other Study ID Numbers:
    • 2020AN0030
    First Posted:
    Mar 30, 2021
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seong-Mi Park, M.D. Ph.D., Professor, Korea University Anam Hospital
    Body composition, CPET, CFR, CMD, Frailty, HFpEF
    Additional relevant MeSH terms:
    Heart Failure
    Adenosine

    Study Results

    No Results Posted as of Sep 1, 2021