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Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

Primary Purpose

Heart Failure With Preserved Ejection Fraction (HFpEF)

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Adenosine stress echocardiography with the evaluation of coronary artery blood flow

About this trial

This is an interventional diagnostic trial for Heart Failure With Preserved Ejection Fraction (HFpEF) focused on measuring body composition, CPET, CFR, coronary microvascular dysfunction (CMD), frailty, HFpEF

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Heart failure with preserved ejection fraction

Arm Description

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.

Outcomes

Primary Outcome Measures

Correlation of coronary blood flow with cardiopulmonary exercise capacity

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.

Correlation of body composition with cardiopulmonary exercise capacity

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04822649

First Posted

March 18, 2021

Last Updated

September 25, 2023

Sponsor

Korea University Anam Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04822649

Brief Title

Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 15, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Korea University Anam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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 (CPET). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure With Preserved Ejection Fraction (HFpEF)

Keywords

body composition, CPET, CFR, coronary microvascular dysfunction (CMD), frailty, HFpEF

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Heart failure with preserved ejection fraction

Arm Type

Other

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Adenosine stress echocardiography with the evaluation of coronary artery blood flow

Other Intervention Name(s)

Body composition analysis, Cardiopulmonary exercise test

Intervention Description

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 (1 kilohertz (kHz), 5 kHz, 50 kHz, 250 kHz, 500 kHz, 1000 kHz) for each of 5 parts (right plate, left arm, torso, right leg, left leg). Reactance is measured in 3 frequency bands (5 kHz, 50 kHz, 250 kHz 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.

Primary Outcome Measure Information:

Title

Correlation of coronary blood flow with cardiopulmonary exercise capacity

Description

Time Frame

up to day 14

Title

Correlation of body composition with cardiopulmonary exercise capacity

Description

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.

Time Frame

up to day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

So Ree Kim, MD

Phone

821094534810

soree8826kim@gmail.com

Facility Information:

Facility Name

Korea University Anam Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

So Ree Kim, MD

soree8826kim@gmail.com

First Name & Middle Initial & Last Name & Degree

Seong-Mi Park

First Name & Middle Initial & Last Name & Degree

Mi-Na Kim

First Name & Middle Initial & Last Name & Degree

So Ree Kim

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36262558

Citation

Kim SR, Cho DH, Kim MN, Park SM. Rationale and Study Design of Differences in Cardiopulmonary Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition in Patients with Suspected Heart Failure with Preserved Ejection Fraction. Int J Heart Fail. 2021 Sep 14;3(4):237-243. doi: 10.36628/ijhf.2021.0029. eCollection 2021 Oct.

Results Reference

derived

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Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

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