Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04822649
Other study ID # 2020AN0030
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 15, 2021
Est. completion date December 2024

Study information

Verified date September 2023
Source Korea University Anam Hospital
Contact So Ree Kim, MD
Phone 821094534810
Email soree8826kim@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Heart Failure
  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Intervention

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 (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.

Locations

Country Name City State
Korea, Republic of Korea University Anam Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
up to day 14
Primary 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.
up to day 14
See also
  Status Clinical Trial Phase
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2
Recruiting NCT05441839 - UK Heart Failure With Preserved Ejection Fraction
Completed NCT01989299 - Ventricular Tachyarrhythmia Detection by Implantable Loop Recording in Patients With Heart Failure and Preserved Ejection Fraction
Terminated NCT03909295 - An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan. Phase 3
Completed NCT04327024 - Study of Verinurad in Heart Failure With Preserved Ejection Fraction Phase 2
Active, not recruiting NCT05136820 - Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study N/A
Completed NCT03988634 - Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF) Phase 3
Recruiting NCT03876223 - Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF
Completed NCT04232345 - A Study to Assess the Effect AZD4831 in Japanese and Chinese Healthy Volunteers Phase 1
Recruiting NCT05792059 - DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction
Completed NCT03843060 - A Phase 1 Study to Assess the Pharmacokinetics of AZD9977 Administered Alone and in Combination With Itraconazole in Healthy Volunteers Phase 1
Completed NCT01714752 - Evaluation of Left Ventricular Filling Pressures During Exercise N/A
Completed NCT06036186 - Study for the Treatment of Heart Failure With Preserved Ejection Fraction Associated With High Blood Pressure Using Right Atrial Pacing Controlled by the PressurePaceTM System N/A
Recruiting NCT05383287 - Characteristics, Phenotypes, and TRAITS of Heart Failure With Preserved Ejection Fraction (TRAITS-HFpEF)
Completed NCT03877224 - DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction Phase 3
Active, not recruiting NCT04847557 - A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial Phase 3