Effects of MICT on Cardiopulmonary Function in Patients After TAVI

Not Applicable

• Conditions: Valve Disease, Aortic; Cardiac Rehabilitation
• Interventions: Behavioral: moderate intensity continuous training

• Registration Number: NCT05015712
• Lead Sponsor: Han Yaling, MD

Brief Summary

Cardiac rehabilitation (CR), particularly regular exercise, can improve the cardiopulmonary function, exercise capacity, and quality of life for patients undergoing transcatheter aortic valve implantation (TAVI). Consequently, the patients after TAVI will be enrolled in our randomized controlled trial to demonstrate if the moderate-intensity continuous training (MICT) can improve the cardiopulmonary function compared with the control group after receiving treatment for 12 weeks. Moreover, we will provide new insights regarding whether cardiac systolic function or cardiac diastolic function is mainly improved after regular exercise for TAVI patients. As a result, the principal hypothesis of our study is that MICT will improve the cardiopulmonary function and can extremely affect the cardiac diastolic function of patients with TAVI after the implementation of exercise for 12 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-07
• Study First Submitted QC: 2021-08-16
• Study Start: 2021-08-20
• Study First Posted: 2021-08-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• TAVI after 1 month
• able to start cardiac rehabilitation(CR) as judged by the study investigators
• age >18 years old
• 6-min walk distance (6MWD) ≥100m
• patients able to provide the informed consent before randomization

Exclusion Criteria

• exercise-limiting comorbidities such as primarily orthopedic, neurological conditions that would exclude the patients from participating in CR
• linguistic deficits
• patient unwilling or unable to provide written informed consent
• patients with acute systemic diseases e.g. hyperthyroidism, electrolyte disturbances, uncontrolled diabetes, hemoglobin< 9 g/dL, uncontrolled asthma, severe obstructive pulmonary disease (forced expiratory volume in 1 second<50%), respiratory failure, and pulmonary embolism
• echocardiographic signs of prosthesis dysfunction including valve orifice area of <1.2 cm2 plus a mean transaortic pressure gradient of ≥20 mmHg, or a velocity of ≥3 m/s, at least moderate paravalvular regurgitation, signs of ischemia, severe arrhythmias, or hemodynamic deterioration during the exercise test
• decompensated heart failure (New York Heart Association (NYHA) class IV)
• patients with irreversible atrial or ventricular arrhythmias or patients with severe atrioventricular block
• bradycardia (heart rate<60bpm) or patients who need implantation of a pacemaker or implantable cardioverter defibrillators (ICD)
• recent history of sudden cardiac death syndrome
• suspected aortic dissection, pericarditis, hypertrophic obstructive cardiomyopathy and subacute bacterial endocarditis
• untreated or uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure >110 mmHg) or hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <60mmHg)
• cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism or other brain disease history
• active or recent major bleeding or bleeding predisposition
• coronary artery bypass grafting (CABG) within 3 months
• renal insufficiency (serum creatinine >2.5 mg/dl)
• planning to, or participation in another intervention study within 3 months
• patients with exercise intolerance or poor exercise endurance
• patients who are currently receiving systematic training
• researchers think it is not suitable to participate in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate intensity continuous training	moderate intensity continuous training	-

Primary Outcome Measures

Name	Time	Method
change in peak oxygen uptake (peak VO2) after 3 months	3 months and 1 year

Secondary Outcome Measures

Name	Time	Method
New York Heart Association class (NYHA)	3 months and 1 year	The NYHA is measured by Classification of NYHA heart function
left atrial volume index(LAVI)	3 months and 1 year	it is measured by echocardiography
left ventricular ejection fraction(LV-EF)	3 months and 1 year	it is measured by echocardiography
valve orifice area	3 months and 1 year	it is measured by echocardiography
N-terminal pro-brain natriuretic peptide (NT-proBNP)	3 months and 1 year
C-reactive protein(CRP)	3 months and 1 year
change in peak oxygen uptake (peak VO2) after 1 year	1 year
6-min walk distance	3 months and 1 year
the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12)	3 months and 1 year
E/e'	3 months and 1 year	it is measured by echocardiography
E/A	3 months and 1 year	it is measured by echocardiography
high density lipoprotein (HDL)	3 months and 1 year
mean pressure gradient(PGmean)	3 months and 1 year	it is measured by echocardiography
maximal pressure gradient (PGmax)	3 months and 1 year	it is measured by echocardiography
triglyceride	3 months and 1 year
low density lipoprotein (LDL)	3 months and 1 year
Major adverse cardiovascular events	3 months and 1 year	Major adverse cardiovascular events is a composite endpoint of death, stroke, revascularization, and myocardial infarction.
maximal velocity(Vmax)	3 months and 1 year	it is measured by echocardiography
hemoglobin	3 months and 1 year
cholesterol	3 months and 1 year

Trial Locations

Locations (1)

Ya-Ling Han; 🇨🇳 Shenyang, Liaoning, China