Clinical trial NCT05015712: Effects of MICT on Cardiopulmonary Function in Patients After TAVI
Official title: Effects of Moderate Intensity Continuous Training (MICT) on Cardiopulmonary Function in Patients After Transcatheter Aortic Valve Implantation (TAVI): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Valve Disease, Aortic
Cardiac Rehabilitation
Keywords: transcatheter aortic valve implantation
cardiac rehabilitation
cardiopulmonary function
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in peak oxygen uptake (peak VO2) after 3 months
timeFrame: 3 months and 1 year
Secondary outcomes:
measure: 6-min walk distance
timeFrame: 3 months and 1 year
measure: the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12)
timeFrame: 3 months and 1 year
measure: New York Heart Association class (NYHA)
timeFrame: 3 months and 1 year
measure: E/e'
timeFrame: 3 months and 1 year
measure: E/A
timeFrame: 3 months and 1 year
measure: left atrial volume index(LAVI)
timeFrame: 3 months and 1 year
measure: left ventricular ejection fraction(LV-EF)
timeFrame: 3 months and 1 year
measure: mean pressure gradient(PGmean)
timeFrame: 3 months and 1 year
measure: maximal pressure gradient (PGmax)
timeFrame: 3 months and 1 year
measure: maximal velocity(Vmax)
timeFrame: 3 months and 1 year
measure: valve orifice area
timeFrame: 3 months and 1 year
measure: N-terminal pro-brain natriuretic peptide (NT-proBNP)
timeFrame: 3 months and 1 year
measure: C-reactive protein(CRP)
timeFrame: 3 months and 1 year
measure: hemoglobin
timeFrame: 3 months and 1 year
measure: cholesterol
timeFrame: 3 months and 1 year
measure: triglyceride
timeFrame: 3 months and 1 year
measure: high density lipoprotein (HDL)
timeFrame: 3 months and 1 year
measure: low density lipoprotein (LDL)
timeFrame: 3 months and 1 year
measure: Major adverse cardiovascular events
timeFrame: 3 months and 1 year
measure: change in peak oxygen uptake (peak VO2) after 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Ya-Ling Han
state: Liaoning
Study officials:
affiliation: Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
name: Ya-Ling Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: