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Effects of MICT on Cardiopulmonary Function in Patients After TAVI

Primary Purpose

Valve Disease, Aortic, Cardiac Rehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
moderate intensity continuous training
Sponsored by
Han Yaling, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Valve Disease, Aortic focused on measuring transcatheter aortic valve implantation, cardiac rehabilitation, cardiopulmonary function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ya-Ling HanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

moderate intensity continuous training

guideline control

Arm Description

Patients assigned to the guideline control just received 1-time advice on training according to guidelines.

Outcomes

Primary Outcome Measures

change in peak oxygen uptake (peak VO2) after 3 months

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2021
Last Updated
July 12, 2022
Sponsor
Han Yaling, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05015712
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Yaling, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valve Disease, Aortic, Cardiac Rehabilitation
Keywords
transcatheter aortic valve implantation, cardiac rehabilitation, cardiopulmonary function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
moderate intensity continuous training
Arm Type
Experimental
Arm Title
guideline control
Arm Type
No Intervention
Arm Description
Patients assigned to the guideline control just received 1-time advice on training according to guidelines.
Intervention Type
Behavioral
Intervention Name(s)
moderate intensity continuous training
Intervention Description
Moderate intensity continuous training was scheduled 3 times per week for 3 months. Every sessions included warm-up (<50% target intensity for 2 min then gradually increasing load 1-10 W/min up to 100% target intensity for 5-10 min), exercise phase (100% target intensity (heart rate at anaerobic threshold±5) starting with 20 min and gradually lengthening up to 45 min in the 1 month as well as 45 min in another 2 months), cool down with gradual reduction of load within 3 min. The target intensity will be determined by the heart rate at anaerobic threshold measured by cardiopulmonary exercise test (CPET). The intensity will be adjusted after implementation of CPET and will keep at a minimum intensity, gradually increasing to the maximum intensity every month. Moreover, patients will be instructed to complete 2 supervised sessions and 1 home-based session during the 1 month and then to continue 3 home-based session for a further 2 months.
Primary Outcome Measure Information:
Title
change in peak oxygen uptake (peak VO2) after 3 months
Time Frame
3 months and 1 year
Secondary Outcome Measure Information:
Title
6-min walk distance
Time Frame
3 months and 1 year
Title
the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12)
Time Frame
3 months and 1 year
Title
New York Heart Association class (NYHA)
Description
The NYHA is measured by Classification of NYHA heart function
Time Frame
3 months and 1 year
Title
E/e'
Description
it is measured by echocardiography
Time Frame
3 months and 1 year
Title
E/A
Description
it is measured by echocardiography
Time Frame
3 months and 1 year
Title
left atrial volume index(LAVI)
Description
it is measured by echocardiography
Time Frame
3 months and 1 year
Title
left ventricular ejection fraction(LV-EF)
Description
it is measured by echocardiography
Time Frame
3 months and 1 year
Title
mean pressure gradient(PGmean)
Description
it is measured by echocardiography
Time Frame
3 months and 1 year
Title
maximal pressure gradient (PGmax)
Description
it is measured by echocardiography
Time Frame
3 months and 1 year
Title
maximal velocity(Vmax)
Description
it is measured by echocardiography
Time Frame
3 months and 1 year
Title
valve orifice area
Description
it is measured by echocardiography
Time Frame
3 months and 1 year
Title
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time Frame
3 months and 1 year
Title
C-reactive protein(CRP)
Time Frame
3 months and 1 year
Title
hemoglobin
Time Frame
3 months and 1 year
Title
cholesterol
Time Frame
3 months and 1 year
Title
triglyceride
Time Frame
3 months and 1 year
Title
high density lipoprotein (HDL)
Time Frame
3 months and 1 year
Title
low density lipoprotein (LDL)
Time Frame
3 months and 1 year
Title
Major adverse cardiovascular events
Description
Major adverse cardiovascular events is a composite endpoint of death, stroke, revascularization, and myocardial infarction.
Time Frame
3 months and 1 year
Title
change in peak oxygen uptake (peak VO2) after 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Ling Han, PhD
Phone
+862428897309
Email
hanyaling@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-Ling Han, PhD
Organizational Affiliation
Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ya-Ling Han
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaling Han, PhD
Phone
02428897309
Email
hanyaling@263.net

12. IPD Sharing Statement

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Effects of MICT on Cardiopulmonary Function in Patients After TAVI

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