NCT04038723

Brief Summary

The study aimed to highlight the effect of high-intensity interval training (HIIT) on cardiac fibrosis in cardiac patients. From 2009-2018, cardiac patients with measurements of VO2peak, b-type natriuretic peptide, quality of life questionnaire, cardiovascular magnetic resonance imaging with late gadolinium enhancement (CMR-LGE), and preserved serum before and after 36 times of HIIT were enrolled. The human cardiac fibroblast (CF) isolated from human adult ventricle is treated with sera before and after HIIT. Measurements of cell migration as well as cell proliferation and global cell protein profiles before and after HIIT will be performed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
Last Updated

July 31, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

June 18, 2019

Last Update Submit

July 28, 2019

Conditions

Keywords

FibrosisVentricle RemodelingExercise TrainingProteomics

Outcome Measures

Primary Outcomes (6)

  • Cardiac output (CO)

    Cardiac output in milliliter per minute measured by cardiac magnetic resonance imaging with late gadolinium enhancement before and after exercise training

    3-4 months (for 36 times of exercise training)

  • Cardiac mass

    Cardiac mass in gram measured by cardiac magnetic resonance imaging with late gadolinium enhancement before and after exercise training

    3-4 months (for 36 times of exercise training)

  • Left ventricular end-systolic volume (LVESV)

    LVESV in milliliter measured by cardiac magnetic resonance imaging with late gadolinium enhancement before and after exercise training

    3-4 months (for 36 times of exercise training)

  • Left ventricular end-diastolic volume (LVEDV)

    LVEDV in milliliter measured by cardiac magnetic resonance imaging with late gadolinium enhancement before and after exercise training

    3-4 months (for 36 times of exercise training)

  • Extracellular volume fraction (ECV)

    ECV in percent (%) measured by cardiac magnetic resonance imaging with late gadolinium enhancement before and after exercise training

    3-4 months (for 36 times of exercise training)

  • Proteomics

    Protein level changes in fold change in cardiac fibroblast before and after exercise training

    3-4 months (for 36 times of exercise training)

Secondary Outcomes (12)

  • Peak exercise capacity (VO2peak)

    3-4 months (for 36 times of exercise training)

  • Peak cardiac output (CO)

    3-4 months (for 36 times of exercise training)

  • Oxygen uptake efficiency slope (OUES)

    3-4 months (for 36 times of exercise training)

  • Ventilation/VCO2 ratio (Ve-VCO2)

    3-4 months (for 36 times of exercise training)

  • Migration speed

    3-4 months (for 36 times of exercise training)

  • +7 more secondary outcomes

Study Arms (1)

Pre- and Post-HIIT

EXPERIMENTAL

Participants will be evaluated before and after exercise training.

Behavioral: High-intensity interval training

Interventions

Cardiac patients have completed 36 times of exercise training with the exercise frequency of 2-3 times per week. Subjects performed five 3-minute intervals at 80% of VO2peak and each interval was separated by 3-minute exercise at 40% of VO2peak after the warm-up period. The exercise session was terminated by 3-minute cool-down at 30% of VO2peak.

Pre- and Post-HIIT

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure patients, diagnosed according to the Framingham heart failure diagnostic criteria, with stable clinical status for greater than 4 weeks after conservative treatment or intervention were enrolled in the study.

You may not qualify if:

  • Those who were
  • \< 20 years
  • under anti-coagulant therapy
  • unable to exercise \> 1 year owing to non-cardiovascular disease
  • pregnant or plan to be pregnant within one year
  • plan to have cardiac transplant within 6 months
  • uncorrected valvular heart disease related heart failure
  • congenital heart disease related heart failure
  • Other exercise contraindications:
  • unstable angina
  • resting systolic blood pressure\> 200 mmHg or resting diastolic blood pressure\> 110 mmHg
  • orthostatic blood pressure drop (systolic blood pressure drop \> 20 mmHg)。
  • critical aortic stenosis stenosis (peak systolic pressure gradient\> 50 mmHg and aortic valve opening \< 0.75 cm2)。
  • acute fever
  • uncontrolled uncontrolled atrial or ventricular dysrhythmias
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hsu CC, Wang JS, Shyu YC, Fu TC, Juan YH, Yuan SS, Wang CH, Yeh CH, Liao PC, Wu HY, Hsu PH. Hypermethylation of ACADVL is involved in the high-intensity interval training-associated reduction of cardiac fibrosis in heart failure patients. J Transl Med. 2023 Mar 10;21(1):187. doi: 10.1186/s12967-023-04032-7.

MeSH Terms

Conditions

FibrosisVentricular Remodeling

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

July 31, 2019

Study Start

August 1, 2015

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

July 31, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share