CClinicalTrials.gg
Active, not recruitingNCT07127640Updated Aug 17, 2025

Effect of an Aerobic Exercise Session on Cardiovascular and Autonomic Parameters of Adults With Hypertrophic Cardiomyopathy

An interventional study of Exercise in Cardiomyopathy, Hypertrophic, Physical Exercise and Autonomic Nervous System, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
  • Registered 10 months after the study started (first participant enrolled Jul 2024, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

Hypertrophic cardiomyopathy is a genetic heart disease with symptoms that may include dyspnea and fatigue predominantly on exertion, with or without chest pain, palpitations, syncope/presyncope and sudden cardiac death, mostly in young individuals, often without symptoms. Due to the higher cardiovascular risk described for individuals with hypertrophic cardiomyopathy, it is extremely important to create non-pharmacological strategies that can minimize the evolution of cardiovascular risk factors found in this population. The objective of the study will be to evaluate the effect of an aerobic exercise session on the ratio between the low frequency (LF) and high frequency (HF) bands of heart rate variability, endothelial function through flow-mediated dilation and systolic and diastolic blood pressure during the 24-hour period in adult individuals with hypertrophic cardiomyopathy. The study design will be a randomized crossover clinical trial with individuals aged 18 to 59 years, of both sexes, randomized by lottery and divided into two groups: Exercise group and control group without exercise. An exercise stress test will be performed and on a new date the individuals will perform a supervised session of moderate-intensity aerobic exercise on a horizontal stationary bicycle for 50 minutes or will remain seated in an air-conditioned room for the same period of time. Subsequently, the procedures will be crossed. It is expected to find improvements in the parameters of endothelial function, autonomic modulation and 24-hour blood pressure in adult individuals with non-obstructive hypertrophic cardiomyopathy undergoing a session of aerobic physical exercise when compared to a control session without exercise.

02

Conditions studied

  • Cardiomyopathy, Hypertrophic
  • Physical Exercise
  • Autonomic Nervous System
  • Endothelium
  • Blood Pressure
03

In context

Cardiomyopathy, Hypertrophic

347 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 110 are open to participants now.

This study's planned enrollment of 10 is below the median of 59 across 171 interventional studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The study population will consist of individuals aged between 18 and 59 years with HCM diagnosed via ICFUC medical records.

Exclusion criteria

Exclusion Criteria:

  • Individuals with a history of exercise-induced arrhythmias, a history of aborted sudden death, and the presence of an implantable cardioverter defibrillator will be excluded from the sample. Those with LVOT obstruction at rest ≥50 mmHg on medical therapy, recent septal reduction therapy, pregnancy, class IV symptoms in the New York Heart Association (NYHA) functional classification78, hypotensive response to exercise (drop in systolic BP >20 mmHg in relation to the resting value or during exercise) will also be excluded. Concomitantly, those with systolic dysfunction of left ventricular ejection fraction \<50%, myocardial infarction, or previous stroke will be excluded. Hypertensive patients, those with orthopedic limitations, or any physical or mental limitation that prevents them from performing physical exercises will also be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Exercise

    An aerobic exercise session on a recumbent exercise bike with a 5-minute warm-up period, followed by a 40-minute cool-down period and ending with a 5-minute cool-down at decreasing speed.

    Other: Exercise

  • No intervention
    Control

    The control session will consist of the individual remaining seated for 50 minutes in an air-conditioned room.

Interventions

  • OtherExercise

    An aerobic exercise session on a recumbent exercise bike with a 5-minute warm-up period, followed by a 40-minute cool-down period and ending with a 5-minute cool-down at decreasing speed.

06

What researchers measure

Primary outcomes

  1. Assessment of autonomic system function

    Ratio between the low frequency (LF) and high frequency (HF) bands of heart rate variability by electrocardiogram

    Time frame: From enrollment to the end of treatment at 2 weeks

Secondary outcomes

  1. Assessment of endothelial function

    Flow-mediated dilation (FMD) by high-resolution Doppler ultrasound images of the brachial artery.

    Time frame: From enrollment to the end of treatment at 2 weeks

  2. Blood pressure assessment

    Ambulatory Blood Pressure Monitoring

    Time frame: From enrollment to the end of treatment at 2 weeks

07

Study locations

1 site
  • Instituto de Cardiologia do Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia (IC/FUC)o Grande do Sul / Fundação Universitária de Cardiologia (IC/FUC)
    Porto Alegre, Rio Grande do Sul, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07127640
Lead sponsor
Instituto de Cardiologia do Rio Grande do Sul
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Jul 29, 2024
Primary completion
Dec 2025 (estimated)
Completion
Jun 2026 (estimated)
Last update
Aug 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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