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Heart FailureNCT04248894

Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

A study testing Exercise training of High Intensity, Exercise training of Moderate Intensity and Untraining in people with Heart Failure, run by University of Sao Paulo General Hospital at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, the investigators are testing the hypothesis that reduction in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in… Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Heart Failure
What is being tested?
Exercise training of High Intensity, Exercise training of Moderate Intensity and Untraining
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
2 sitesBrazil
Study dates
Jan 2015to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Functional Class II to III of New York Heart Association
  • Left ventricular ejection fraction ≤40%
  • Peak oxygen uptake (V̇O2) <20 ml•kg-1•min-1

Who cannot join

  • Myocardial infarction within three months
  • Unstable angina
  • Acute heart failure
  • Pacemaker
  • Pulmonary disease
  • Chronic renal disease
Show all 11Show fewer
  • Peripheral neuropathy
  • History of stroke
  • Untreated hypo/hyperthyroidism
  • Body mass index (BMI) >30 kg/m2
  • History of smoking

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Heart Institute

    São Paulo, Cerqueira Cesar

  • Heart Institute (InCor)

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

About this study

Official title: The Impact of High-intensity Interval Training Versus Moderate Continuous Training on Neurovascular Control in Patients With Heart Failure

In this study, the investigators are testing the hypothesis that reduction in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF).

Read the detailed description

In this study, the investigators are testing the hypothesis that reductions in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF). To test this hypothesis patients with chronic heart failure (30 - 65 years), left ventricular ejection fraction ≤40%, Functional Classes II-III), are being randomized into exercise with HIIT, MICT or no training (NT) three times/week for 12 weeks. Muscle sympathetic nerve activity is assessed by microneurography. Brachial artery flow-mediated dilation (FMD), blood flow and vascular conductance were assessed by ultrasonography. Blood pressure (BP) and heart rate (HR) by are being measured via finger photoplethysmograph and peak oxygen uptake (V̇O2peak) by a cardiopulmonary exercise test on ergometer cycle for leg. Biopsy samples from the lateral vast of the thigh are being collected for analysis of the intracellular mechanisms in the skeletal muscle. Exercise training is being conducted under supervision at the Heart Institute, School of Medicine, University of São Paulo. Both HIIT and MICT are performed on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 Kcal/session). The intensity of the MICT session is established based on the HR and workload levels corresponding to anaerobic threshold and respiratory compensation point (RCP). The intensity of the HIIT session is established based on the HR and workload levels corresponding to 5% above the RCP. All exercise sessions were performed under the supervision of an exercise physiologist. The patients in the NT group were instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study. All patients are being assessed before (pre) and after (post) both exercise training modes or control, no training.

Conditions
Heart Failure
Being tested
Exercise training of High Intensity, Exercise training of Moderate Intensity, Untraining
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise training of High IntensityOther

    Also called Physical exercise

    High intensity

  • Exercise training of Moderate IntensityOther

    Moderate intensity

  • UntrainingOther

    Sedentary

Study groups in NCT04248894
Study groupRoleWhat they receive
High-intensity interval training (HIIT)ExperimentalHigh-intensity interval training (HIIT) = the exercise of high intensity perform on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 Kcal/session). The intensity of the HIIT session was established based on the HR and workload levels corresponding to 5% above the respiratory compensation point.
Receives: Other: Exercise training of High Intensity
Moderate-intensity continuous training (MICT)ExperimentalModerate-intensity continuous training (MICT) = the exercise of moderate intensity perform on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 Kcal/session). The intensity of the MICT session was established based on the HR and workload levels corresponding to anaerobic threshold and respiratory compensation point
Receives: Other: Exercise training of Moderate Intensity
No trainingSham comparatorThe patients are instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study.
Receives: Other: Untraining

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in muscle sympathetic nerve activity (MSNA)

    MSNA is being assessed by microneurography

    Measured: Baseline and 12 weeks

  2. Change muscle mechanoreceptor sensitivity

    The mechanoreceptor sensitivity is being assessed via passive exercise to the leg

    Measured: Baseline and 12 weeks

  3. Change muscle metaboreceptor sensitivity

    The metaboreceptor sensitivity is being assessed via dynamic exercise to the leg.The exercise intensity is 30% maximum voluntary contraction.

    Measured: Baseline and 12 weeks

  4. Change in chemoreceptor sensitivity

    Hypoxia via 10% oxygen

    Measured: Baseline and 12 weeks

Secondary outcomes (2)

  1. Peripheral vascular function

    Brachial artery flow-mediated dilation is being used to assess the vascular function

    Measured: Baseline and 12 weeks

  2. Skeletal muscle function

    The skeletal muscle function is being assessed in biopsy samples collected in lateral vasts of thigh with needle of biopsy.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study startJan 2015
  3. Primary completionApr 2021
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248894
Sponsor's protocol ID
SDC: 4070/14/050
Status last verified
May 2022
First submitted
23 Jan 2020
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sales ARK, Azevedo LF, Silva TOC, Rodrigues AG, Oliveira PA, Jordao CP, Andrade ACM, Urias U, Guimaraes GV, Bocchi EA, Alves MJNN, Hajjar LA, Filho RK, Grunewald ZI, Martinez-Lemus LA, Padilla J, Negrao CE. High-Intensity Interval Training Decreases Muscle Sympathetic Nerve Activity and Improves Peripheral Vascular Function in Patients With Heart Failure With Reduced Ejection Fraction. Circ Heart Fail. 2020 Aug;13(8):e007121. doi: 10.1161/CIRCHEARTFAILURE.120.007121. Epub 2020 Jul 16. No abstract available.

    PubMed 32673501

  • Xiao P, Wang C, Li J, Su H, Yang L, Wu P, Lewno MT, Liu J, Wang X. COP9 Signalosome Suppresses RIPK1-RIPK3-Mediated Cardiomyocyte Necroptosis in Mice. Circ Heart Fail. 2020 Aug;13(8):e006996. doi: 10.1161/CIRCHEARTFAILURE.120.006996. Epub 2020 Jun 24.

    PubMed 32578441

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training of High Intensity, Exercise training of Moderate Intensity and Untraining in people with Heart Failure, run by University of Sao Paulo General Hospital at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in muscle sympathetic nerve activity (MSNA) (time frame: Baseline and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248894, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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