Heart FailureNCT02313714
Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure
A study testing stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec), in people with Heart Failure, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
This study intends to treat patient with congestive heart failure that are maximized their pharmacological treatment and at heart transplant wait list. All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to Dec 2015
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients on waiting list for heart transplant
Who cannot join
- patients that won't accept to participate in the protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Campinas
Campinas, São Paulo, 13100000
Maria Carolina Sacilotto, MsC
About this study
This study intends to treat patient with congestive heart failure that are maximized their pharmacological treatment and at heart transplant wait list.
All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
The outcome will be assessed by the improvement in quality of life and functional capacity.
Read the detailed description
The neuromuscular electrical stimulation (NMES) has been used as adjuvant treatment in patients with end-stage congestive heart failure. Those patients are limited to perform conventional physical activity and adherence to any every day protocols frequency. The aim of this study was evaluated the effect on functional status and quality of life after NMES treatment using Russian stimulation wave solely twice a week during five weeks period in patients waiting for a heart transplant.
Inclusion criteria:
Age between 30 to 80 years old Congestive heart failure in NYHA class III or IV Ejection fraction lower than 35% Stable clinical status Full pharmacologic treatment
Exclusion criteria:
Unstable angina Ventricular arrhythmia intermittent lameness Inferior limb amputation
Protocol Design:
Patients at waiting list for heart transplant will be invited to participate on protocol of NMES using Russian stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec), named NMES group or sham stimulation, named control group. The NMES will be applied for 50 minutes, twice a week on both quadriceps femoral muscles during 7 weeks. The patients will be evaluated every week for distance walked during six minutes walk test (6MWT), heart rate variability, and functional status according to New York Heart Association. All patients were evaluated at the beginning and after completion of the protocol for quality of life with Minnesota Living with Heart Failure Questionnaire (LHFQ).
- Conditions
- Heart Failure
- Being tested
- stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),, Sham
- Keywords
- heart failure, heart transplant, electrical stimulation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),Device
Also called Neuromuscular stimulation
All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
ShamDevice
very low electric muscular stimulation
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular stimulation | Experimental | The patients will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks. Receives: Device: stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec), |
| Sham Group | Placebo comparator | The patients will receive very low electric muscular stimulation with a no biological or clinical effects Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on distance walked in the six minute walk test
Measured: after 7 weeks of first inttervention
Secondary outcomes (1)
Improvement on quality of life
Measured: 7 weeks after first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startSep 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orlando Petrucci, University of Campinas, Brazil
- Investigators
- Maria Carolina Sacilotto, MsC, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313714
- Sponsor's protocol ID
- ENESPHF
- Status last verified
- Dec 2014
- First submitted
- 27 Nov 2013
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT02313714
- Acronym / sponsor ID
- ENESPHF
- Conditions
- Heart Failure
- Keywords
- heart failure, heart transplant, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to treat patient with congestive heart failure that are maximized their pharmacological treatment and at heart transplant wait list.
All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
The outcome will be assessed by the improvement in quality of life and functional capacity.
Detailed description
The neuromuscular electrical stimulation (NMES) has been used as adjuvant treatment in patients with end-stage congestive heart failure. Those patients are limited to perform conventional physical activity and adherence to any every day protocols frequency. The aim of this study was evaluated the effect on functional status and quality of life after NMES treatment using Russian stimulation wave solely twice a week during five weeks period in patients waiting for a heart transplant.
Inclusion criteria:
Age between 30 to 80 years old Congestive heart failure in NYHA class III or IV Ejection fraction lower than 35% Stable clinical status Full pharmacologic treatment
Exclusion criteria:
Unstable angina Ventricular arrhythmia intermittent lameness Inferior limb amputation
Protocol Design:
Patients at waiting list for heart transplant will be invited to participate on protocol of NMES using Russian stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec), named NMES group or sham stimulation, named control group. The NMES will be applied for 50 minutes, twice a week on both quadriceps femoral muscles during 7 weeks. The patients will be evaluated every week for distance walked during six minutes walk test (6MWT), heart rate variability, and functional status according to New York Heart Association. All patients were evaluated at the beginning and after completion of the protocol for quality of life with Minnesota Living with Heart Failure Questionnaire (LHFQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular stimulation | Experimental | Device: stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),The patients will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks. |
| Sham Group | Placebo comparator | Device: ShamThe patients will receive very low electric muscular stimulation with a no biological or clinical effects |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients on waiting list for heart transplant
Key exclusion criteria (1 listed)
- patients that won't accept to participate in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),Also: Neuromuscular stimulationAll patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks. | Device | Neuromuscular stimulation |
| Shamvery low electric muscular stimulation | Device | Sham Group |
Primary outcome
Improvement on distance walked in the six minute walk test
Time frame: after 7 weeks of first inttervention
1 secondary outcome
Improvement on quality of life
Time frame: 7 weeks after first intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Carolina Sacilotto, MsC principal investigator
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec), in people with Heart Failure, run by University of Campinas, Brazil at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Carolina Sacilotto, MsC (+55 19 989464664, carolsaci@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement on distance walked in the six minute walk test (time frame: after 7 weeks of first inttervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2014.