Heart FailureNCT01695421
The Effect of a Five Week Electrical Myostimulation Program in Chronic Diseases
A study testing Medium-frequency alternating current, Burst-modulated alternating current and Functional electrical stimulation in people with Heart Failure, run by University of Brasilia at 1 site in Brazil.
Trial summary
Patients afflicted with Chronic Heart Failure (HF) typically do not maintain stable cardiac function for the remainder of their life and consequently require continuous medical management and intermittent hospital admissions. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Medium-frequency alternating current, Burst-modulated alternating current and Functional electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2012to Jul 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Male or female ≥ 21 and ≤ 80 years of age.
- (2) Current HF symptoms consistent with NYHA class III-IV.
- (3) On stable HF pharmacological therapy for at least one month prior to data collection.
- (4) Left ventricular ejection fraction < 45% documented within 3 months of enrollment (obtained from subjects medical records).
- (5) No planned elective surgery or pacemaker implantation at the time of study initiation.
- (6) Hgb > 8.0 within 1 month of enrollment (obtained from subjects medical records).
- (7) Willingness to provide written informed consent.
Who cannot join
- (1) Inability to provide written informed consent.
- (2) Inability to walk on a treadmill.
- (3) Hemodynamically significant valvular heart disease.
- (4) Unstable angina.
- (5) Acute myocardial infarction within the previous 3 months.
- (6) Obstructive hypertrophic cardiomyopathy.
Show all 15Show fewer
- (7) HF known to be secondary to pericardial disease or uncorrected valvular disease.
- (8) Chronic oxygen therapy.
- (9) Participation in another clinical trial within the past 30 days.
- (10) Participation in a regular exercise within the previous 6 months.
- (11) Previous implantation of a cardiac pacemaker or defibrillator.
- (12) Pregnancy.
- (13) Resting systolic blood pressure > 200 mmHg.
- (14) Failure to demonstrate the ability to operate the EMS unit.
- (15) Failure to be compliant with at least 75% of the EMS training sessions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Brasilia University
Brasília, Federal District, 72220-140
Gerson Cipriano Junior, PhD, +556181907111, cipriano@unb.br
Laura Maria T Neves, Master, +5581431769, lmtomazi@gmail.com
About this study
Official title: Soft-hard Technologies to Assistance and Accessibility in Patients With Chronic Diseases: The Effect of a Five Week Electrical Myostimulation Program.
Patients afflicted with Chronic Heart Failure (HF) typically do not maintain stable cardiac function for the remainder of their life and consequently require continuous medical management and intermittent hospital admissions. Several investigations have demonstrated that electrical muscle stimulation (EMS) produces positive physiologic and psychological adaptations in patients with HF. However not all the EMS modalities were been evaluated on this population or not even were tested based on present recognized gold standard clinical parameters after a short period of treatment. The primary aims of the proposed study is to: Determine the effect of a five week home based of three EMS modalities on prognostics markers, perceived quality of life, muscle force and electrical activity in subjects diagnosed with HF.
Read the detailed description
Introduction: Chronic Heart Failure (HF) patients are a significant health care burden in many countries. Patients afflicted with HF typically do not maintain stable cardiac function for the remainder of their life and consequently require continuous medical management and intermittent hospital admissions. Several investigations have demonstrated that electrical muscle stimulation (EMS) produces positive physiologic and psychological adaptations in patients with HF. However not all the EMS modalities were been evaluated on this population or not even were tested based on present recognized gold standard clinical parameters after a short period of treatment. The impact of use of low frequency (FES) and medium-frequency currents (MAC and BMAC) as EMS on the VE/VCO2 and BNP has likewise not been investigated in patients with HF.
Purposes: The primary aims of the proposed study is to: Determine the effect of a five week home based EMS modalities (a) Functional electrical stimulation (FES), (b) medium-frequency alternating current (MAC) and (c) burst-modulated medium-frequency alternating current (BMAC) training program on the VE/VCO2 slope, Brain Natriuretic Peptide (BNP) level, peak VO2, VO2 at Ventilatory Threshold (VT), perceived quality of life, muscle force and electrical activity in subjects diagnosed with HF (NYHA III and IV). Examine changes in the previously outlined outcome measurements five weeks after cessation of the EMS ((a) FES, (b) MAC and (c) BMAC) training program.
Procedures: We will recruit 40 persons (10 for each EMS modalities and 10 control subjects) diagnosed with HF. A group of control subjects will participate using a sham current. The protocol can be conceptually divided into four sections in the following chronological sequence: (1) baseline assessment (body composition by a bone densitometer X-ray Dual energy X-Ray absortometry - DXA, Resting blood pressure and heart rate, complete blood count and BNP analysis); Living with Heart Failure Questionnaire (MLWHFQ); A physician-supervised maximal aerobic exercise test using a metabolic cart (Vmax, Viasys, USA) (VO2, VE/VCO2, VT); isokinetic peak torque (Biodex System III, Isokinetic Dynamometer, Biodex Medical, Inc., Shirley, NY) and electrical activity (Miotec, Brazil), (2) five week EMS training program (bilateral quadriceps and gastrocnemius for 5 days a week for 1 hour to each muscle group with FES, MAC and BMAC training program), (3) immediate post-training assessment within 5 days of completion of the EMS training program and a (4) final analysis five weeks after cessation of the EMS training program.
- Conditions
- Heart Failure
- Being tested
- Medium-frequency alternating current, Burst-modulated alternating current, Placebo, Functional electrical stimulation
- Keywords
- Transcutaneous Electric Nerve Stimulation, Oxygen Consumption, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium-frequency alternating currentProcedure or surgery
Also called MAC
The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.
Burst-modulated alternating currentProcedure or surgery
Also called BMAC
The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.
PlaceboProcedure or surgery
The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be fixed on 5 mA.
Functional electrical stimulationProcedure or surgery
The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction
| Study group | Role | What they receive |
|---|---|---|
| Functional electrical stimulation | Experimental | Burst modulated alternating rectified current with a 10 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts Receives: Procedure: Functional electrical stimulation |
| Medium-frequency alternating current | Experimental | Burst modulated alternating current with a 2500 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts Receives: Procedure: Medium-frequency alternating current |
| Burst-modulated alternating current | Experimental | Burst modulated alternating current with a 4000 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts. Receives: Procedure: Burst-modulated alternating current |
| Placebo | Placebo comparator | Training with the intensity of 5 mA. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VE/VCO2 slope
Measured: Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.
Secondary outcomes (6)
Peak VO2
Measured: Change from Baseline in Peak VO2 at five and ten weeks post EMS.
VO2 at Ventilatory Threshold
Measured: Change from Baseline in VO2 at ventilatory threshold at five and ten weeks post EMS.
Perceived quality of life
Measured: Change from Baseline in perceived quality od life at five and ten weeks post EMS.
Muscle force
Measured: Change from Baseline in muscle force at five and ten weeks post EMS.
Muscle electrical activity
Measured: Change from Baseline in muscle electrical activity at five and ten weeks post EMS.
Brain Natriuretic Peptide level
Measured: Change from Baseline in Brain Natriuretic Peptide Level at five and ten weeks post EMS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerson Cipriano Jr, University of Brasilia
- Investigators
- Gerson Cipriano Junior, PhD, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695421
- Sponsor's protocol ID
- CSF-01
- Status last verified
- Sep 2012
- First submitted
- 19 Sep 2012
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Myers J, Gademan M, Brunner K, Kottman W, Boesch C, Dubach P. Effects of high-intensity training on indices of ventilatory efficiency in chronic heart failure. J Cardiopulm Rehabil Prev. 2012 Jan-Feb;32(1):9-16. doi: 10.1097/HCR.0b013e3182343bdf.
PubMed 22113369Arena R, Myers J, Aslam SS, Varughese EB, Peberdy MA. Peak VO2 and VE/VCO2 slope in patients with heart failure: a prognostic comparison. Am Heart J. 2004 Feb;147(2):354-60. doi: 10.1016/j.ahj.2003.07.014.
PubMed 14760336Mueller C, Scholer A, Laule-Kilian K, Martina B, Schindler C, Buser P, Pfisterer M, Perruchoud AP. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 Feb 12;350(7):647-54. doi: 10.1056/NEJMoa031681.
PubMed 14960741Vieira PJ, Chiappa AM, Cipriano G Jr, Umpierre D, Arena R, Chiappa GR. Neuromuscular electrical stimulation improves clinical and physiological function in COPD patients. Respir Med. 2014 Apr;108(4):609-20. doi: 10.1016/j.rmed.2013.12.013. Epub 2014 Jan 2.
PubMed 24418570
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft-hard Technologies to Assistance and Accessibility in Patients With Chronic Diseases: The Effect of a Five Week Electrical Myostimulation Program.
- ClinicalTrials.gov ID
- NCT01695421
- Acronym / sponsor ID
- CSF-01
- Conditions
- Heart Failure
- Keywords
- Transcutaneous Electric Nerve Stimulation, Oxygen Consumption, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 28 Sep 2012 (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.
Patients afflicted with Chronic Heart Failure (HF) typically do not maintain stable cardiac function for the remainder of their life and consequently require continuous medical management and intermittent hospital admissions. Several investigations have demonstrated that electrical muscle stimulation (EMS) produces positive physiologic and psychological adaptations in patients with HF. However not all the EMS modalities were been evaluated on this population or not even were tested based on present recognized gold standard clinical parameters after a short period of treatment. The primary aims of the proposed study is to: Determine the effect of a five week home based of three EMS modalities on prognostics markers, perceived quality of life, muscle force and electrical activity in subjects diagnosed with HF.
Detailed description
Introduction: Chronic Heart Failure (HF) patients are a significant health care burden in many countries. Patients afflicted with HF typically do not maintain stable cardiac function for the remainder of their life and consequently require continuous medical management and intermittent hospital admissions. Several investigations have demonstrated that electrical muscle stimulation (EMS) produces positive physiologic and psychological adaptations in patients with HF. However not all the EMS modalities were been evaluated on this population or not even were tested based on present recognized gold standard clinical parameters after a short period of treatment. The impact of use of low frequency (FES) and medium-frequency currents (MAC and BMAC) as EMS on the VE/VCO2 and BNP has likewise not been investigated in patients with HF.
Purposes: The primary aims of the proposed study is to: Determine the effect of a five week home based EMS modalities (a) Functional electrical stimulation (FES), (b) medium-frequency alternating current (MAC) and (c) burst-modulated medium-frequency alternating current (BMAC) training program on the VE/VCO2 slope, Brain Natriuretic Peptide (BNP) level, peak VO2, VO2 at Ventilatory Threshold (VT), perceived quality of life, muscle force and electrical activity in subjects diagnosed with HF (NYHA III and IV). Examine changes in the previously outlined outcome measurements five weeks after cessation of the EMS ((a) FES, (b) MAC and (c) BMAC) training program.
Procedures: We will recruit 40 persons (10 for each EMS modalities and 10 control subjects) diagnosed with HF. A group of control subjects will participate using a sham current. The protocol can be conceptually divided into four sections in the following chronological sequence: (1) baseline assessment (body composition by a bone densitometer X-ray Dual energy X-Ray absortometry - DXA, Resting blood pressure and heart rate, complete blood count and BNP analysis); Living with Heart Failure Questionnaire (MLWHFQ); A physician-supervised maximal aerobic exercise test using a metabolic cart (Vmax, Viasys, USA) (VO2, VE/VCO2, VT); isokinetic peak torque (Biodex System III, Isokinetic Dynamometer, Biodex Medical, Inc., Shirley, NY) and electrical activity (Miotec, Brazil), (2) five week EMS training program (bilateral quadriceps and gastrocnemius for 5 days a week for 1 hour to each muscle group with FES, MAC and BMAC training program), (3) immediate post-training assessment within 5 days of completion of the EMS training program and a (4) final analysis five weeks after cessation of the EMS training program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Functional electrical stimulation | Experimental | Procedure: Functional electrical stimulationBurst modulated alternating rectified current with a 10 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts |
| Medium-frequency alternating current | Experimental | Procedure: Medium-frequency alternating currentBurst modulated alternating current with a 2500 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts |
| Burst-modulated alternating current | Experimental | Procedure: Burst-modulated alternating currentBurst modulated alternating current with a 4000 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts. |
| Placebo | Placebo comparator | Procedure: PlaceboTraining with the intensity of 5 mA. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (1) Male or female ≥ 21 and ≤ 80 years of age.
- (2) Current HF symptoms consistent with NYHA class III-IV.
- (3) On stable HF pharmacological therapy for at least one month prior to data collection.
- (4) Left ventricular ejection fraction < 45% documented within 3 months of enrollment (obtained from subjects medical records).
- (5) No planned elective surgery or pacemaker implantation at the time of study initiation.
Key exclusion criteria (15 listed)
- (1) Inability to provide written informed consent.
- (2) Inability to walk on a treadmill.
- (3) Hemodynamically significant valvular heart disease.
- (4) Unstable angina.
- (5) Acute myocardial infarction within the previous 3 months.
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 |
|---|---|---|
| Medium-frequency alternating currentAlso: MACThe subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction. | Procedure or surgery | Medium-frequency alternating current |
| Burst-modulated alternating currentAlso: BMACThe subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction. | Procedure or surgery | Burst-modulated alternating current |
| PlaceboThe subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be fixed on 5 mA. | Procedure or surgery | Placebo |
| Functional electrical stimulationThe subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction | Procedure or surgery | Functional electrical stimulation |
Primary outcome
VE/VCO2 slope
Time frame: Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.
6 secondary outcomes
Peak VO2
Time frame: Change from Baseline in Peak VO2 at five and ten weeks post EMS.
VO2 at Ventilatory Threshold
Time frame: Change from Baseline in VO2 at ventilatory threshold at five and ten weeks post EMS.
Perceived quality of life
Time frame: Change from Baseline in perceived quality od life at five and ten weeks post EMS.
Muscle force
Time frame: Change from Baseline in muscle force at five and ten weeks post EMS.
Muscle electrical activity
Time frame: Change from Baseline in muscle electrical activity at five and ten weeks post EMS.
Brain Natriuretic Peptide level
Time frame: Change from Baseline in Brain Natriuretic Peptide Level at five and ten weeks post EMS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
- Background: PubMed 22113369Myers J, Gademan M, Brunner K, Kottman W, Boesch C, Dubach P. Effects of high-intensity training on indices of ventilatory efficiency in chronic heart failure. J Cardiopulm Rehabil Prev. 2012 Jan-Feb;32(1):9-16. doi: 10.1097/HCR.0b013e3182343bdf.
- Background: PubMed 14760336Arena R, Myers J, Aslam SS, Varughese EB, Peberdy MA. Peak VO2 and VE/VCO2 slope in patients with heart failure: a prognostic comparison. Am Heart J. 2004 Feb;147(2):354-60. doi: 10.1016/j.ahj.2003.07.014.
- Background: PubMed 14960741Mueller C, Scholer A, Laule-Kilian K, Martina B, Schindler C, Buser P, Pfisterer M, Perruchoud AP. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 Feb 12;350(7):647-54. doi: 10.1056/NEJMoa031681.
- Derived from this study: PubMed 24418570Vieira PJ, Chiappa AM, Cipriano G Jr, Umpierre D, Arena R, Chiappa GR. Neuromuscular electrical stimulation improves clinical and physiological function in COPD patients. Respir Med. 2014 Apr;108(4):609-20. doi: 10.1016/j.rmed.2013.12.013. Epub 2014 Jan 2.
Related trials for Heart Failure
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Recruiting
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
Heart Failure, Heart Failure NYHA Class II
RecruitingObservational study
31P-MRS Myocardial Energetic Phenotyping and Prognosis Across the Cardiac Disease Spectrum
Cardiomyopathies, Heart Failure
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
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.
Gerson Cipriano Junior, PhD principal investigator
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium-frequency alternating current, Burst-modulated alternating current and Functional electrical stimulation in people with Heart Failure, run by University of Brasilia 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 7 inclusion and 15 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 Jun 2013. 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 Gerson Cipriano Junior, PhD (+556181907111, cipriano@unb.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VE/VCO2 slope (time frame: Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.). 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 NCT01695421, which also lists 4 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 10 Jun 2013.