Heart DecompensationNCT03102164
Skeletal Muscles in Acute Heart Failure
An observational study of Heart Decompensation, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
The study will include 30 consecutive patients with acute heart failure (AHF). In 20 patients the investigators will perform cardiologic rehabilitation. In the remaining 10 patients only standard pharmacotherapy will be administered. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Decompensation
- What is being tested?
- cardiac rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 21 Apr 2016to 7 Jul 2018
- Phase
- Observational
- 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
Study population: The study will include 30 patients with acute heart failure (AHF - defined according to the ESC criteria- hospitalized at the Center for Heart Disease, Military Clinical Hospital with Polyclinic in Wroclaw and diagnosed with chronic systolic heart failure at least 6 months prior to the admission.
Who may be able to join
- patients with acute heart failure (AHF - defined according to the ESC criteria-
Who cannot join
- lack of written informed consent
- acute coronary syndrome
- bacterial infection confirmed on the basis of clinical and laboratory criteria
- preexisting chronic respiratory failure
- necessity of mechanical ventilation
- significant arrhythmia and conductivity disorders
Show all 10Show fewer
- anemia (hemoglobin < 9g%)
- active neoplastic process
- liver injury (AST, ALT > 3 x reference level)
- chronic kidney failure with creatinine clearance < 30 ml/min.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University School of Physical Education in Wroclaw
Wroclaw, Wroclaw, 51-612
Kinga Węgrzynowska-Teodorczyk, PhD, 505867875 ext. +48, kingawteodorczyk@gmial.com
About this study
Official title: Evaluation of Skeletal Muscles During Acute Heart Failure
The study will include 30 consecutive patients with acute heart failure (AHF). In 20 patients the investigators will perform cardiologic rehabilitation. In the remaining 10 patients only standard pharmacotherapy will be administered. The cardiologic rehabilitation will follow the protocol used routinely in patients with AHF admitted to the Centre for Heart Disease,Military Hospital in Wroclaw. This protocol includes gradually increasing level of physical exercise (e.g.: respiratory exercises, assisted, active dynamic, and relaxation exercises, as well as short-term isometric exercises and general exercises of very low intensity, short duration and properly adjusted recovery phase).
The following tests will be conducted on the first and last day of hospitalization and 30 days following the discharge:
clinical evaluation (medical interview, routine physical examination, echocardiography, assessment of natriuretic peptides (NT-proBNP), basic laboratory tests with special emphasis on the inflammatory markers and renal and liver parameters); hemodynamic evaluation (i.e. non-invasive evaluation of cardiac output and systemic vascular resistance using of impedance cardiography); evaluation of biomarkers reflecting myocyte-damage (i.e. immunochemical measures of tissue-specific enzymatic isoforms, enabling to distinguish the markers of skeletal muscle damage vs. markers of myocardial injury - e.g. creatine kinase CK, its muscular isozyme CKMM, lactate dehydrogenase 5 LDH5, myoglobin, and carbonic anhydrase III, determined using test based on ELISA). On the first day of hospitalization, as well as on the first, third and last day of rehabilitation (the latter term corresponding to the last day of hospitalization as well) and also 30 days after the discharge, the following tests will be performed (both times: at rest and post-exercise): hemodynamic evaluation, the evaluation of skeletal muscle function (using surface electromyography (sEMG); maximum tonus of the muscles will be determined along with the level of muscular fatigability and its changes over time; the evaluation of muscle tissue perfusion (assessed on the basis of oxygenation level, with non-invasive, direct continuous recording of the perfusion in peripheral tissues by local tissue oximetry, measured by the near-infrared spectroscopy (NIRS). NIRS is based on the absorption of near-infrared waves by oxygenated and reduced haemoglobin. The levels of absorption reflect the degree of tissue oxygenation in a given area of microcirculation. Furthermore, a capillary gasometry (oxygen saturation and lactate concentration) will be determined). Moreover, two functional tests will be performed at the discharge and 30 days after the discharge: the 6-minute walk test and the 30-second "chair stand" test examining the strength endurance of the lower extremities (pertaining to repeated getting up from a chair over a period of 30 seconds).
Read the detailed description
T1. Objective and hypotheses Acute heart failure (AHF) is associated with the disorders of peripheral perfusion, leading to injury of many vital organs. Consequently, each episode of AHF can have a form of multiple organ failure with potential injury and dysfunction of skeletal muscles; however, this latter issue has not been addressed in literature thus far. The aim of this project is to comprehensively evaluate the skeletal muscles (at a functional and tissue level) during acute heart failure. The following hypotheses will be verified:(1) Impaired perfusion of the muscles is reflected by their injury and significant functional abnormalities; (2) Early implemented motor rehabilitation improves perfusion and function of skeletal muscles; This study will demonstrate that skeletal muscles are involved as a component of AHF-related multiple organ failure.
Moreover, study will involve the analysis of the effect of physical exercise sessions on the hemodynamic parameters of patients with AHF (cardiac output, stroke volume, arterial blood pressure, and systemic vascular resistance); this question has not been addressed thus far.
Method The study will include 30 consecutive patients with AHF (resulting from the decompensation of chronic systolic HF). In the case of 20 patients the therapeutic process will include cardiologic rehabilitation, and only standard pharmacotherapy will be administered in another 10 patients. The cardiologic rehabilitation will follow the protocol for patients with AHF used routinely at the Center for Heart Disease, Military Clinical Hospital with Polyclinic in Wroclaw. The protocol includes gradually increasing level of physical exercise: respiratory, assisted, active dynamic, and relaxation exercises, as well as short-term isometric exercises and general strength exercises of very low intensity, short duration and properly adjusted recovery phase.
The following tests will be conducted on the first and last day of hospitalization and 30 days following the discharge:
Clinical evaluation - history taking, routine physical examination, echocardiography, determination of natriuretic peptides (NT-proBNP), basic laboratory tests with special emphasis on the inflammatory markers and renal and liver parameters.
Hemodynamic evaluation - non-invasive determination of cardiac output and systemic vascular resistance by means of impedance cardiography.
Evaluation of myocyte injury markers - immunochemical measurements of tissue-specific enzymatic isoforms will be taken in order to distinguish between the markers of skeletal muscle and myocardial injury. The biomarkers of muscular injury (e.g. creatine kinase CK, its muscular isozyme CKMM, lactate dehydrogenase 5 LDH5, myoglobin, and carbonic anhydrase III) will be determined in serum by means of ELISA.
Moreover, the following tests will be conducted at rest and post-exercise on the first day of hospitalization, as well as on the first, third and last day of rehabilitation (the latter term corresponding to the last day of hospitalization as well) and 30 days after the discharge:
Evaluation of skeletal muscle function will be conducted by means of surface electromyography (sEMG). Maximum tonus of the muscles will be determined along with the level of muscular fatigability and its changes over time. Moreover, two functional tests will be conducted at discharge from the hospital and 30 days thereafter: the 6-minute walk test and the 30-second "chair stand" test examining the strength endurance of the lower body (pertaining to repeated getting up from a chair over a period of 30 seconds).
Evaluation of muscle tissue perfusion (examined indirectly on the basis of oxygenation level) will be conducted with non-invasively by direct continuous recording of perfusion in peripheral tissues by local tissue oximetry, the so-called near-infrared spectroscopy (NIRS). NIRS is based on the absorption of near-infrared waves by oxygenated and reduced hemoglobin. The levels of absorption reflect the degree of tissue oxygenation in a given area of microcirculation. Furthermore, a capillary gasometry (oxygen saturation and lactate concentration) will be determined
- Conditions
- Heart Decompensation
- Being tested
- cardiac rehabilitation
- Keywords
- heart failure, decompensation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac rehabilitationProcedure or surgery
The rehabilitation protocol comprises respiratory, assisted, active dynamic, and relaxation exercises, as well as short-term isometric exercises and general strength exercises of very low intensity, short duration and properly adjusted recovery phase; they are conducted in a lying, sitting, or standing position.
| Study group | Role | What they receive |
|---|---|---|
| cardiac rehabilitation | patients undergoing cardiologic rehabilitation according to the protocol used routinely at the Military Hospital in Wroclaw.The protocol of rehabilitation, adjusted to clinical status, individual needs and physical capability of the patient, includes gradually increasing level of physical exercise. Upon achieving relative stabilization of clinical status and excluding absolute contraindications to physical exercise, usually on the 2nd or 3rd day of hospitalization, the cardiologic rehabilitation is ordered by a physician in charge. The rehabilitation protocol comprises respiratory, assisted, active dynamic,and relaxation exercises, as well as short-term isometric exercises and general strength exercises of very low intensity, short duration and properly adjusted recovery phase;they are conducted in a lying, sitting, or standing position. Receives: Procedure: cardiac rehabilitation | |
| Controls | patients treated using standard pharmacotherapy within Center for Heart Disease, Military Clinical Hospital in Wroclaw. |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of muscle fatigue
We expect that patients from the intervention group will demonstrate reduced muscle fatigability as compared to the controls. Frequency (Hz) and amplitude (mV) of potentials assessed using EMG will serve as a measure of muscle fatigue.
Measured: 1,5 months
improvement of respiratory muscle strength
We expect that patients from the intervention group will demonstrate improved respiratory muscle strength as compared to the controls. Maximal inspiratory and expiratory pressures [both in cm H2O] will serve as measures of respiratory muscle strength.
Measured: 1,5 months
improvement of functional fitness
We expect that patients from the intervention group will demonstrate improved functional fitness as compared to the controls. Results of the six motor tasks in the "Senior Fitness Test" (time (sec.) in Up-and-go; number of repetitions in Chair stand and Arm curl, distance (cm) in Sit-and-reach and Back scratch and distance (m) in six-minute walk test) will serve as a measures of functional fitness.
Measured: 1,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start21 Apr 2016
- Primary completion21 Dec 2017 (estimated)
- Study completion7 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DecompensationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kinga Węgrzynowska-Teodorczyk, Wroclaw University of Health and Sport Sciences
- Investigators
- Kinga Węgrzynowska-Teodorczyk, phd, Principal investigator, University School of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102164
- Sponsor's protocol ID
- UMO-2013/11/D/NZ7/00922
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Skeletal Muscles During Acute Heart Failure
- ClinicalTrials.gov ID
- NCT03102164
- Acronym / sponsor ID
- UMO-2013/11/D/NZ7/00922
- Conditions
- Heart Decompensation
- Keywords
- heart failure, decompensation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 21 Dec 2017 (estimated)
- Study completion
- 7 Jul 2018 (estimated)
- First posted
- 5 Apr 2017 (actual)
- 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.
The study will include 30 consecutive patients with acute heart failure (AHF). In 20 patients the investigators will perform cardiologic rehabilitation. In the remaining 10 patients only standard pharmacotherapy will be administered. The cardiologic rehabilitation will follow the protocol used routinely in patients with AHF admitted to the Centre for Heart Disease,Military Hospital in Wroclaw. This protocol includes gradually increasing level of physical exercise (e.g.: respiratory exercises, assisted, active dynamic, and relaxation exercises, as well as short-term isometric exercises and general exercises of very low intensity, short duration and properly adjusted recovery phase).
The following tests will be conducted on the first and last day of hospitalization and 30 days following the discharge:
clinical evaluation (medical interview, routine physical examination, echocardiography, assessment of natriuretic peptides (NT-proBNP), basic laboratory tests with special emphasis on the inflammatory markers and renal and liver parameters); hemodynamic evaluation (i.e. non-invasive evaluation of cardiac output and systemic vascular resistance using of impedance cardiography); evaluation of biomarkers reflecting myocyte-damage (i.e. immunochemical measures of tissue-specific enzymatic isoforms, enabling to distinguish the markers of skeletal muscle damage vs. markers of myocardial injury - e.g. creatine kinase CK, its muscular isozyme CKMM, lactate dehydrogenase 5 LDH5, myoglobin, and carbonic anhydrase III, determined using test based on ELISA). On the first day of hospitalization, as well as on the first, third and last day of rehabilitation (the latter term corresponding to the last day of hospitalization as well) and also 30 days after the discharge, the following tests will be performed (both times: at rest and post-exercise): hemodynamic evaluation, the evaluation of skeletal muscle function (using surface electromyography (sEMG); maximum tonus of the muscles will be determined along with the level of muscular fatigability and its changes over time; the evaluation of muscle tissue perfusion (assessed on the basis of oxygenation level, with non-invasive, direct continuous recording of the perfusion in peripheral tissues by local tissue oximetry, measured by the near-infrared spectroscopy (NIRS). NIRS is based on the absorption of near-infrared waves by oxygenated and reduced haemoglobin. The levels of absorption reflect the degree of tissue oxygenation in a given area of microcirculation. Furthermore, a capillary gasometry (oxygen saturation and lactate concentration) will be determined). Moreover, two functional tests will be performed at the discharge and 30 days after the discharge: the 6-minute walk test and the 30-second "chair stand" test examining the strength endurance of the lower extremities (pertaining to repeated getting up from a chair over a period of 30 seconds).
Detailed description
T1. Objective and hypotheses Acute heart failure (AHF) is associated with the disorders of peripheral perfusion, leading to injury of many vital organs. Consequently, each episode of AHF can have a form of multiple organ failure with potential injury and dysfunction of skeletal muscles; however, this latter issue has not been addressed in literature thus far. The aim of this project is to comprehensively evaluate the skeletal muscles (at a functional and tissue level) during acute heart failure. The following hypotheses will be verified:(1) Impaired perfusion of the muscles is reflected by their injury and significant functional abnormalities; (2) Early implemented motor rehabilitation improves perfusion and function of skeletal muscles; This study will demonstrate that skeletal muscles are involved as a component of AHF-related multiple organ failure.
Moreover, study will involve the analysis of the effect of physical exercise sessions on the hemodynamic parameters of patients with AHF (cardiac output, stroke volume, arterial blood pressure, and systemic vascular resistance); this question has not been addressed thus far.
Method The study will include 30 consecutive patients with AHF (resulting from the decompensation of chronic systolic HF). In the case of 20 patients the therapeutic process will include cardiologic rehabilitation, and only standard pharmacotherapy will be administered in another 10 patients. The cardiologic rehabilitation will follow the protocol for patients with AHF used routinely at the Center for Heart Disease, Military Clinical Hospital with Polyclinic in Wroclaw. The protocol includes gradually increasing level of physical exercise: respiratory, assisted, active dynamic, and relaxation exercises, as well as short-term isometric exercises and general strength exercises of very low intensity, short duration and properly adjusted recovery phase.
The following tests will be conducted on the first and last day of hospitalization and 30 days following the discharge:
Clinical evaluation - history taking, routine physical examination, echocardiography, determination of natriuretic peptides (NT-proBNP), basic laboratory tests with special emphasis on the inflammatory markers and renal and liver parameters.
Hemodynamic evaluation - non-invasive determination of cardiac output and systemic vascular resistance by means of impedance cardiography.
Evaluation of myocyte injury markers - immunochemical measurements of tissue-specific enzymatic isoforms will be taken in order to distinguish between the markers of skeletal muscle and myocardial injury. The biomarkers of muscular injury (e.g. creatine kinase CK, its muscular isozyme CKMM, lactate dehydrogenase 5 LDH5, myoglobin, and carbonic anhydrase III) will be determined in serum by means of ELISA.
Moreover, the following tests will be conducted at rest and post-exercise on the first day of hospitalization, as well as on the first, third and last day of rehabilitation (the latter term corresponding to the last day of hospitalization as well) and 30 days after the discharge:
Evaluation of skeletal muscle function will be conducted by means of surface electromyography (sEMG). Maximum tonus of the muscles will be determined along with the level of muscular fatigability and its changes over time. Moreover, two functional tests will be conducted at discharge from the hospital and 30 days thereafter: the 6-minute walk test and the 30-second "chair stand" test examining the strength endurance of the lower body (pertaining to repeated getting up from a chair over a period of 30 seconds).
Evaluation of muscle tissue perfusion (examined indirectly on the basis of oxygenation level) will be conducted with non-invasively by direct continuous recording of perfusion in peripheral tissues by local tissue oximetry, the so-called near-infrared spectroscopy (NIRS). NIRS is based on the absorption of near-infrared waves by oxygenated and reduced hemoglobin. The levels of absorption reflect the degree of tissue oxygenation in a given area of microcirculation. Furthermore, a capillary gasometry (oxygen saturation and lactate concentration) will be determined
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiac rehabilitation | – | Procedure: cardiac rehabilitationpatients undergoing cardiologic rehabilitation according to the protocol used routinely at the Military Hospital in Wroclaw.The protocol of rehabilitation, adjusted to clinical status, individual needs and physical capability of the patient, includes gradually increasing level of physical exercise. Upon achieving relative stabilization of clinical status and excluding absolute contraindications to physical exercise, usually on the 2nd or 3rd day of hospitalization, the cardiologic rehabilitation is ordered by a physician in charge. The rehabilitation protocol comprises respiratory, assisted, active dynamic,and relaxation exercises, as well as short-term isometric exercises and general strength exercises of very low intensity, short duration and properly adjusted recovery phase;they are conducted in a lying, sitting, or standing position. |
| Controls | – | –patients treated using standard pharmacotherapy within Center for Heart Disease, Military Clinical Hospital in Wroclaw. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 30 patients with acute heart failure (AHF - defined according to the ESC criteria- hospitalized at the Center for Heart Disease, Military Clinical Hospital with Polyclinic in Wroclaw and diagnosed with chronic systolic heart failure at least 6 months prior to the admission.
Key inclusion criteria (1 listed)
- patients with acute heart failure (AHF - defined according to the ESC criteria-
Key exclusion criteria (10 listed)
- lack of written informed consent
- acute coronary syndrome
- bacterial infection confirmed on the basis of clinical and laboratory criteria
- preexisting chronic respiratory failure
- necessity of mechanical ventilation
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 |
|---|---|---|
| cardiac rehabilitationThe rehabilitation protocol comprises respiratory, assisted, active dynamic, and relaxation exercises, as well as short-term isometric exercises and general strength exercises of very low intensity, short duration and properly adjusted recovery phase; they are conducted in a lying, sitting, or standing position. | Procedure or surgery | cardiac rehabilitation |
Primary outcome
reduction of muscle fatigue
Time frame: 1,5 months
We expect that patients from the intervention group will demonstrate reduced muscle fatigability as compared to the controls. Frequency (Hz) and amplitude (mV) of potentials assessed using EMG will serve as a measure of muscle fatigue.
improvement of respiratory muscle strength
Time frame: 1,5 months
We expect that patients from the intervention group will demonstrate improved respiratory muscle strength as compared to the controls. Maximal inspiratory and expiratory pressures [both in cm H2O] will serve as measures of respiratory muscle strength.
improvement of functional fitness
Time frame: 1,5 months
We expect that patients from the intervention group will demonstrate improved functional fitness as compared to the controls. Results of the six motor tasks in the "Senior Fitness Test" (time (sec.) in Up-and-go; number of repetitions in Chair stand and Arm curl, distance (cm) in Sit-and-reach and Back scratch and distance (m) in six-minute walk test) will serve as a measures of functional fitness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: No
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Aortic Valve Stenosis, Hypertrophy, Left Ventricular
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Exercise, Mediterranean Diet and Inflammation in Heart Failure
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Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
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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.
Kinga Węgrzynowska-Teodorczyk, phd principal investigator
University School of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Decompensation, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
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 10 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 5 Apr 2017. 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 Poland. 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. 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 Marek Woźniewski, prof (505867875 ext. +48, kingawteodorczyk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of muscle fatigue (time frame: 1,5 months). The study lists 3 primary outcomes in all. 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 5 Apr 2017.