Skeletal Muscles in Acute Heart Failure

NCT03102164 | Unknown

• 1 other identifier: UMO-2013/11/D/NZ7/00922
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Heart Decompensation

Keywords

heart failure; decompensation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1,5 months

Study Arms (2)

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.

Procedure: cardiac rehabilitation

Controls

patients treated using standard pharmacotherapy within Center for Heart Disease, Military Clinical Hospital in Wroclaw.

Interventions

cardiac rehabilitation PROCEDURE

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.

cardiac rehabilitation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• patients with acute heart failure (AHF - defined according to the ESC criteria-

You may not qualify if:

• 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
• anemia (hemoglobin \< 9g%)
• active neoplastic process
• liver injury (AST, ALT \> 3 x reference level)
• chronic kidney failure with creatinine clearance \< 30 ml/min.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead

Study Sites (1)

University School of Physical Education in Wroclaw

Wroclaw, Wroclaw, 51-612, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of blood samples for centrifugation, pipetting, frozing and the anaysis of ferritin, iron, albumin + protein + bilirubin, GGT, AST + ALT, hsCRP, NTproBNP, creatinine, complete blood count with smear creatine kinase + enzymes, CK-mass, venous blood gasometry

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kinga Węgrzynowska-Teodorczyk, phd

  University School of Physical Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek Woźniewski, prof

CONTACT

505867875; kingawteodorczyk@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in physiotherapy

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: April 5, 2017
• Study Start: April 21, 2016
• Primary Completion: December 21, 2017
• Study Completion: July 7, 2018
• Last Updated: April 5, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)