Clinical trial NCT04310072: Effects of Neuromuscular Electrostimulation in Patients With Acute Heart Failure
Official title: Effects of Neuromuscular Electrostimulation in Patients With Acute Heart Failure - Results of a Single-centre Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Cardiac rehabilitation
Nouromuscular electrical stimulation
Lead sponsor: Sfantul Pantelimon Emergency Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study team conducted a prospective randomized study to investigate the effects of NMES versus standard therapy on a hospitalized population with AHF. After the patients with AHF were stabilized they were included in the trial and were randomized by a blinded investigator to control group or NMES therapy. At the time of enrollment, patients were clinically evaluated and their associated comorbidities and drug therapy were noted. ECG, echocardiography, 6-minute walk test (6MWT) were performed and laboratory samples were collected including oxidized LDL, NT- proBNP, CK, uric acid, lipid profile and PCR. At the time of discharge, all patients underwent a 6MWT and laboratory samples such as oxidized LDL and NT-proBNP were collected again. During the hospitalization period we monitored any adverse events and tolerance to NMES therapy. At the time of inclusion in the study, patients signed an informed consent form in two copies, one remaining with the patient.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators evaluated the effects of neuromuscular electrical stimulation (NMES) therapy on functional capacity and oxidative stress in patients hospitalized for an episode of acute heart failure (AHF). The NMES therapy was used on top of the conventional rehabilitation program. After randomization the investigators followed the patients by measuring the evolution of functional capacity, oxidative stress and adverse events.

Detailed description: In this program the investigators will include patients with acute heart failure (AHF) with left ventricular ejection fraction (LVEF) lower than 50%, admitted to our clinic.

Patients prior to being included in this research will sign an informed consent form in two samples, one remaining with the patient. This form will contain the study protocol, risks, potential benefits as well as assuring patients that personal data will be used strictly for research purposes. The inclusion and exclusion criteria are presented below. The patients will be randomized into two groups: neuromuscular electrostimulation (NMES) therapy and conventional rehabilitation or a conventional rehabilitation program alone (respiratory gymnastics and strength / endurance exercises in bed).

Patients will receive optimal medical therapy for AHF according to current management guidelines. Patients will complete different questionnaires (Kansas, Beck for Depression). In the first phase, patients will be given a form with questions regarding notions about heart failure and cardiovascular recovery to assess the level of knowledge about their disease.

All patients included will perform the following:

* Clinical evaluation
* ECG
* Biological samples (including NT pro BNP, CK, oxidized LDL plus standard samples)
* Cardiac ultrasound
* 6-minute walk test (6MWT) The duration of NMES therapy will be equal to the duration of hospitalization. At the time of discharge, all patients will undergo a 6MWT and biological samples (NT pro BNP and oxidized LDL) and receive a cardiac rehabilitation program that they will follow at home. They will be given advice on initiating and maintaining a healthy diet, as well as discontinuing smoking if this risk factor is identified.

There will be a telephone visit at 30 days and the investigator will note the vital status and rehospitalizations.

Eligibility criteria: Inclusion Criteria:

* patients with acute heart failure and a LVEF below 50% (echocardiography), admitted consecutively to the cardiology clinic of "Sfantul Pantelimon" Hospital, Bucharest

Exclusion Criteria:

* age under 18 years,
* acute coronary syndrome in the last month,
* recent myocardial revascularization (in the last 6 weeks),
* severe ischemic lesions at the level of the lower limbs,
* life-threatening arrhythmias,
* uncontrolled blood pressure,
* high-grade atrioventricular block,
* acute myocarditis,
* acute pericarditis,
* obstructive hypertrophic cardiomyopathy,
* acute systemic disease,
* deep vein thrombosis,
* severe uncorrected primary valvular disease,
* psychiatric disorders or marked cognitive impairment,
* active neoplastic disorders except basal or squamous cell carcinoma,
* other conditions that in the opinion of the investigator do not allow the participation to the study
* patient's refusal.

Primary outcomes:
measure: evaluate the impact of NMES therapy applied during hospitalization on the functional capacity
timeFrame: up to one month (30 days)
measure: evaluate the impact of NMES therapy on oxidative stress
timeFrame: up to one month (30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Spitalul Sfantul Pantelimon
state: Bucuresti
Study officials:
affiliation: Elias Emergency Hospital
name: Mihai Berteanu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ploesteanu RL, Nechita AC, Turcu D, Manolescu BN, Stamate SC, Berteanu M. Effects of neuromuscular electrical stimulation in patients with heart failure - review. J Med Life. 2018 Apr-Jun;11(2):107-118.