Clinical trial NCT02481388: Optoelectronic Pletysmography and Diaphragmatic Thickness in Heart Failure Patients
Official title: Effect of Cardiomegaly Associated With Inspiratory Muscle Weakness on Diaphragm Thickness and Chest Wall Volume Distribution in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure

Brief summary: The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method of the present research, a pilot cross-sectional study was conducted with fourteen (14) patients with heart failure, functional class II and III, clinically stable, with cardiomegaly. Two groups were formed: one group with inspiratory muscle weakness (WG) (maximal inspiratory pressure - MIP \<70% predicted MIP) and a control group without weakness (CG). The pulmonary and respiratory muscle functions were assessed by spirometry and manometer, respectively. Before and after maximal exercise test, optoelectronic plethysmography was performed to evaluate the distribution of volumes, the kinematics and the contraction speed of chest wall muscles. The high-resolution ultrasonography was also used before and after the maximum test for obtaining diaphragmatic thickness


Eligibility criteria: Inclusion Criteria:

* Both sexes, 18-60 years;
* Functional Class II-III according to the New York Heart Association;
* Echocardiography of the last six months showing showing left ventricular ejection fraction (LVEF) ≤ 45% measured by Teichholz method;
* Echocardiography the last six months showing cardiac hypertrophy (Diameter of Left Ventricular Diastolic (LVDD)\> 54 mm, diameter of Systolic Left Ventricular (LVSD)\> 34mm) 30 measured by Teichholz method;
* Optimized by the medical point of view and
* Clinical stability

Exclusion Criteria:

* Unstable angina; myocardial infarction or heart surgery up to three months before the survey;
* Orthopedic diseases, infectious or chronic metabolic diseases;
* The relation between forced expiratory volume in the first second and forced vital capacity (FEV1 / FVC) \<70% of predicted characterizing obstructive respiratory disorder and
* Active smokers.

Primary outcomes:
measure: Diaphragmatic thickness
timeFrame: 30 minutes
measure: Chest Wall tricompartmental volumes
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Laboratório de Fisiologia e Fisioterapia Cardiopulmonar
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Jasiel F do Nascimento Junior, Bch
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.
citation: Brandao DC, Lage SM, Britto RR, Parreira VF, de Oliveira WA Jr, Martins SM, Aliverti A, de Andrade Carvalho L, do Nascimento Junior JF, Alcoforado L, Remigio I, de Andrade AD. Chest wall regional volume in heart failure patients during inspiratory loaded breathing. Respir Physiol Neurobiol. 2012 Mar 15;180(2-3):269-74. doi: 10.1016/j.resp.2011.12.002. Epub 2011 Dec 13.
citation: Aliverti A, Cala SJ, Duranti R, Ferrigno G, Kenyon CM, Pedotti A, Scano G, Sliwinski P, Macklem PT, Yan S. Human respiratory muscle actions and control during exercise. J Appl Physiol (1985). 1997 Oct;83(4):1256-69. doi: 10.1152/jappl.1997.83.4.1256.