Clinical trial NCT02649400: Assessment of Functional Capacity and Inflammatory Markers in Women With Heart Failure With Preserved Ejection Fraction
Official title: Assessment of Functional Capacity, Inflammatory Markers and Autonomic Function in Women With Heart Failure With Preserved Ejection Fraction and Previous Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure, Diastolic
Coronary Artery Disease
Inflammation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with coronary artery disease diagnosed through angiography and heart failure with preserved ejection fraction diagnosed via ecocardiography.

Brief summary: This study assesses the impact of diastolic heart failure on exercise capacity in women who have a previous coronary condition. All the participants will go through the same evaluation.

Detailed description: It is well established that systolic heart failure impacts exercise capacity and quality of life, diastolic heart failure however, is not well documented as a condition that reduces physical performance.

To confirm that patients have a diastolic disfunction an echocardiography will be performed, this will also yield the left ventricle ejection fraction to confirm the preserved ejection fraction heart failure diagnostics.

Exercise capacity will be assessed using the distance walked on the six-minute walking test, performed on a 30m corridor.

Pulmonary function will be assessed with spirometry and values of forced vital capacity and forced expired volume in one second will be recorded and compared to the age-predicted values.

Respiratory strength will be determined by maximal pressure achieved on a respiratory manometer.

Peripheral muscular strength will be assessed with a handheld dynamometer. Knee extension strength of the dominant leg will be recorded.

An echocardiography will be performed to assess systolic and diastolic function and ejection fraction.

Heart autonomic function will be evaluated using a heart rate monitor and a computer software to identify the sympathovagal balance.

Eligibility criteria: Inclusion Criteria:

* Women;
* Aged between 35 and 70 years;
* Coronary artery disease proven by coronary angiography;
* Diastolic heart failure confirmed by recent echocardiography (6 months);
* Left Ventricle ejection fraction of greater than 50%;
* Absence of acute or chronic pulmonary disease;
* Patient clinically compensated;
* Consent form signed for participation in the research

Exclusion Criteria:

* Inability to perform spirometry;
* Presence of acute or chronic pulmonary disease;
* Chronic inflammatory disease, kidney or liver disease;
* Patients using corticosteroids, aspirin or other nonsteroidal anti-inflammatory;
* Clinical or laboratory evidence of infection;
* Morbid obesity;
* Hemodynamic instability at the time of spirometry;
* Patient's or legal guardian request to leave at any time of the study.

Primary outcomes:
measure: Functional Capacity
timeFrame: Up to 1 year after diagnosis
measure: Inflammatory markers
timeFrame: Up to 1 year after diagnosis on the same day as functional capacity assessment
measure: Inflammatory Markers
timeFrame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Secondary outcomes:
measure: Heart autonomic function
timeFrame: Up to 1 year after diagnosis on the same day as functional capacity assessment
measure: Quality of life
timeFrame: Up to 1 year after diagnosis on the same day as functional capacity assessment
measure: Pulmonary function
timeFrame: Up to 1 year after diagnosis on the same day as functional capacity assessment
measure: Respiratory muscle strength
timeFrame: Up to 1 year after diagnosis on the same day as functional capacity assessment
measure: Peripheral muscle strength
timeFrame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Daniel Figueiredo Alves da Silva, PT
role: PRINCIPAL_INVESTIGATOR
References: