Overview

This trial is active, not recruiting.

Conditions heart failure, diastolic, coronary artery disease, inflammation
Sponsor Federal University of São Paulo
Start date August 2013
End date August 2014
Trial size 50 participants
Trial identifier NCT02649400, 15218913.6.0000.5505

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
Women with diastolic heart failure and previous coronary artery disease

Primary Outcomes

Measure
Functional Capacity
time frame: Up to 1 year after diagnosis
Inflammatory markers
time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Inflammatory Markers
time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment

Secondary Outcomes

Measure
Heart autonomic function
time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Quality of life
time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Pulmonary function
time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Respiratory muscle strength
time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Peripheral muscle strength
time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment

Eligibility Criteria

Female participants from 35 years up to 70 years old.

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.

Additional Information

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
Principal investigator Daniel Figueiredo Alves da Silva, PT
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.