Assessment of Functional Capacity and Inflammatory Markers in Women With Heart Failure With Preserved Ejection Fraction

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02649400
• Other study ID #: 15218913.6.0000.5505
• Status: Active, not recruiting
• Phase: N/A
• First received: December 2, 2015
• Last updated: January 8, 2016
• Start date: August 2013

Study information

• Verified date: January 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Heart Failure, Diastolic
• Inflammation
• Myocardial Ischemia

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capacity	Measured by the distance walked in the six-minute walking test in meters.	Up to 1 year after diagnosis	Yes
Primary	Inflammatory markers	Inflammatory markers evaluated using specific assays for blood analysis Interleukin (IL) 1 (pg/mL), IL-6 (pg/mL), IL 8 (pg/mL),Tumor Necrosis Factor alpha (pg/mL), Brain Natriuretic Peptide (BNP) (pg/mL), pro-BNP (pg/mL); Lab results will be analysed for each marker and values will be compared to laboratory reference data to identify values out of range.	Up to 1 year after diagnosis on the same day as functional capacity assessment	No
Primary	Inflammatory Markers	Inflammatory markers evaluated using specific assays for blood analysis for high sensitivity C reactive protein (mg/L), alpha-1-acid glycoprotein (mg/dL) and platelets (platelets/cubic millimeters), lactate (mg/dL), uric acid (mg/dL)	Up to 1 year after diagnosis on the same day as functional capacity assessment	No
Secondary	Heart autonomic function	Sympathovagal balance assessed by heart rate variability using a heart monitor	Up to 1 year after diagnosis on the same day as functional capacity assessment	No
Secondary	Quality of life	Quality of life assessed by the Minnesota questionnaire specific for heart failure	Up to 1 year after diagnosis on the same day as functional capacity assessment	No
Secondary	Pulmonary function	Pulmonary function assessed by spirometry for obtaining values of forced expired volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio	Up to 1 year after diagnosis on the same day as functional capacity assessment	No
Secondary	Respiratory muscle strength	Respiratory muscle strength assessed by manometer for obtaining maximal inspiratory pressure and maximal expiratory pressure values in cmH2O.	Up to 1 year after diagnosis on the same day as functional capacity assessment	No
Secondary	Peripheral muscle strength	Peripheral muscle strength assessed by the quadriceps strength using a portable dynamometer in kilogram-force (kgf)	Up to 1 year after diagnosis on the same day as functional capacity assessment	No