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

Assessment of Functional Capacity, Inflammatory Markers and Autonomic Function in Women With Heart Failure With Preserved Ejection Fraction and Previous Coronary Artery Disease

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Inflammation; Heart Failure, Diastolic

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04024002
    • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Diastolic Heart Failure; Women with diastolic heart failure and previous coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capacity	Measured by the distance walked in the six-minute walking test in meters.	Up to 1 year after diagnosis
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Daniel Figueiredo Alves da Silva, PT, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 8, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Failure; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Inflammation; Heart Failure, Diastolic
• Other Study ID Numbers: 15218913.6.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO