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

Sponsor
Federal University of São Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT02649400
Collaborator
(none)
50
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    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 Start Date :
    Aug 1, 2013
    Actual Primary Completion Date :
    Aug 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Diastolic Heart Failure

    Women with diastolic heart failure and previous coronary artery disease

    Outcome Measures

    Primary Outcome Measures

    1. Functional Capacity [Up to 1 year after diagnosis]

      Measured by the distance walked in the six-minute walking test in meters.

    2. Inflammatory markers [Up to 1 year after diagnosis on the same day as functional capacity assessment]

      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.

    3. Inflammatory Markers [Up to 1 year after diagnosis on the same day as functional capacity assessment]

      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)

    Secondary Outcome Measures

    1. Heart autonomic function [Up to 1 year after diagnosis on the same day as functional capacity assessment]

      Sympathovagal balance assessed by heart rate variability using a heart monitor

    2. Quality of life [Up to 1 year after diagnosis on the same day as functional capacity assessment]

      Quality of life assessed by the Minnesota questionnaire specific for heart failure

    3. Pulmonary function [Up to 1 year after diagnosis on the same day as functional capacity assessment]

      Pulmonary function assessed by spirometry for obtaining values of forced expired volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio

    4. Respiratory muscle strength [Up to 1 year after diagnosis on the same day as functional capacity assessment]

      Respiratory muscle strength assessed by manometer for obtaining maximal inspiratory pressure and maximal expiratory pressure values in cmH2O.

    5. Peripheral muscle strength [Up to 1 year after diagnosis on the same day as functional capacity assessment]

      Peripheral muscle strength assessed by the quadriceps strength using a portable dynamometer in kilogram-force (kgf)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Federal University of Sao Paulo Sao Paulo Brazil 04024002

    Sponsors and Collaborators

    • Federal University of São Paulo

    Investigators

    • Principal Investigator: Daniel Figueiredo Alves da Silva, PT, Federal University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Figueiredo Alves da Silva, Post-graduate Student, Federal University of São Paulo
    ClinicalTrials.gov Identifier:
    NCT02649400
    Other Study ID Numbers:
    • 15218913.6.0000.5505
    First Posted:
    Jan 7, 2016
    Last Update Posted:
    Jan 12, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2016