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

NCT02649400 | Unknown

• 1 other identifier: 15218913.6.0000.5505
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Diastolic; Coronary Artery Disease; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Heart autonomic function

  Up to 1 year after diagnosis on the same day as functional capacity assessment

• Quality of life

  Up to 1 year after diagnosis on the same day as functional capacity assessment

• Pulmonary function

  Up to 1 year after diagnosis on the same day as functional capacity assessment

• Respiratory muscle strength

  Up to 1 year after diagnosis on the same day as functional capacity assessment

• Peripheral muscle strength

  Up to 1 year after diagnosis on the same day as functional capacity assessment

Study Arms (1)

Diastolic Heart Failure

Women with diastolic heart failure and previous coronary artery disease

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04024002, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood and plasma.

MeSH Terms

Conditions

Heart Failure, Diastolic; Coronary Artery Disease; Inflammation

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Figueiredo Alves da Silva, PT

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate Student

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: January 7, 2016
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Last Updated: January 12, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)