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
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Sao Paulo, Brazílie, 04024002
- Federal University of São Paulo
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
Diastolic Heart Failure
Women with diastolic heart failure and previous coronary artery disease
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Functional Capacity
Časové okno: Up to 1 year after diagnosis
|
Measured by the distance walked in the six-minute walking test in meters.
|
Up to 1 year after diagnosis
|
|
Inflammatory markers
Časové okno: 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. |
Up to 1 year after diagnosis on the same day as functional capacity assessment
|
|
Inflammatory Markers
Časové okno: 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)
|
Up to 1 year after diagnosis on the same day as functional capacity assessment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Heart autonomic function
Časové okno: 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
|
Up to 1 year after diagnosis on the same day as functional capacity assessment
|
|
Quality of life
Časové okno: 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
|
Up to 1 year after diagnosis on the same day as functional capacity assessment
|
|
Pulmonary function
Časové okno: 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
|
Up to 1 year after diagnosis on the same day as functional capacity assessment
|
|
Respiratory muscle strength
Časové okno: 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.
|
Up to 1 year after diagnosis on the same day as functional capacity assessment
|
|
Peripheral muscle strength
Časové okno: 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)
|
Up to 1 year after diagnosis on the same day as functional capacity assessment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Daniel Figueiredo Alves da Silva, PT, Federal University of São Paulo
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 15218913.6.0000.5505
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .