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

8. januar 2016 opdateret af: Daniel Figueiredo Alves da Silva, Federal University of São Paulo

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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Women with coronary artery disease diagnosed through angiography and heart failure with preserved ejection fraction diagnosed via ecocardiography.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Diastolic Heart Failure
Women with diastolic heart failure and previous coronary artery disease

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional Capacity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart autonomic function
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Federal University of São Paulo

Efterforskere

  • Ledende efterforsker: Daniel Figueiredo Alves da Silva, PT, Federal University of São Paulo

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2013

Primær færdiggørelse (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

2. december 2015

Først indsendt, der opfyldte QC-kriterier

5. januar 2016

Først opslået (Skøn)

7. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15218913.6.0000.5505

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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