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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Sao Paulo、ブラジル、04024002
- Federal University of São Paulo
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Diastolic Heart Failure
Women with diastolic heart failure and previous coronary artery disease
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional Capacity
時間枠：Up to 1 year after diagnosis
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Measured by the distance walked in the six-minute walking test in meters.
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Up to 1 year after diagnosis
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Inflammatory markers
時間枠：Up to 1 year after diagnosis on the same day as functional capacity assessment
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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
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Inflammatory Markers
時間枠：Up to 1 year after diagnosis on the same day as functional capacity assessment
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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)
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Up to 1 year after diagnosis on the same day as functional capacity assessment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Heart autonomic function
時間枠：Up to 1 year after diagnosis on the same day as functional capacity assessment
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Sympathovagal balance assessed by heart rate variability using a heart monitor
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Up to 1 year after diagnosis on the same day as functional capacity assessment
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Quality of life
時間枠：Up to 1 year after diagnosis on the same day as functional capacity assessment
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Quality of life assessed by the Minnesota questionnaire specific for heart failure
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Up to 1 year after diagnosis on the same day as functional capacity assessment
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Pulmonary function
時間枠：Up to 1 year after diagnosis on the same day as functional capacity assessment
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Pulmonary function assessed by spirometry for obtaining values of forced expired volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio
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Up to 1 year after diagnosis on the same day as functional capacity assessment
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Respiratory muscle strength
時間枠：Up to 1 year after diagnosis on the same day as functional capacity assessment
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Respiratory muscle strength assessed by manometer for obtaining maximal inspiratory pressure and maximal expiratory pressure values in cmH2O.
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Up to 1 year after diagnosis on the same day as functional capacity assessment
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Peripheral muscle strength
時間枠：Up to 1 year after diagnosis on the same day as functional capacity assessment
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Peripheral muscle strength assessed by the quadriceps strength using a portable dynamometer in kilogram-force (kgf)
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Up to 1 year after diagnosis on the same day as functional capacity assessment
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協力者と研究者
捜査官
- 主任研究者：Daniel Figueiredo Alves da Silva, PT、Federal University of São Paulo
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
冠動脈疾患の臨床試験
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