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Complex Pathophysiological Background of Heart Failure Deterioration

2018년 11월 10일 업데이트: Paweł Krzesiński, Military Institute of Medicine, Poland

Multiparametric Assessment of Complex Pathophysiological Background of Heart Failure Deterioration - Relation to Treatment Effects and Prognosis

Preventing heart failure (HF) deterioration is a great challenge for contemporary medicine. The progress course of HF is with increasing frequency of subsequent hospitalizations (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients. The difficulty in treatment of patients with HF deterioration is associated with numerous comorbidities and coexisting complications (i.e. aggravation of ischaemic heart disease, lung diseases, infections, electrolyte disturbances, anaemia, renal failure as well as operations, in particular emergency ones). Our study is aimed to evaluation the complex pathophysiological background related to heart failure deterioration with respect to the effect of applied in-hospital treatment.

연구 개요

상태

완전한

정황

상세 설명

PURPOSE:

Treatment of patients with heart failure (HF) is a great challenge for contemporary medicine. HF frequency in European population is assessed for 0.4 - 2%. This disease is characterized by high morbidity and mortality rate, poor quality of life and the necessity of frequent hospitalizations. Along with the medicine progress, in particular in the scope of acute coronary syndromes treatment, the number of HF patients is constantly growing. The essential problem connected with HF is its progress course and an increasing frequency of subsequent hospitalizations (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients. In the United States approximately 50% of HF patients have been rehospitalized within 6 months from discharge and 70% of these hospitalizations were caused by HF deterioration.The prognosis in HF is closely connected with the progression of the disease defined in accordance with the NYHA (New York Heart Association) functional classification. The yearly mortality rate among each NYHA class is: class 1 - up to 10%, class 2 - 10-20%, class 3 - 20-40%, class 4 - mortality 40-60%. Over half of the patients with symptomatic HF die within 4 years of observation The high in-hospital mortality has been a great problem and results not only from the natural history of HF progression, but also from a number of coexisting complications (i.e. aggravation of ischaemic heart disease, lung diseases, infections, electrolyte disturbances, anaemia, renal failure as well as operations, in particular emergency ones). The optimal schemes of identifying the individual risk are of fundamental importance to guide the safe therapy. Undoubtedly hemodynamic status and its change during hospitalization is one of the main predictive factors of treatment response and occurrences of adverse effects of therapy, i.e. renal function worsening. However, there are no clear guidelines on how to perform safe and effective non-invasive hemodynamic monitoring.

AIMS:

The evaluation of complex pathophysiological features related to heart failure deterioration, including the parameters characterizing i.e. cardiovascular hemodynamics, hydration status, renal failure, iron metabolism and gas exchange, with respect to the effect of applied in-hospital treatment The evaluation of clinical value of the parameters characterizing i.e. cardiovascular hemodynamics, hydration status, renal failure, iron metabolism and gas exchange in prognosis of patients with heart failure deterioration

METHODS:

All the recruited patients will undergo the following assessment:

Clinical examination Laboratory tests, ncluding i.e. white blood cells count, red blood cells count, hemoglobin, hematocrit, mean cell volume (MCV), red cell distribution width (RDW); sodium, potassium, creatinine, estimated glomerular filtration rat (eGFR), urea, cystatin C; fasting glucose; bilirubin; total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, N-terminal of the prohormone brain natriuretic peptide (NT-proBNP); hs-TnT (high sensitive troponin T), iron; ferritin; unsaturated iron binding capacity (UIBC), total iron binding capacity (TIBC), transferrin saturation, soluble transferrin receptor; pH, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), arterial oxygen saturation (SaO2), bicarbonate content (HCO3-), base excess (BE), lactates; thyroid-stimulating hormone (TSH), testosterone, dehydroepiandrosterone sulfate (DHEAS), estradiol Electrocardiogram Echocardiography Chest X-ray Holter-ekg monitoring ambulatory blood pressure monitoring impedance cardiography (including assessment of: resting heart rate (HR), systolic and diastolic blood pressure (SBP and DBP), thoracic fluid content (TFC), cardiac index (CI), stroke index (SI), systemic vascular resistance index (SVRI) bioimpedance (including assessment total body water (TBW), intracellular and extracellular water (ICW, ECW)) applanation tonometry (including assessment of augmentation index (AI) and central pulse pressure (CPP))

연구 유형

관찰

등록 (실제)

102

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Mazovia
      • Warsaw, Mazovia, 폴란드, 04-141
        • Military Institute of Medicine

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Patients with heart failure admitted to the Department of Internal Diseases and Cardiology urgently because of symptomatic heart failure deterioration

설명

Inclusion Criteria:

  • patients of either sex
  • urgent hospitalization caused by deterioration of HF.

Exclusion Criteria:

  • unstable coronary artery disease including myocardial infarct within the last 40 days prior to recruitment
  • stroke within 40 days prior to recruitment
  • cardiac surgery within 90 days prior to recruitment
  • pulmonary embolism
  • severe pulmonary diseases (chronic obstructive pulmonary diseases - stage C/D, uncontrolled asthma, pulmonary hypertension)
  • chronic kidney disease (stage 5 and requiring dialysis)
  • severe inflammatory disease
  • severe mental and physical disorders
  • patients' refusal to participate

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
in-hospital death
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
combined primary endpoint (in-hospital death and/or myocardial infract and/or stroke and/or serious arrhythmia and/or worsening renal function)
기간: 8 days
time frame - assumed mean time of hospitalization
8 days

2차 결과 측정

결과 측정
측정값 설명
기간
myocardial infract
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
stroke (clinical symptoms and confirmed in CT)
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
serious arrhythmia (new onset sustained ventricular tachycardia/fibrillation, supraventricular tachycardia, atrial fibrillation/flutter, sustained bradycardia <40/min)
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
worsening renal function (increase in creatinine 0,3mg/dl according to the definition of AKDI)
기간: 8 days
time frame - assumed mean time of hospitalization
8 days

기타 결과 측정

결과 측정
측정값 설명
기간
significant electrolyte disturbances (K <3,0mmol/l; Na < 120mmol/l and or change in Na 10 mmol/l)
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
symptomatic hypotension (SBP <90 mmHg or change in40 mmHg)
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
hospitalization time (days)
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in NYHA class
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
"diuretic effectiveness ratio" - change in body mass change [%]/diuretics use [mg]
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in HR
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in SBP
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in DBP
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in SI
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in CI
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in TFC
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in SVRI
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in body mass
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in TBW
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in ECW
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in ICW
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in bilirubin
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in eGFR
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in urea
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in hemoglobin
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in hematocrit
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in NTproBNP
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in pH
기간: 8 days
time frame - assumed mean time of hospitalization
8 days
change in lactates
기간: 8 days
time frame - assumed mean time of hospitalization
8 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Pawel Krzesinski, MD, PhD, Military Institute of Medicine

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 12월 1일

기본 완료 (실제)

2017년 6월 1일

연구 완료 (실제)

2018년 6월 1일

연구 등록 날짜

최초 제출

2015년 1월 22일

QC 기준을 충족하는 최초 제출

2015년 1월 30일

처음 게시됨 (추정)

2015년 2월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 11월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 11월 10일

마지막으로 확인됨

2018년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • WIM-0000000213

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심부전에 대한 임상 시험

3
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