- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02026154
Finding Early Predictors of Myocardial Dysfunction
Finding Early Predictors of Myocardial Dysfunction in Patients With Hypertension - Pilot Study.
연구 개요
상세 설명
The study is to allow for identification of patients with hypertension, in whom an early introduction of pharmacological treatment of heart failure HF should be considered. Evaluation in the detection of asymptomatic myocardial dysfunction will include potential heart failure markers such as: cardiotrophin 1, cystatin C, serum syndecan-4, collagen III N-terminal propeptide [PIIINP], NT-proBNP, IL1RL1 and modern echocardiography methods in order to increase the effectiveness of prevention, diagnosis and treatment optimalization.
Material and study plan about 100 persons (age 30-70 years old) will be included in the study, patients with stage I or II primary hypertension according to the European Society of Hypertension: Group A- 15 patients without symptoms of heart failure Group B- 30 patients with exertional dyspnoea Group C - 40 patients with overt heart failure
In group B (patients with exertional dyspnea/stenocardia) we will include only patients who have undergone CT coronary angiography without any identified changes in the epicardial coronary arteries, which will facilitate answering the presented purpose of research. Patients in groups A and B with normal resting echocardiography and treated with a maximum of 2 antihypertensive drugs (an ACE inhibitor or a sartan as therapy base), according to the following regimen:
ACEI/ARB + diuretic ACEI/ARB + calcium channel antagonist Group C - treatment in accordance with the standards for heart failure. Each patient will be informed about the objectives of the study and give written consent to participate.
After signing informed consent patients will have performed the following tests:
- Interview and documentation analysis,
- Physical examination,
- Electrocardiogram
- Echocardiography at rest and during submaximal exercise on a bicycle ergometer
- Levels of markers: cystatin C, cardiotrophin-1, Procollagen III N-Terminal Propeptide (PIIINP), Syndecan 4 (SDC4) and NT-proBNP, IL1RL1. Each patient will be informed about the objectives of the study and give written consent to participate.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Lodz, 폴란드
- Department of Hypertension, Medical University of Lodz
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- persons (age 30-70 years old) will be included in the study, patients with stage I or II primary hypertension according to the European Society of Hypertension
Exclusion Criteria:
- with coronary artery disease or a history of coronary artery disease (A, B)
- with unstable hypertension
- with a positive stress test
- with NYHA class III-IV heart failure
- after percutaneous or surgical revascularization
- with diabetes
- with GFR < 60
- with hyperthyroidism and hypothyroidism
- active smokers
- with an implanted pacemaker
- with obesity level II and III
- with ECG-arrhythmia
- pregnant and lactating
- with congenital heart disease
- with hemodynamically significant acquired heart defects
- with cardiomyopathies (A,B)
- with cancer
- with anemia
- abusing alcohol or drugs
- with chronic inflammatory and other diseases
- or who have not given their informed consent to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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A, B, C
Group A- 15 patients without symptoms of heart failure - control group Group B- 30 patients with exertional dyspnoea Group C - 40 patients with overt heart failure
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of patients with changes in echocardiography during exercise
기간: 1 year
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Echocardiography at rest and during submaxinal exercise on a bicycle ergometer
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1 year
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2차 결과 측정
결과 측정 |
기간 |
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Changes in biomarkers levels according to clinical symptoms and echocardiography results
기간: 1 year
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Agata Bielecka-Dabrowa, PhD, Medical University of Lodz
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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