Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention (EDAM)
This prospective randomized open-label study aims to compare the effectiveness of two dual antihypertensive therapy regimens in patients with arterial hypertension and coronary artery disease after elective percutaneous coronary intervention (PCI) with coronary artery stenting.
Patients requiring dual antihypertensive therapy will be randomized to receive either an angiotensin receptor blocker (ARB) combined with a thiazide diuretic or an ARB combined with a dihydropyridine calcium channel blocker.
The study will evaluate blood pressure control, angina symptoms, quality of life, need for treatment intensification, and healthcare utilization during follow-up. Clinical status will be assessed at discharge and during telemedicine follow-up visits at 2 weeks, 4 weeks, and 12 weeks after hospital discharge.
The primary endpoint is the percentage reduction in systolic and diastolic blood pressure. Secondary endpoints include frequency of angina episodes, exercise limitations, patient satisfaction with treatment, and medical consultations during follow-up.
The study is investigator-initiated and plans to enroll at least 207 participants.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Elizaveta Rogozhkina
- 전화번호: +7 (937) 104-73-31
- 이메일: lizarogozkina@gmail.com
연구 장소
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Moscow, 러시아 제국
- 모병
- National Medical Research Center for therapy and preventive medicine
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연락하다:
- Oksana Drapkina
- 전화번호: +7 (495) 212-07-13
- 이메일: drapkina@bk.ru
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 50 to 70 years
- Arterial hypertension
- Coronary artery disease
- Hospitalization for elective percutaneous coronary intervention
- Coronary artery stenting during the current hospitalization
- Requirement for dual antihypertensive therapy
- Treatment with beta-blockers, lipid-lowering therapy, and antiplatelet therapy
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Refusal or inability to provide informed consent
- Acute coronary syndrome
- Active malignancy
- Pulmonary embolism
- Chronic kidney disease stage 4-5
- Type 2 diabetes mellitus
- Contraindications or intolerance to study medications, including bilateral renal artery stenosis, hyperkalemia, hyperuricemia, or gout
- Women of reproductive age
- Permanent or persistent atrial fibrillation
- Planned staged coronary stenting
- Heart failure with reduced ejection fraction
- Any other condition that, in the investigator's opinion, may interfere with participation in the study or interpretation of study results
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: ARB + Thiazide Diuretic
Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic after elective percutaneous coronary intervention.
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Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.
|
|
활성 비교기: ARB + Calcium Channel Blocker
Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker after elective percutaneous coronary intervention.
|
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in office systolic and diastolic blood pressure (mmHg)
기간: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
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Assessment of changes in systolic and diastolic blood pressure values compared with baseline measurements after initiation of dual antihypertensive therapy following elective percutaneous coronary intervention
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2 weeks, 4 weeks, and 12 weeks after hospital discharge
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)
기간: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
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Assessment of exercise limitation using the Physical Limitation domain of the Seattle Angina Questionnaire (SAQ).
Scores range from 0 to 100, with higher scores indicating less physical limitation and better functional status
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2 weeks, 4 weeks, and 12 weeks after hospital discharge
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Angina Frequency Score of the Seattle Angina Questionnaire (SAQ)
기간: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
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Assessment of angina frequency using the Angina Frequency domain of the Seattle Angina Questionnaire (SAQ).
Scores range from 0 to 100, with higher scores indicating fewer angina episodes and better angina control
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2 weeks, 4 weeks, and 12 weeks after hospital discharge
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Participants requiring healthcare utilization during follow-up
기간: 2 weeks, 4 weeks, and 12 weeks after hospital discharge
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Number of participants requiring at least one outpatient visit, emergency department visit, or hospitalization during follow-up
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2 weeks, 4 weeks, and 12 weeks after hospital discharge
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공동 작업자 및 조사자
수사관
- 수석 연구원: Oxana Drapkina, National Medical Research Center for therapy and preventive medicine
- 연구 의자: Olga Dzhioeva, National Medical Research Center for therapy and preventive medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 04-03/26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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