NCT07238400Toboroz2. fázis
Cardiac Effects of Mineralocorticoid Receptor Antagonism After Hypertensive Disorders of Pregnancy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 20.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to determine if the medication eplerenone yields greater improvements in coronary microvascular function than chlorthalidone in women who experienced hypertension during pregnancy and subsequently developed chronic hypertension. The main Aims are: * To test the hypothesis that, in women with prior pregnancy-induced hypertension, current chronic hypertension, and concentric LV remodeling, eplerenone improves coronary microvascular function vs. chlorthalidone. * To test the hypothesis that, in women with prior pregnancy-induced hypertension, current chronic hypertension, and concentric LV remodeling, eplerenone improves early mitral diastolic inflow velocity/annular relaxation velocity vs. chlorthalidone. Participants will: * First receive pre-treatment with Amlodipine for 12 weeks prior to beginning the study medication (participants who are already receiving amlodipine monotherapy for at least 3 months prior to randomization will proceed directly to the baseline visit). * Start study treatment which involves daily self-administration of two oral capsules (eplerenone + potassium placebo or chlorthalidone + potassium), each taken once a day, for a total of 336 doses over 48 weeks. * Attend study visits at weeks 2, 12, 24, 36, and 48. These visits will involve collecting information, measuring blood pressure, and gathering blood and urine samples. Echocardiography (cardiac ultrasound), eye exam, and cardiac PET/CT scan will be performed during the baseline and week 48 visits.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 90 (tervezett)
- Első benyújtás
- 2025. nov. 11.
- Kezdés
- 2026. márc. 20.
- Elsődleges befejezés
- 2029. márc. 16.
- Fő szponzor
- Massachusetts General Hospital
- Betegségek
- Magas vérnyomás
- NCT-szám
- NCT07238400
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 90
- 2026. márc. 20. és az elsődleges befejezés (2029. márc. 16.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Use of a mineralocorticoid receptor antagonist (MRA) or amiloride within the past 3 months or more than 30 days within the previous 12 months.
- Use of oral contraceptives, progestin depot or implant (note: progestin-containing IUD is permitted), or menopausal hormone therapy.
- Participants using GLP-1 receptor agonists (GLP-1RA) are eligible only if they have received continuous treatment with the same GLP-1RA agent at an unchanged maintenance dose for ≥12 months prior to enrollment. Dose changes, agent switches, or formulation changes within the 12 months preceding enrollment are not permitted. Temporary interruptions of ≤4 consecutive weeks (e.g., due to supply issues or procedural holds) are allowed, provided the same agent and dose are resumed. At the time of enrollment, there must be no planned or anticipated GLP-1RA dose escalation, dose reduction, or discontinuation. Initiation of GLP-1RA therapy after randomization is not permitted. Dose changes during follow-up are discouraged unless clinically required.
Más betegség
- Clinical atherosclerotic cardiovascular disease, including coronary, cerebrovascular, or peripheral artery disease.
- Diabetes mellitus.
- Any moderate or greater valvular heart disease.
- Other serious medical illnesses or concerns about protocol adherence/mortality risk within 15 months.
Laborértékek
- LV ejection fraction <40% or history of clinical heart failure (reduced or preserved ejection fraction).
- eGFR <60 mL/min/1.73 m².
- Urine microalbumin/creatinine ratio >300 mg/g at screening.
- Abnormal electrolytes, hemoglobin, liver function tests, or TSH at screening or baseline.
- History of hypersensitivity or intolerance to calcium channel blockers, thiazides, or MRAs.
Egyéb
- Planned pregnancy, current pregnancy, or lactation.
- Systolic BP >150 mmHg and/or diastolic BP >95 mmHg while on antihypertensives, or systolic BP >160 mmHg and/or diastolic BP >100 mmHg if untreated.
- BMI >45 kg/m².
- Hypertrophic or other genetic cardiomyopathy.
- Plasma renin activity <1 mg/mL/hour and aldosterone >20 ng/dL (suggestive of primary aldosteronism).
- Active substance abuse.
- Participation in another interventional clinical study.
- Use of allopurinol.
- Use of lithium.
Kiket keres a vizsgálat
- Female with a history of de novo preeclampsia, gestational hypertension, or preeclampsia superimposed on chronic hypertension (defined by ACOG criteria) in a singleton pregnancy.
- At least one year from last pregnancy.
- Current chronic hypertension (stage 1 or greater).
- Evidence of concentric left ventricular (LV) remodeling, defined as relative LV wall thickness >0.42, with or without LV hypertrophy.
- Age 18-65 years at time of randomization.
Életkor a regiszterben: 18 év – 65 év · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Massachusetts General Hospital | Boston | Egyesült Államok | Toboroz |
| Brigham and Women's Hospital | Boston | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.