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Early Mineralocorticoid Receptor Antagonist Therapy for Low-Renin Essential Hypertension (EMERALD)

6 listopada 2026 zaktualizowane przez: China National Center for Cardiovascular Diseases

Early Mineralocorticoid Receptor Antagonist Therapy for Low-Renin Essential Hypertension: A Randomized Controlled Study

This study aims to evaluate the efficacy and safety of early initiation of eplerenone, a second-generation mineralocorticoid receptor antagonist, compared with standard antihypertensive treatment in adults with low-renin essential hypertension. The study will assess whether an eplerenone-based treatment strategy provides greater blood pressure reduction, improves blood pressure control, and reduces antihypertensive medication burden compared with standard treatment.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

The EMERALD Trial is a prospective, randomized, open-label, controlled study designed to compare the efficacy and safety of early initiation of a second-generation mineralocorticoid receptor antagonist with standard antihypertensive treatment in adults with low-renin essential hypertension.

A total of 128 eligible participants will be enrolled and randomly assigned in a 1:1 ratio to either an intervention group or a control group.

In the intervention group, participants will receive an eplerenone-based treatment strategy, starting with eplerenone 50 mg once daily. The dose may be gradually increased to 50 mg twice daily, and additional antihypertensive medications may be added according to blood pressure response and treatment tolerability.

In the control group, participants will receive standard antihypertensive treatment based on current clinical guidelines and routine practice. Medication doses may be gradually increased or treatment regimens adjusted according to blood pressure response and treatment tolerability.

In both groups, treatment will be adjusted to achieve an office seated blood pressure below 140/90 mmHg.

Participants will be followed for 24 weeks, with scheduled clinic visits at baseline and weeks 4, 12, and 24, supplemented by remote follow-up between visits.

The primary outcome is the change in mean daytime systolic blood pressure from baseline to week 12, assessed by 24-hour ambulatory blood pressure monitoring. Secondary outcomes include changes in office and ambulatory blood pressure, blood pressure control rates, treatment adjustments, time to blood pressure control, and antihypertensive medication burden assessed using defined daily doses.

Exploratory outcomes include changes in cardiac structure and function, urinary albumin-to-creatinine ratio, and circulating renin and aldosterone levels. Treatment safety will be evaluated throughout the study, with particular attention to hyperkalemia, changes in kidney function, symptomatic hypotension, and other adverse events.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

128

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny, 100037
        • Fuwai Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Age 18 years or older.
  • Either untreated hypertension, defined as mean seated office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, or hypertension currently treated with no more than two antihypertensive agents.
  • Plasma direct renin concentration <12 mU/L after the protocol-specified medication washout: at least 4 weeks for mineralocorticoid receptor antagonists, epithelial sodium channel inhibitors, and other diuretics; and at least 2 weeks for angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and beta-blockers.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥120 mmHg.
  • Current use of mineralocorticoid receptor antagonists or other medications that interfere with renin or aldosterone measurements, including glucocorticoids, oral estrogens, and sodium-glucose cotransporter 2 inhibitors.
  • Pregnancy, breastfeeding, or women of childbearing potential who are not using reliable contraception.
  • Body mass index ≥37.5 kg/m².
  • Serum potassium ≥5.0 mmol/L.
  • Diabetes mellitus with glycated hemoglobin ≥7.5%.
  • Chronic kidney disease with estimated glomerular filtration rate ≤45 mL/min/1.73 m² or urine dipstick protein >2+.
  • New York Heart Association functional class II-IV heart failure, coronary artery disease, or a history of transient ischemic attack, stroke, or atrial fibrillation.
  • Hepatic impairment with alanine aminotransferase or aspartate aminotransferase ≥2 times the upper limit of normal.
  • Secondary hypertension or another condition affecting blood pressure regulation, including licorice abuse, primary hyperparathyroidism, primary aldosteronism, autonomous cortisol secretion, hyperthyroidism, pheochromocytoma, renal artery stenosis, or known monogenic low-renin hypertension.
  • Known allergy or intolerance to any study medication or its components.
  • Inability to tolerate the required medication washout period.
  • Any other condition that, in the investigator's judgment, makes participation unsuitable.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Early Eplerenone-Based Treatment

Participants will receive stepped antihypertensive treatment starting with eplerenone 50 mg orally once daily. Treatment will be intensified as needed by sequentially adding amlodipine 5 mg once daily, increasing eplerenone to 50 mg twice daily, increasing amlodipine to 5 mg twice daily, adding hydrochlorothiazide 12.5 mg once daily, adding doxazosin 4 mg once daily, and increasing hydrochlorothiazide to 25 mg once daily. Participants taking two antihypertensive drugs before washout will generally start with eplerenone plus amlodipine. Treatment adjustments will depend on blood pressure, tolerability, and safety assessments, with a target seated office blood pressure below 140/90 mmHg. Treatment will continue for 24 weeks.
Lek: Eplerenone

Eplerenone will be administered orally at 50 mg once daily as the initial treatment in the experimental arm. The dose may be increased to 50 mg twice daily according to the prespecified treatment algorithm, blood pressure response, tolerability, serum potassium, and kidney function. Treatment will continue for 24 weeks, with dose reduction or interruption when clinically indicated.
Aktywny komparator: Standard Treatment

Participants will receive stepped antihypertensive treatment starting with telmisartan 40 mg orally once daily. Treatment will be intensified as needed by sequentially adding amlodipine 5 mg once daily, increasing telmisartan to 80 mg once daily, increasing amlodipine to 5 mg twice daily, adding hydrochlorothiazide 12.5 mg once daily, adding doxazosin 4 mg once daily, and increasing hydrochlorothiazide to 25 mg once daily. Participants taking two antihypertensive drugs before washout will generally start with telmisartan plus amlodipine. Treatment adjustments will depend on blood pressure, tolerability, and safety assessments, with a target seated office blood pressure below 140/90 mmHg. Treatment will continue for 24 weeks.
Lek: Telmisartan

Telmisartan will be administered orally at 40 mg once daily as the initial treatment in the active comparator arm. The dose may be increased to 80 mg once daily according to the prespecified treatment algorithm, blood pressure response, and tolerability. Treatment will continue for 24 weeks, with dose reduction or interruption when clinically indicated.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Mean Daytime Ambulatory Systolic Blood Pressure at Week 12
Ramy czasowe: Baseline and Week 12

Change in mean daytime systolic blood pressure, measured in mmHg by 24-hour ambulatory blood pressure monitoring, from baseline to Week 12. Mean daytime systolic blood pressure is the average of all valid daytime systolic readings. A valid recording requires at least 70% of scheduled readings, including at least 20 daytime readings and 7 nighttime readings. Change is calculated as the Week 12 value minus the baseline value; a negative value indicates a reduction in blood pressure.
Baseline and Week 12

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Office Systolic Blood Pressure
Ramy czasowe: Baseline, Week 12, and Week 24

Change in seated office systolic blood pressure, measured in mmHg, from baseline to each assessment. Measurements are obtained after at least 5 minutes of seated rest using a standardized upper-arm blood pressure monitor.
Baseline, Week 12, and Week 24
Change From Baseline in Office Diastolic Blood Pressure
Ramy czasowe: Baseline, Week 12, and Week 24

Change in seated office diastolic blood pressure, measured in mmHg, from baseline to each assessment. Measurements are obtained after at least 5 minutes of seated rest using a standardized upper-arm blood pressure monitor.
Baseline, Week 12, and Week 24
Percentage of Participants Achieving Office Blood Pressure Control
Ramy czasowe: Week 12 and Week 24

Percentage of participants with seated office systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg at each assessment.
Week 12 and Week 24
Percentage of Participants Achieving an Office Blood Pressure Response
Ramy czasowe: Baseline, Week 12, and Week 24

Percentage of participants with a reduction from baseline in office systolic blood pressure of at least 10 mmHg, a reduction in office diastolic blood pressure of at least 5 mmHg, or achievement of office blood pressure below 140/90 mmHg.
Baseline, Week 12, and Week 24
Number of Antihypertensive Treatment Adjustments
Ramy czasowe: From randomization through Week 24

Cumulative number of antihypertensive treatment adjustments per participant, including dose increases, addition of a drug, and discontinuation of a drug.
From randomization through Week 24
Time to First Documented Office Blood Pressure Control
Ramy czasowe: From randomization through Week 24

Time, measured in weeks from randomization, to the first study visit at which seated office systolic blood pressure is below 140 mmHg and diastolic blood pressure is below 90 mmHg.
From randomization through Week 24
Mean 24-Hour Ambulatory Systolic Blood Pressure
Ramy czasowe: Week 12 and Week 24

Mean systolic blood pressure, measured in mmHg, calculated from all valid readings during 24-hour ambulatory blood pressure monitoring at each assessment.
Week 12 and Week 24
Mean 24-Hour Ambulatory Diastolic Blood Pressure
Ramy czasowe: Week 12 and Week 24

Mean diastolic blood pressure, measured in mmHg, calculated from all valid readings during 24-hour ambulatory blood pressure monitoring at each assessment.
Week 12 and Week 24
Mean Nighttime Ambulatory Systolic Blood Pressure
Ramy czasowe: Week 12 and Week 24

Mean systolic blood pressure, measured in mmHg, calculated from all valid nighttime readings during ambulatory blood pressure monitoring at each assessment.
Week 12 and Week 24
Mean Nighttime Ambulatory Diastolic Blood Pressure
Ramy czasowe: Week 12 and Week 24

Mean diastolic blood pressure, measured in mmHg, calculated from all valid nighttime readings during ambulatory blood pressure monitoring at each assessment.
Week 12 and Week 24
Mean Daytime Ambulatory Diastolic Blood Pressure
Ramy czasowe: Week 12 and Week 24

Mean diastolic blood pressure, measured in mmHg, calculated from all valid daytime readings during ambulatory blood pressure monitoring at each assessment.
Week 12 and Week 24
Antihypertensive Medication Burden at Achievement of Target Office Blood Pressure
Ramy czasowe: At achievement of target office blood pressure during the 24-week treatment period

Total antihypertensive medication burden required to achieve office blood pressure below 140/90 mmHg, expressed in World Health Organization defined daily dose equivalents. For each drug, the prescribed daily dose is divided by its defined daily dose, and the resulting values are summed across drugs.
At achievement of target office blood pressure during the 24-week treatment period

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Left Ventricular Mass Index
Ramy czasowe: Baseline and Week 24

Change in echocardiographically measured left ventricular mass indexed to body surface area, expressed in g/m².
Baseline and Week 24
Change From Baseline in Left Atrial Volume Index
Ramy czasowe: Baseline and Week 24

Change in left atrial volume indexed to body surface area, measured by echocardiography and expressed in mL/m²
Baseline and Week 24
Change From Baseline in Urinary Albumin-to-Creatinine Ratio
Ramy czasowe: Baseline and Week 24

Change in urinary albumin-to-creatinine ratio, calculated by dividing urinary albumin concentration by urinary creatinine concentration
Baseline and Week 24
Change From Baseline in Plasma Aldosterone Concentration
Ramy czasowe: Baseline and Week 24

Change in plasma aldosterone concentration, measured using a standardized chemiluminescent immunoassay.
Baseline and Week 24
Change From Baseline in Direct Renin Concentration
Ramy czasowe: Baseline and Week 24

Change in direct renin concentration, expressed in mU/L and measured using the DiaSorin LIAISON chemiluminescent immunoassay
Baseline and Week 24
Change From Baseline in Aldosterone-to-Renin Ratio
Ramy czasowe: Baseline and Week 24

Change in the ratio of plasma aldosterone concentration to direct renin concentration
Baseline and Week 24

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

China National Center for Cardiovascular Diseases

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 grudnia 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2027

Ukończenie studiów (Szacowany)

30 kwietnia 2028

Daty rejestracji na studia

Pierwszy przesłany

6 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 listopada 2026

Pierwszy wysłany (Rzeczywisty)

12 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2026-3206

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

The plan for sharing de-identified individual participant data has not yet been determined. The decision will consider participant consent, ethics committee requirements, institutional policies, and applicable data protection regulations. This statement will be updated once a decision has been made.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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