NCT05688579Enrolling by invitationPhase 4
Effect of MRA on Cardiovascular Disease in Patients With Hypertension and Hyperaldosteronemia
Effect of Mineralcorticoid Recept Antagonist on Cardiovascular Disease in Patients With Hypertension and Hyperaldosteronemia:A Multicenter Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 18 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Elevated aldosterone causes moderate to severe increase in blood pressure, and leads to various target organ damage including cardiovascular ones. Aldosterone has been considered one of the important risk factors for cardiovascular and cerebrovascular diseases. Currently, the use of mineralocorticoid receptor antagonists(MRA) has been proven to reduce blood pressure levels, but long-term prognostic data are lacking in hypertensive patients. Therefore, the purpose of this clinical trial is to assess the effect of MRA on cardiovascular disease in patients with Hypertension and Hyperaldosteronemia.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 8000 (estimated)
- First submitted
- 5 Jan 2023
- Start date
- 16 Apr 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Nanfang Li
- Diseases
- High blood pressure
- NCT number
- NCT05688579
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 8000
- From 16 Apr 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known secondary cause of hypertension, including pheochromocytoma, primary aldosteronism (adrenal tumor \> 1cm), Cushing's syndrome, renal artery stenosis, renin tumor, connotation of aorta, etc.;
- History of ischemic or hemorrhagic stroke within the last 3 months (not lacunar infarction and transient ischemic attack \[TIA\]).
- History of Hospitalization for myocardial infarction or unstable angina, or coronary revascularization (PCI or CABG) within the last 3 months.
- History of aortic dissection/dissection aneurysm rupture.
- History of NYHA Grade III-IV heart failure or hospitalization Aggravated chronic heart failure upon admission within the last 3 months.
- A history of persistent atrial fibrillation, atrial flutter, or other severe arrhythmias on admission (including sinus delay, diseased sinus, high atrioventricular block, frequent ventricular morning, etc.).
- Patients with serious physical diseases such as malignant tumors and autoimmune diseases.
- Severe cognitive or mental impairment.
- Those who have contraindications or allergies to MRAs.
Lab values
- Severe liver disease or liver dysfunction: AST, ALT, or ALP \> 5ULN (5 times the upper limit of normal), or BIL \> 3ULN (3 times the upper limit of normal).
- End-stage renal disease (ESRD) on dialysis, or estimated glomerular filtration rate (eGFR) \<30 mL/min, or serum creatine \>2.5 mg/dl \[\>221 umol/L\];
Other
- SBP/DBP≥190/120mmHg, DBP\<60 mmHg;
- Pregnant and lactating women.
- Patients with hypoadrenocortical function.
- Participating in other clinical trials.
Who the study is looking for
- Age: 18-75 years old;
- Blood pressure ≥140/90 mmHg, or have taken antihypertensive drugs;
- Plasma aldosterone concentration\> 12ng/ dL;
- Serum potassium \< 4.8mmol/L;
- Signed the written informed consent.
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hypertension Center of People's Hospital of Xinjiang Uygur Autonomous Region Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.