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Optimal Medical Treatment of Difficult-to-treat Hypertension

NCT06275763 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2024-02-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are \<65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs

Conditions

Interventions

DRUG

Phase C: Eplerenone

Participants randomly assigned to this arm take Eplerenone and placebos of Spironolactone and Torasemide

DRUG

Phase C: Spironolactone

Participants randomly assigned to this arm take Spironolactone and placebos of Eplerenone and Torasemide

DRUG

Phase C: Torasemide

Participants randomly assigned to this arm take Torasemide and placebos of Eplerenone and Spironolactone

DRUG

Phase B: Triplixam / Elestar HCT

Replacement of ineffective antihypertensive treatment based on 3 or more antihypertensive drugs (single or dual drug preparations) with a triple single pill combination (SPC) based on optimally combined antihypertensive drugs: perindopril + indapamide + amlodipine (P+I+A) or olmesartan + hydrocholothiazide + amlodipine (O+H+A).

DIAGNOSTIC_TEST

Phase A: Confirmation of uncontrolled hypertension

Confirmation of the true ineffectiveness of antihypertensive therapy based on 3 or more antihypertensive drugs (single or dual drug preparations) using ABPM and home BP measurements.

Sponsors & Collaborators

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Piotr Dobrowolski, Professor · National Institute of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2025-12-01
Completion
2025-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06275763 on ClinicalTrials.gov