Optimal Management Strategy in Patients with Ineffectively Treated Hypertension. OPTIMAL-HT

Team
Dobrowolski

prof. dr hab. n. med. Piotr Dobrowolski

Project Leader- Chief Researcher

Aleksander Prejbisz

prof. dr hab. n. med. Aleksander Prejbisz

Coordinator

Project value
Project value
Value of the Funding

Funding:

The project is funded by:
Medical Research Agency

Competition: ABM/2020/1
Project Number:

2020/ABM/01/00037

Project Name

Optimal Management Strategy in Patients with Ineffectively Treated Hypertension. OPTIMAL-HT

Project Description:

Hypertension (HT) remains the most important modifiable cardiovascular risk factor. Based on the results of NATPOL and WOBASZ studies, it is estimated that there are 11 million people with HT in Poland. Hypertension also constitutes a significant burden for the healthcare system. The 2018 ESC/ESH guidelines emphasize the importance of blood pressure control in the population of people up to 65 years of age, recommending achieving new lower target blood pressure values (120-129/70-79mmHg) in this group of HT patients. These values are associated with the most pronounced reduction in the risk of cardiovascular events.

Project Hypothesis: In patients with uncontrolled hypertension during treatment with 3 or more antihypertensive drugs (single or dual agents), the optimal procedure to achieve new lower target blood pressure values involves changing the current treatment to a compound preparation based on optimally combined three antihypertensive drugs, and in case of further ineffectiveness, the use of an aldosterone antagonist or a loop diuretic.

The above procedure has never been fully verified in a prospective clinical trial, and its application could improve blood pressure control in a significant percentage of HT patients. This is especially important in the studied population of HT patients up to 65 years of age due to the relationship of uncontrolled HT with the impact on reducing the risk of cardiovascular events, renal events, and the development of dementia.

The study results may influence the expansion of registration indications, and consequently, the pursuit of reimbursement for compound preparations based on 3 antihypertensive drugs and evaluated fourth-choice drugs. The data obtained in the project will allow for finding pragmatic solutions to overcome the main problems of achieving target blood pressure values in the Polish population:

  1. The need to increase the degree of patient compliance with recommendations.
  2. Underutilization of compound preparations in NT therapy. Lack of adequate reimbursement for compound preparations.
  3. Non-utilization of potentially effective fourth-choice drugs added to optimal antihypertensive treatment.
  4. The need to reduce the burden on outpatient specialist care.

The presented project has a nationwide scope and will be implemented in 16 centers located in 16 cities representing all provinces.

Part A (Preliminary Phase) (n=2500)

Confirmation of the ineffectiveness of antihypertensive treatment (RR<130/80 mm Hg) based on 3 or more antihypertensive drugs (single or dual preparations) in 24-hour and home measurements.

Part B (Intervention 1) (n=1250)

Replacement of ineffective antihypertensive treatment based on 3 or more antihypertensive drugs (single or dual preparations) with a compound preparation based on 3 optimally combined antihypertensive drugs.

Part C (Intervention 2) (n=450)

Comparison of antihypertensive efficacy and tolerance profile:

– spironolactone

– eplerenone

– torasemide

added as the fourth antihypertensive drug.

Inclusion criteria, part A of the study

– women and men

– age: ≥18 years, less than 65 years

– hypertension diagnosed and treated for at least six months,

– Clinical BP ≥ 130 and/or ≥80 mm Hg

– use of 3 or more antihypertensive drugs, including ACEI/sartan and diuretic (single or dual preparations)

– stable antihypertensive treatment regimen for min. 4 weeks

Additionally, for part B of the study (Intervention 1), patients will be qualified:

– with improper BP control in 24-hour measurement (average daily period ≥ 125 and/or ≥80 mm Hg)

Subsequently, for part C of the study (Intervention 2), patients will be qualified:

– with improper BP control in 24-hour measurement (average daily period ≥ 125 and/or ≥80 mm Hg) after 12 weeks of treatment with a compound preparation based on 3 antihypertensive drugs

– eGFR ≥ 45 ml/min/1.73m2

– potassium level ≤4.8 mmol/L

– aldosterone-to-renin ratio <1:100

Given that the evaluated health project is estimated to potentially concern up to 4 million people in Poland, the implementation of the scheme assessed in the presented project can, through a short-term effect – improving the effectiveness of HT treatment, contribute in the long term to reducing the frequency of consequences of ineffective control of blood pressure: heart attack, stroke, development of dementia, and death, significantly in relation to the population of Poland.

The presented study emphasizes the control of BP and achieving new low target values in middle age – a period in which BP control provides the most pronounced distant benefits – preventing cardiovascular diseases and deaths. It results in prolonging life in health free from cardiovascular diseases (full recovery) and extending life in general (life-saving).

The study is funded by the state budget from the Medical Research Agency, Poland, Project Number: 2020/ABM/01/00037

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