Идёт набор NCT07369856

Spot Analysis of Natriuresis to Guide up- or Down-titration of Diuretic Therapy in Ambulatory Patients With Chronic Heart Failure

Без фазы С лечением Heart Failure Diuretics

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Natriuresis-Guided Up-Titration, Standard care, Natriuresis-Guided Down-Titration, Observational Follow-up.
Кому может быть актуально: Состояния в реестре: Heart Failure, Diuretics. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Spot Analysis of Natriuresis to Guide up- or Down-titration of Diuretic Therapy in Ambulatory Patients With Chronic Heart Failure (SAND-HF)

Обзор

Heart failure is a chronic condition that causes congestion and frequent hospitalizations. Diuretic doses are usually adjusted based on clinical judgment without an objective measure of response. This study will test the feasibility of using point-of-care urine sodium measurements to guide up-titration or down-titration of loop diuretics in ambulatory patients with heart failure. Participants will be assigned to one of three groups based on congestion status. Groups 1 and 2 will be randomized 1:1 to natriuresis-guided therapy or standard care. Group 3 will be observational. The 90-day pilot trial will evaluate feasibility, clinical outcomes, and usability of a urine sodium-guided titration strategy.

Подробное описание

Heart failure is commonly associated with sodium retention and congestion. Loop diuretics are used to relieve congestion but are typically adjusted based on symptoms and clinical judgment. Spot urine sodium concentration is an objective measure of diuretic response that may help personalize treatment. A point-of-care urine sodium sensor provides rapid results and may support effective decongestion or safe reduction of diuretics when appropriate.

This prospective, two-center pilot study includes three clinical groups:

Group 1: Up-titration cohort Patients with clinical congestion or objective evidence of congestion. These participants will be randomized 1:1 to natriuresis-guided up-titration or standard care.

Group 2: Down-titration cohort Stable, euvolemic patients who may safely reduce diuretic therapy. These participants will be randomized 1:1 to natriuresis-guided down-titration or standard care.

Group 3: Observational cohort The first 100 screened patients who do not meet criteria for Groups 1 or 2. These participants will undergo baseline assessments and routine follow-up without intervention.

Urine sodium will be measured at baseline and follow-up visits. Randomized participants will have diuretic doses adjusted based on predefined algorithms. Standard care participants will receive usual clinical management.

The primary aim is to assess feasibility, including recruitment, retention, adherence to sampling procedures, and workflow implementation. Secondary analyses will describe clinical, laboratory, and symptom-based outcomes to inform development of a larger definitive trial.

Вмешательства

Поведенческое Natriuresis-Guided Up-Titration
Diuretic dose and regimen will be increased based on post-diuretic urine sodium concentration measured by a point-of-care sensor. Insufficient natriuresis (\<80 mmol/L) will prompt dose escalation using a predefined algorithm.
Другое Standard care
Participants will receive usual clinical management of loop diuretics at the discretion of the treating physician, without natriuresis-guided adjustment.
Поведенческое Natriuresis-Guided Down-Titration
Loop diuretic doses will be reduced based on urine sodium levels. If urine sodium ≥80 mmol/L, the current dose will be maintained; if \<80 mmol/L, dose will be reduced according to a predefined algorithm. Re-titration criteria include symptomatic weight gain \>2 kg in one week.
Другое Observational Follow-up
Participants who do not meet inclusion criteria for Groups 1 or 2 will undergo baseline urine sodium assessment and routine clinical follow-up. No study-directed titration will occur.

Первичные конечные точки

Change in Clinical Congestion Score (Group 1) [Срок оценки: 90 Days]
Successful Down-Titration of Loop Diuretics (Group 2) [Срок оценки: 90 Days]

Вторичные конечные точки (12)

Dyspnea Visual Analogue Scale (VAS) Area Under the Curve [Срок оценки: 90 Days]
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score [Срок оценки: 90 Days]
Change in New York Heart Association Functional (NYHA) Functional Classification [Срок оценки: Baseline, 30 days, 90 days]
Signs of Volume Overload [Срок оценки: Proportion of participants with clinical signs of volume overload.]
Change in Body Weight [Срок оценки: 90 Days]
Loop Diuretic Use and Dose [Срок оценки: Baseline, 30 days, 90 days]
Guideline-Directed Medical Therapy (GDMT) Use [Срок оценки: 90 days]
NT-proBNP Concentration [Срок оценки: 90 days]
Hemoconcentration [Срок оценки: 90 days]
Change in Creatinine and BUN [Срок оценки: 90 days]
Worsening Renal Function [Срок оценки: 90 days]
Hypokalemia [Срок оценки: 90 Days]

Критерии участия

Критерии включения

Age ≥18 years
Diagnosis of heart failure according to the Universal Definition
Use of loop diuretics
Residing in VCH or PHC regions

Group-specific inclusion:

Group 1: Congestion score ≥5 OR objective congestion; stable furosemide ≥1 week Group 2: NYHA I-II; congestion score <5; no recent HF hospitalization; stable furosemide ≥1 month Group 3: First 100 eligible patients not meeting criteria for Groups 1 or 2