ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07294794 (HYPERMARKER) के लिए उच्च रक्तचाप वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension (HYPERMARKER) 400 घर पर मशीन लर्निंग आहार
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07294794 (HYPERMARKER) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो उच्च रक्तचाप से जुड़ा हुआ है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 400 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 19 जनवरी 2026 से शुरू होगा। बर्मिंघम विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 दिसंबर 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 19 दिसंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
High blood pressure (hypertension) affects 1 in 3 adults and can lead to serious health issues like strokes and heart attacks. Medication can lower blood pressure (BP) and reduce complications. Choosing the right medication can be challenging, potentially leading to side effects or poor control.
HYPERMARKER is testing whether providing doctors with additional information when they make a blood pressure prescription ...
और दिखाएँविस्तृत विवरण
Trial design and setting:
HYPERMARKER is a proof-of-concept, pragmatic, adaptive, open-label strategy trial embedded in routine clinical practice with stratified individual patient randomisation. The setting is secondary care, including four hospital sites in four countries (Germany, the Netherlands, Spain and the United Kingdom). Potential participants can be identified at sites from referrals, hospital clinics, am...
और दिखाएँआधिकारिक शीर्षक
Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension (HYPERMARKER)
स्वास्थ्य स्थितियां
उच्च रक्तचापअन्य अध्ययन आईडी
- HYPERMARKER
- RG_24-123
- 354889 (अन्य पहचानकर्ता) (IRAS)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-01-19
अंतिम अद्यतन प्रकाशित
2025-12-19
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-12-31
नामांकन (अनुमानित)
400
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
अभी भर्ती शुरू नहीं
प्रमुख शब्द
metabolomics
pharmacometabolomics
personalised management
blood pressure
machine learning
pharmacometabolomics
personalised management
blood pressure
machine learning
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
क्रॉसओवर (प्रतिच्छेदी अध्ययन)
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
सक्रिय तुलना समूहGroup A Up front prescription based on the usual standard of care, followed by the latest iteration of the pharmacometabolomic approach | देखभाल का मानक (एसओसी) Standard of care for this trial is defined according to the 2024 European Society of Cardiology Guidelines for the management of elevated blood pressure and hypertension. Pharmacometabolomic approach The intervention will combine metabolomic and clinical data using machine learning to provide additional information clinical investigators may utilise in their choice of blood pressure-lowering medication class for individual patients (pharmacometabolomic approach). To allow for an improved approach in the second phase of the trial, the pharmacometabolomic approach will be iterated and refined during the trial as ad...और दिखाएँ |
प्रयोगात्मकGroup B Up-front initial pharmacometabolomic approach, followed by an iterated version of the pharmacometabolomic approach | Pharmacometabolomic approach The intervention will combine metabolomic and clinical data using machine learning to provide additional information clinical investigators may utilise in their choice of blood pressure-lowering medication class for individual patients (pharmacometabolomic approach). To allow for an improved approach in the second phase of the trial, the pharmacometabolomic approach will be iterated and refined during the trial as ad...और दिखाएँ |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Change in home Systolic Blood Pressure | Change in home SBP will be derived from all available patient-measured SBP recordings in the study smartphone application, comparing the intervention and standard of care groups at the end of the first phase of the trial. This includes 1-week of monitoring after enrolment (anticipated minimum of 12 recordings) and at least 4-weeks of monitoring after therapy change (anticipated minimum of 48 recordings). | 5 weeks |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Proportion of participants achieving a target home SBP of 120-129mmHg using the average of the final 3 days of blood pressure measurements. | Comparing the intervention and standard of care groups at the end of the first phase of the trial | 4 weeks |
Proportion of participants reporting any treatment-related adverse effects compiled from the Summary of Product Characteristics from the different classes of anti-hypertensive medications | Comparing the intervention and standard of care groups at the end of the first phase of the trial | 4 weeks |
Proportion of participants reporting withdrawal of an anti-hypertensive medication. | Comparing the intervention and standard of care groups at the end of the first phase of the trial | 4 weeks |
Proportion of participants reporting ≥90% adherence to prescribed anti-hypertensive medication | Comparing the intervention and standard of care groups at the end of the first phase of the trial | 4 weeks |
Rate of change in home SBP using all available SBP measurements, averaged per week. | Comparing the intervention and standard of care groups at the end of the first phase of the trial | 5 weeks |
Change in home diastolic blood pressure derived from all available blood pressure recordings. | Comparing the intervention and standard of care groups at the end of the first phase of the trial | 5 weeks |
Change in home SBP using all available SBP measurements. | Comparing the iterated pharmacometabolomic approach versus the initial pharmacometabolomic approach, and the iterated pharmacometabolomic approach versus initial standard of care | 9 weeks |
Patient-reported treatment-related side effects | Comparing the iterated pharmacometabolomic approach versus the initial pharmacometabolomic approach, and the iterated pharmacometabolomic approach versus initial standard of care | 8 weeks |
Proportion and number of serious adverse events, including all-cause hospitalisation and death | Comparing any pharmacometabolomic approach versus standard of care | 9 weeks |
Proportion and number of healthcare utilisation events, including details on hospitalisation (frequency, cause, type [outpatient, emergency, admission] and length of stay) and primary care interaction (frequency, cause and type [doctor, nurse, other | Comparing any pharmacometabolomic approach versus standard of care | 9 weeks |
Patient-reported quality of life using the EQ-5D-5L summary index score and visual analogue scale. | Comparing any pharmacometabolomic approach versus standard of care | 9 weeks |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Systolic blood pressure ≥140 mmHg on any blood pressure recording method (office, home or ambulatory)
- Age 18 years or older
- Clinical indication for antihypertensive therapy
- Systolic blood pressure ≥180 mmHg on any blood pressure recording method (office, home or ambulatory)
- Potential secondary cause of hypertension, including but not limited to renovascular hypertension, endocrine conditions, chronic kidney disease, coarctation of the aorta or medication related.
- Three or more current anti-hypertensive medications
- Planned intervention for hypertension, such as renal denervation
- Severe kidney disease (estimated glomerular filtration rate <30 mL/min)
- Diagnosis of known heart failure with left ventricular ejection fraction <40%
- Stroke or myocardial infarction within the last 6 months
- Pregnancy, planning for pregnancy, or breastfeeding
- Participant whom the Clinical Investigator deems otherwise ineligible
कोई संपर्क डेटा नहीं।
4 4 देशों में अध्ययन स्थान
University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Renate Schnabel, संपर्क, +49 40 7410-53979, [email protected]
Renate Schnabel, मुख्य अन्वेषक
University Medical Centre Utrecht, Utrecht, Netherlands
Dr Wilko Spiering, संपर्क, +31 8875711 88, [email protected]
Dr Wilko Spiering, मुख्य अन्वेषक
INCLIVA, Biomedical Research Institute, Valencia, Spain
Fernando Martinez-Garcia, संपर्क, +34 679663209, [email protected]
Fernando Martinez-Garcia, मुख्य अन्वेषक
West Midlands
University Hospitals Birmingham, NHS Foundation Trust, Birmingham, West Midlands, United Kingdom
Matthew Chapman, संपर्क, +44 1213718145, [email protected]
Matthew Chapman, मुख्य अन्वेषक