Hypertension (HTN)VEX-HDNCT07659197
Usefulness of the VExUS Protocol for Dry-Weight Adjustment in Hemodialysis Patients: The Multicenter VExHD Study
A study testing Increased ultrafiltration and No increase in ultrafiltration in people with Hypertension (HTN) and Hemodialysis, run by Fundación Senefro at 1 site in Spain.
Trial summary
The objective of this prospective observational study is to determine the utility of ultrasonographic assessment using the VExUS protocol for dry weight adjustment in clinically euvolemic patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN), Hemodialysis
- What is being tested?
- Increased ultrafiltration and No increase in ultrafiltration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age who are currently on hemodialysis (more than 90 days since the start of the program)
- A schedule of three days per week at the centers included in the study
- Signed informed consent
Who cannot join
- Clinical signs and symptoms of volume overload
- Patients with liver disease (liver cirrhosis, steatosis, portal vein thrombosis)
- Severe tricuspid regurgitation
- Inability to hold one's breath
- Obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilidad Del Protocolo VExUS en el Ajuste de Peso Ideal de Los Pacientes en hemodiálisis
The objective of this prospective observational study is to determine the utility of ultrasonographic assessment using the VExUS protocol for dry weight adjustment in clinically euvolemic patients undergoing hemodialysis.
The primary hypothesis is that the assessment of venous congestion by ultrasound may help identify patients who can tolerate increased ultrafiltration, thereby improving blood pressure control.
The comparison group will consist of patients who do not meet the criteria for venous congestion according to the VExUS protocol.
In patients meeting the criteria for venous congestion, the ultrafiltration volume during hemodialysis will be increased.
Read the detailed description
Patients receiving maintenance hemodialysis face persistent challenges in achieving optimal volume status, and intravascular congestion is a major contributor to cardiovascular morbidity. Traditional clinical signs have limited diagnostic accuracy for detecting volume excess, as noted in the protocol: "the evaluation of volume status based on classical symptoms and signs… has shown low sensitivity and specificity". Point-of-care ultrasonography (PoCUS) offers a non-invasive and reproducible method to assess congestion, yet the role of the VExUS protocol in guiding dry-weight adjustment has not been systematically evaluated in this population.
This prospective, multicenter study incorporates a structured, repeated assessment of venous congestion over a five-week period. On the mid-week dialysis day, all participants undergo a modified VExUS examination (excluding intrarenal veins), lung ultrasound, and multifrequency bioimpedance. These assessments are repeated weekly for four consecutive weeks, enabling longitudinal characterization of venous congestion and its relationship with ultrafiltration tolerance, interdialytic weight gain, and blood pressure.
Patients classified as congestive according to VExUS Doppler patterns receive a standardized ultrafiltration increase of 0.3 L during the following week, consistent with the protocol statement: "patients classified as congestive will have ultrafiltration increased… reducing dry weight by 0.3 kg during that week". Hemodynamic tolerance is monitored at each dialysis session, including intradialytic blood pressure, symptoms, and the need for nursing interventions. If the patient tolerates the increased ultrafiltration, the adjusted post-dialysis weight is incorporated into the prescribed dry weight. Patients without evidence of venous congestion continue with standard ultrafiltration based solely on interdialytic weight gain.
The study also includes a comprehensive biomarker program. Baseline blood samples are collected on the first mid-week session and repeated at week five, measuring cardiac biomarkers (NT-proBNP, CA-125, troponin), markers of congestion (bioADM, sST2, CD146), and inflammatory mediators (FGF-23, IL-6, IL-18, TNF-α, among others). Samples requiring specialized analysis are processed and stored according to predefined procedures. These data will help explore biological correlates of venous congestion and their evolution during follow-up.
Additional weekly assessments include lung ultrasound quantification of B-lines, bioimpedance-derived fluid status, and pre-dialysis blood pressure. Intradialytic parameters such as relative blood volume changes and hemodynamic tolerance are recorded at every session. At the end of follow-up, changes in prescribed dry weight, blood pressure, and antihypertensive therapy are evaluated.
The primary objective is to determine whether VExUS can serve as a useful adjunct for dry-weight adjustment in hemodialysis patients. Secondary analyses will examine the impact of congestion-guided ultrafiltration on blood pressure, fluid status, and biomarker trajectories. All clinical decisions outside the predefined ultrafiltration adjustment follow routine practice, and the study does not introduce additional therapeutic interventions.
This structured, repeated-measure design may help clarify the dynamic relationship between venous congestion, ultrafiltration tolerance, and volume management in hemodialysis, and inform future strategies for integrating PoCUS-based vascular assessment into standard nephrology care.
- Conditions
- Hypertension (HTN), Hemodialysis
- Being tested
- Increased ultrafiltration, No increase in ultrafiltration
- Keywords
- vexus, Hypertension, hemodialysis, dry weight
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased ultrafiltrationBehavioural
In patients meeting the predefined ultrasonographic criteria for venous congestion, the prescribed dry weight will be reduced by 0.3 kg per week, resulting in a corresponding increase in the ultrafiltration volume during hemodialysis sessions.
No increase in ultrafiltrationBehavioural
In patients who do not meet the predefined ultrasonographic criteria for venous congestion, the ultrafiltration prescription will remain unchanged.
| Study group | Role | What they receive |
|---|---|---|
| congestive | Experimental | Patients who have increased ultrafiltration Receives: Behavioral: Increased ultrafiltration |
| Non-congested | Active comparator | Patients in whom ultrafiltration was not increased Receives: Behavioral: No increase in ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dry weight
To evaluate the usefulness of the VExUS protocol in dry-weight adjustment in hemodialysis patients.
Measured: 4 weeks
Secondary outcomes (1)
Change in systolic blood pressure
Change in systolic and diastolic blood pressure associated with ultrafiltration practices during the study period.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Senefro
- Sponsor type
- University, hospital or other
- Collaborators
- SOMANE (MADRID SOCIETY OF NEPHROLOGY)
- Responsible party
- Principal investigator, Patrica De Sequera, Fundación Senefro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659197
- Sponsor's protocol ID
- 48681309
- Other IDs
- Beca de investigación, Beca de investigación
- Acronym
- VEX-HD
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be analyzed at this center and has also been anonymized using a code
Publications
Zoccali C, Torino C, Mallamaci F, Sarafidis P, Papagianni A, Ekart R, Hojs R, Klinger M, Letachowicz K, Fliser D, Seiler-Mussler S, Lizzi F, Wiecek A, Miskiewicz A, Siamopoulos K, Balafa O, Slotki I, Shavit L, Stavroulopoulos A, Covic A, Siriopol D, Massy ZA, Seidowsky A, Battaglia Y, Martinez-Castelao A, Polo-Torcal C, Coudert-Krier MJ, Rossignol P, Fiaccadori E, Regolisti G, Hannedouche T, Bachelet T, Jager KJ, Dekker FW, Tripepi R, Tripepi G, Gargani L, Sicari R, Picano E, London GM. A randomized multicenter trial on a lung ultrasound-guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk. Kidney Int. 2021 Dec;100(6):1325-1333. doi: 10.1016/j.kint.2021.07.024. Epub 2021 Aug 19.
PubMed 34418415Loutradis C, Papadopoulos CE, Sachpekidis V, Ekart R, Krunic B, Papadopoulou D, Papagianni A, Mallamaci F, Zoccali C, Sarafidis PA. Lung ultrasound-guided dry-weight reduction and echocardiographic changes in clinically euvolemic hypertensive hemodialysis patients: 12-month results of a randomized controlled trial. Hellenic J Cardiol. 2022 Mar-Apr;64:1-6. doi: 10.1016/j.hjc.2021.11.002. Epub 2021 Nov 29.
PubMed 34856379Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: 10.1681/ASN.2012100990. Epub 2013 Feb 28.
PubMed 23449536Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM. Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol. 2015 Mar;26(3):724-34. doi: 10.1681/ASN.2014020222. Epub 2014 Sep 30.
PubMed 25270068Loutradis C, Sarafidis PA, Ekart R, Tsouchnikas I, Papadopoulos C, Kamperidis V, Alexandrou ME, Ferro CJ, Papagianni A, London G, Mallamaci F, Zoccali C. Ambulatory blood pressure changes with lung ultrasound-guided dry-weight reduction in hypertensive hemodialysis patients: 12-month results of a randomized controlled trial. J Hypertens. 2021 Jul 1;39(7):1444-1452. doi: 10.1097/HJH.0000000000002818.
PubMed 34074973Pandhi P, Ter Maaten JM, Anker SD, Ng LL, Metra M, Samani NJ, Lang CC, Dickstein K, de Boer RA, van Veldhuisen DJ, Voors AA, Sama IE. Pathophysiologic Processes and Novel Biomarkers Associated With Congestion in Heart Failure. JACC Heart Fail. 2022 Sep;10(9):623-632. doi: 10.1016/j.jchf.2022.05.013.
PubMed 36049813Romero-Gonzalez G, Manrique J, Slon-Roblero MF, Husain-Syed F, De la Espriella R, Ferrari F, Bover J, Ortiz A, Ronco C. PoCUS in nephrology: a new tool to improve our diagnostic skills. Clin Kidney J. 2022 Sep 12;16(2):218-229. doi: 10.1093/ckj/sfac203. eCollection 2023 Feb.
PubMed 36755847Kaptein MJ, Kaptein EM. Inferior Vena Cava Collapsibility Index: Clinical Validation and Application for Assessment of Relative Intravascular Volume. Adv Chronic Kidney Dis. 2021 May;28(3):218-226. doi: 10.1053/j.ackd.2021.02.003.
PubMed 34906306Ma L, Zhao S. Risk factors for mortality in patients undergoing hemodialysis: A systematic review and meta-analysis. Int J Cardiol. 2017 Jul 1;238:151-158. doi: 10.1016/j.ijcard.2017.02.095. Epub 2017 Feb 22.
PubMed 28341375
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilidad Del Protocolo VExUS en el Ajuste de Peso Ideal de Los Pacientes en hemodiálisis
- ClinicalTrials.gov ID
- NCT07659197
- Acronym / sponsor ID
- VEX-HD / 48681309
- Conditions
- Hypertension (HTN), Hemodialysis
- Keywords
- vexus, Hypertension, hemodialysis, dry weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fundación SenefroUniversity, hospital or other
- Collaborators
- SOMANE (MADRID SOCIETY OF NEPHROLOGY)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective observational study is to determine the utility of ultrasonographic assessment using the VExUS protocol for dry weight adjustment in clinically euvolemic patients undergoing hemodialysis.
The primary hypothesis is that the assessment of venous congestion by ultrasound may help identify patients who can tolerate increased ultrafiltration, thereby improving blood pressure control.
The comparison group will consist of patients who do not meet the criteria for venous congestion according to the VExUS protocol.
In patients meeting the criteria for venous congestion, the ultrafiltration volume during hemodialysis will be increased.
Detailed description
Patients receiving maintenance hemodialysis face persistent challenges in achieving optimal volume status, and intravascular congestion is a major contributor to cardiovascular morbidity. Traditional clinical signs have limited diagnostic accuracy for detecting volume excess, as noted in the protocol: "the evaluation of volume status based on classical symptoms and signs… has shown low sensitivity and specificity". Point-of-care ultrasonography (PoCUS) offers a non-invasive and reproducible method to assess congestion, yet the role of the VExUS protocol in guiding dry-weight adjustment has not been systematically evaluated in this population.
This prospective, multicenter study incorporates a structured, repeated assessment of venous congestion over a five-week period. On the mid-week dialysis day, all participants undergo a modified VExUS examination (excluding intrarenal veins), lung ultrasound, and multifrequency bioimpedance. These assessments are repeated weekly for four consecutive weeks, enabling longitudinal characterization of venous congestion and its relationship with ultrafiltration tolerance, interdialytic weight gain, and blood pressure.
Patients classified as congestive according to VExUS Doppler patterns receive a standardized ultrafiltration increase of 0.3 L during the following week, consistent with the protocol statement: "patients classified as congestive will have ultrafiltration increased… reducing dry weight by 0.3 kg during that week". Hemodynamic tolerance is monitored at each dialysis session, including intradialytic blood pressure, symptoms, and the need for nursing interventions. If the patient tolerates the increased ultrafiltration, the adjusted post-dialysis weight is incorporated into the prescribed dry weight. Patients without evidence of venous congestion continue with standard ultrafiltration based solely on interdialytic weight gain.
The study also includes a comprehensive biomarker program. Baseline blood samples are collected on the first mid-week session and repeated at week five, measuring cardiac biomarkers (NT-proBNP, CA-125, troponin), markers of congestion (bioADM, sST2, CD146), and inflammatory mediators (FGF-23, IL-6, IL-18, TNF-α, among others). Samples requiring specialized analysis are processed and stored according to predefined procedures. These data will help explore biological correlates of venous congestion and their evolution during follow-up.
Additional weekly assessments include lung ultrasound quantification of B-lines, bioimpedance-derived fluid status, and pre-dialysis blood pressure. Intradialytic parameters such as relative blood volume changes and hemodynamic tolerance are recorded at every session. At the end of follow-up, changes in prescribed dry weight, blood pressure, and antihypertensive therapy are evaluated.
The primary objective is to determine whether VExUS can serve as a useful adjunct for dry-weight adjustment in hemodialysis patients. Secondary analyses will examine the impact of congestion-guided ultrafiltration on blood pressure, fluid status, and biomarker trajectories. All clinical decisions outside the predefined ultrafiltration adjustment follow routine practice, and the study does not introduce additional therapeutic interventions.
This structured, repeated-measure design may help clarify the dynamic relationship between venous congestion, ultrafiltration tolerance, and volume management in hemodialysis, and inform future strategies for integrating PoCUS-based vascular assessment into standard nephrology care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| congestive | Experimental | Behavioral: Increased ultrafiltrationPatients who have increased ultrafiltration |
| Non-congested | Active comparator | Behavioral: No increase in ultrafiltrationPatients in whom ultrafiltration was not increased |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age who are currently on hemodialysis (more than 90 days since the start of the program)
- A schedule of three days per week at the centers included in the study
- Signed informed consent
Key exclusion criteria (5 listed)
- Clinical signs and symptoms of volume overload
- Patients with liver disease (liver cirrhosis, steatosis, portal vein thrombosis)
- Severe tricuspid regurgitation
- Inability to hold one's breath
- Obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased ultrafiltrationIn patients meeting the predefined ultrasonographic criteria for venous congestion, the prescribed dry weight will be reduced by 0.3 kg per week, resulting in a corresponding increase in the ultrafiltration volume during hemodialysis sessions. | Behavioural | congestive |
| No increase in ultrafiltrationIn patients who do not meet the predefined ultrasonographic criteria for venous congestion, the ultrafiltration prescription will remain unchanged. | Behavioural | Non-congested |
Primary outcome
Change in Dry weight
Time frame: 4 weeks
To evaluate the usefulness of the VExUS protocol in dry-weight adjustment in hemodialysis patients.
1 secondary outcome
Change in systolic blood pressure
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 34418415Zoccali C, Torino C, Mallamaci F, Sarafidis P, Papagianni A, Ekart R, Hojs R, Klinger M, Letachowicz K, Fliser D, Seiler-Mussler S, Lizzi F, Wiecek A, Miskiewicz A, Siamopoulos K, Balafa O, Slotki I, Shavit L, Stavroulopoulos A, Covic A, Siriopol D, Massy ZA, Seidowsky A, Battaglia Y, Martinez-Castelao A, Polo-Torcal C, Coudert-Krier MJ, Rossignol P, Fiaccadori E, Regolisti G, Hannedouche T, Bachelet T, Jager KJ, Dekker FW, Tripepi R, Tripepi G, Gargani L, Sicari R, Picano E, London GM. A randomized multicenter trial on a lung ultrasound-guided treatment strategy in patients on chronic hemodialysis with high cardiovascular risk. Kidney Int. 2021 Dec;100(6):1325-1333. doi: 10.1016/j.kint.2021.07.024. Epub 2021 Aug 19.
- Background: PubMed 34856379Loutradis C, Papadopoulos CE, Sachpekidis V, Ekart R, Krunic B, Papadopoulou D, Papagianni A, Mallamaci F, Zoccali C, Sarafidis PA. Lung ultrasound-guided dry-weight reduction and echocardiographic changes in clinically euvolemic hypertensive hemodialysis patients: 12-month results of a randomized controlled trial. Hellenic J Cardiol. 2022 Mar-Apr;64:1-6. doi: 10.1016/j.hjc.2021.11.002. Epub 2021 Nov 29.
- Background: PubMed 23449536Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: 10.1681/ASN.2012100990. Epub 2013 Feb 28.
- Background: PubMed 25270068Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM. Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol. 2015 Mar;26(3):724-34. doi: 10.1681/ASN.2014020222. Epub 2014 Sep 30.
- Background: PubMed 34074973Loutradis C, Sarafidis PA, Ekart R, Tsouchnikas I, Papadopoulos C, Kamperidis V, Alexandrou ME, Ferro CJ, Papagianni A, London G, Mallamaci F, Zoccali C. Ambulatory blood pressure changes with lung ultrasound-guided dry-weight reduction in hypertensive hemodialysis patients: 12-month results of a randomized controlled trial. J Hypertens. 2021 Jul 1;39(7):1444-1452. doi: 10.1097/HJH.0000000000002818.
- Background: PubMed 36049813Pandhi P, Ter Maaten JM, Anker SD, Ng LL, Metra M, Samani NJ, Lang CC, Dickstein K, de Boer RA, van Veldhuisen DJ, Voors AA, Sama IE. Pathophysiologic Processes and Novel Biomarkers Associated With Congestion in Heart Failure. JACC Heart Fail. 2022 Sep;10(9):623-632. doi: 10.1016/j.jchf.2022.05.013.
- Background: PubMed 36755847Romero-Gonzalez G, Manrique J, Slon-Roblero MF, Husain-Syed F, De la Espriella R, Ferrari F, Bover J, Ortiz A, Ronco C. PoCUS in nephrology: a new tool to improve our diagnostic skills. Clin Kidney J. 2022 Sep 12;16(2):218-229. doi: 10.1093/ckj/sfac203. eCollection 2023 Feb.
- Background: PubMed 34906306Kaptein MJ, Kaptein EM. Inferior Vena Cava Collapsibility Index: Clinical Validation and Application for Assessment of Relative Intravascular Volume. Adv Chronic Kidney Dis. 2021 May;28(3):218-226. doi: 10.1053/j.ackd.2021.02.003.
- Background: PubMed 28341375Ma L, Zhao S. Risk factors for mortality in patients undergoing hemodialysis: A systematic review and meta-analysis. Int J Cardiol. 2017 Jul 1;238:151-158. doi: 10.1016/j.ijcard.2017.02.095. Epub 2017 Feb 22.
- Individual participant dataSharing planned: No. The data will be analyzed at this center and has also been anonymized using a code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased ultrafiltration and No increase in ultrafiltration in people with Hypertension (HTN) and Hemodialysis, run by Fundación Senefro at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dry weight (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07659197, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.