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HyperaldosteronismNCT04150666

The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)

A study testing Hydration in people with Hyperaldosteronism and Renal Insufficiency, run by Qifu Li at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To investigate whether increasing water intake has renal protective effect on PA patients after surgical treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hyperaldosteronism, Renal Insufficiency
What is being tested?
Hydration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
1 Dec 2019to 1 Dec 2020
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years
  • Able to provide informed consent and willing to complete follow-up visits.
  • Estimated glomerular filtration(eGFR) rate over 60 ml/min/1•73 m²
  • According to the Guideline of Primary Aldosteronism, unilateral PA has been diagnosed and unilateral adrenalectomy has been completed
  • Urine volume can be recorded consciously, and daily drinking water volume is less than 2L/d

Who cannot join

  • Pregnant or breastfeeding
  • Diagnosed with other types of chronic kidney diseases, such as IgA nephropathy, lupus nephritis, etc.
  • History of malignant tumor
  • History of kidney stones in past 5 years
  • Kidney transplant within past six months (or on waiting list)
  • Less than two years life expectancy
Show all 11Show fewer
  • Serum sodium <130 mEq/L without suitable explanation or Serum calcium >2.6 mmol/L without suitable explanation
  • Currently taking hydrochlorothiazide >25 mg/d, indapamide >1.25 mg/d, furosemide >40 mg, or metolazone >2.5 mg/d
  • Poor blood pressure control (systolic pressure>180mmHg or diastolic pressure> 110mmHg)
  • Alcoholics, drug addicts, and people with mental disorders who cannot cooperate
  • Patient is under fluid restriction (<1.5 L a day) for kidney disease, heart failure, or liver disease, AND meets any of the following criteria: i) end stage of the disease (heart left ventricular ejection fraction <40%, NYHA class 3 or 4, or end stage cirrhosis) , ii) hospitalization secondary to ACS,heart failure, stroke,ascites and/or anasarca ,iii)Severe anemia (Hb<60g/L)

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affilated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

Other trials in China

About this study

To investigate whether increasing water intake has renal protective effect on PA patients after surgical treatment.

Read the detailed description

This is a single-center randomized controlled trial study to verify the effect of drinking water on renal function after PA surgery treatment and to follow up the clinical outcomes. We will take short-term follow-up on whether increasing water intake can improve eGFR decline in the early stage of PA patients after surgical treatment and further long-term follow-up to investigate whether increasing drinking water has long-term memory effect to slow down renal function deterioration and improve clinical outcomes. This study will be completed in 1 year.

Being tested
Hydration
Keywords
primary aldosteronism, surgery therapy, water intake, renal function
Medical subject headings
Hyperaldosteronism, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydrationDietary supplement

    the same with arm descriptions

Study groups in NCT04150666
Study groupRoleWhat they receive
HydrationExperimentalParticipants randomized to the hydration-intervention group will be asked to drink 2.0 to 2.5 L of water per day (depending on sex), in addition to usual consumed beverages, for 3 months
Receives: Dietary Supplement: Hydration
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal decline

    Change in estimated glomerular filtration rate between baseline and 3 months

    Measured: Baseline and 3 months

Secondary outcomes (8)

  1. 24-hour urine albumin

    Change in 24-hour urine albumin among baseline, 3 and 6 months

    Measured: Baseline,3 and 6 months

  2. Rapid renal decline

    Proportion with eGFR (estimated glomerular filtration rate) decline >5% among Baseline 3, and 6 months

    Measured: Baseline 3, and 6 months

  3. Measured creatinine clearance

    Change in measured creatinine clearance among baseline, 3 and 6 months

    Measured: Baseline 3, and 6 months

  4. Copeptin

    Change in copeptin among baseline, 3 and 6 months

    Measured: Baseline 3, and 6 months

  5. Blood pressure

    Change in blood pressure among baseline, 3 and 6 months

    Measured: Baseline 3, and 6 months

  6. Waist circumference

    Change in waist circumference among baseline, 3 and 6 months

    Measured: Baseline 3, and 6 months

  7. Body mass index

    Change in body mass index among baseline, 3 and 6 months

    Measured: Baseline 3, and 6 months

  8. Renal events

    Two of the three morning urine UACR\&>300 mg/g Cr, or 24-hour urine protein >300 mg/ 24 h, or serum creatinine level doubled and reached at least 200 μmol/l(2.26 mg/dl), or required renal replacement therapy, or died of renal diseases

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start1 Dec 2019 (estimated)
  3. Primary completion1 May 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Why it stopped: No subjects are willing to participating.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04150666
Sponsor's protocol ID
WIT-PAP Study 2019
Status last verified
Jul 2020
First submitted
1 Nov 2019
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nishikawa T, Omura M, Saito J, Matsuzawa Y, Kino T. Editorial comment from Dr Nishikawa et al. to preoperative masked renal damage in japanese patients with primary aldosteronism: identification of predictors for chronic kidney disease manifested after adrenalectomy. Int J Urol. 2013 Jul;20(7):693-4. doi: 10.1111/iju.12052. Epub 2012 Dec 11. No abstract available.

    PubMed 23231595

  • Nakano Y, Yoshimoto T, Fukuda T, Murakami M, Bouchi R, Minami I, Hashimoto K, Fujii Y, Kihara K, Ogawa Y. Effect of Eplerenone on the Glomerular Filtration Rate (GFR) in Primary Aldosteronism: Sequential Changes in the GFR During Preoperative Eplerenone Treatment to Subsequent Adrenalectomy. Intern Med. 2018 Sep 1;57(17):2459-2466. doi: 10.2169/internalmedicine.0438-17. Epub 2018 Apr 27.

    PubMed 29709927

  • Hundemer GL, Curhan GC, Yozamp N, Wang M, Vaidya A. Renal Outcomes in Medically and Surgically Treated Primary Aldosteronism. Hypertension. 2018 Sep;72(3):658-666. doi: 10.1161/HYPERTENSIONAHA.118.11568.

    PubMed 29987110

  • Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Cuerden MS, Weir MA, Bagga A, Brimble S, Burke A, Muirhead N, Pandeya S, Garg AX. Effect of Coaching to Increase Water Intake on Kidney Function Decline in Adults With Chronic Kidney Disease: The CKD WIT Randomized Clinical Trial. JAMA. 2018 May 8;319(18):1870-1879. doi: 10.1001/jama.2018.4930.

    PubMed 29801012

Questions about this trial

What is this clinical trial studying?

A study testing Hydration in people with Hyperaldosteronism and Renal Insufficiency, run by Qifu Li at 1 site in China.

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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 15 Jul 2020. 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 China. 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 was withdrawn before enrolling participants, so there are no results.

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?

Renal decline (time frame: Baseline and 3 months). 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 NCT04150666, which also lists 4 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 15 Jul 2020.

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