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

Primary Purpose

Hyperaldosteronism, Renal Insufficiency

Status

Withdrawn

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Hydration

About this trial

This is an interventional treatment trial for Hyperaldosteronism focused on measuring primary aldosteronism, surgery therapy, water intake, renal function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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)

Sites / Locations

The First Affilated Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hydration

Control

Arm Description

Participants 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

Outcomes

Primary Outcome Measures

Renal decline

Change in estimated glomerular filtration rate between baseline and 3 months

Secondary Outcome Measures

24-hour urine albumin

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

Rapid renal decline

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

Measured creatinine clearance

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

Copeptin

Change in copeptin among baseline, 3 and 6 months

Blood pressure

Change in blood pressure among baseline, 3 and 6 months

Waist circumference

Change in waist circumference among baseline, 3 and 6 months

Body mass index

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

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

Full Information

NCT ID

NCT04150666

First Posted

November 1, 2019

Last Updated

July 13, 2020

Sponsor

Qifu Li

1. Study Identification

Unique Protocol Identification Number

NCT04150666

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No subjects are willing to participating.

Study Start Date

December 1, 2019 (Anticipated)

Primary Completion Date

May 1, 2020 (Anticipated)

Study Completion Date

December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Qifu Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperaldosteronism, Renal Insufficiency

Keywords

primary aldosteronism, surgery therapy, water intake, renal function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydration

Arm Type

Experimental

Arm Description

Participants 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

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Dietary Supplement

Intervention Name(s)

Hydration

Intervention Description

the same with arm descriptions

Primary Outcome Measure Information:

Title

Renal decline

Description

Change in estimated glomerular filtration rate between baseline and 3 months

Time Frame

Baseline and 3 months

Secondary Outcome Measure Information:

Title

24-hour urine albumin

Description

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

Time Frame

Baseline,3 and 6 months

Title

Rapid renal decline

Description

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

Time Frame

Baseline 3, and 6 months

Title

Measured creatinine clearance

Description

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

Time Frame

Baseline 3, and 6 months

Title

Copeptin

Description

Change in copeptin among baseline, 3 and 6 months

Time Frame

Baseline 3, and 6 months

Title

Blood pressure

Description

Change in blood pressure among baseline, 3 and 6 months

Time Frame

Baseline 3, and 6 months

Title

Waist circumference

Description

Change in waist circumference among baseline, 3 and 6 months

Time Frame

Baseline 3, and 6 months

Title

Body mass index

Description

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

Time Frame

Baseline 3, and 6 months

Title

Renal events

Description

Time Frame

Baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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)

Facility Information:

Facility Name

The First Affilated Hospital of Chongqing Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400016

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23231595

Citation

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.

Results Reference

result

PubMed Identifier

29709927

Citation

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.

Results Reference

result

PubMed Identifier

29987110

Citation

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.

Results Reference

result

PubMed Identifier

29801012

Citation

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.

Results Reference

result

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

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