Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01970176
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2013-10-22
Brief Title:
Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy Aim2
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Define in Preclinical Systolic Dysfunction PSD With Renal Dysfunction the Cardiorenal and Humoral Actions of Chronic Type V Phosphodiesterase PDEV Inhibition
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Aim2
Brief Summary:
To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral response to acute sodium loading in subjects with preclinical systolic dysfunction PSD and renal kidney dysfunction
Detailed Description:
At the consent visit a blood draw will be done also a the 6 minute walk will be done to determine eligibility and a physical exam along with vital signs height and weight will be done Twenty-four hour urine collection will be obtained one day prior to the active study day
Prior to initiation of the study subjects will be stabilized for at least one week on a no added salt diet 120 milliequivalents of sodiumsalt per day mEq Naday which will be maintained throughout the study period
Subjects will be admitted to the Clinical Research Unit CRUon the evening before the active study day They will be able to order a no-added salt meal and will not have anything to eat after midnight until the last renal clearance blood draw the next day Bladder scan will be carried out to assess for urine retention On the active study day subjects take their medications upon awakening however diabetics will hold their diabetic medications until after the last renal clearance test then they will be able to order a regular diet meal and take their diabetic medications Subjects will be asked to drink 5mlKg milliliters per kilogram of body weight of water to insure sufficient urinary flow A priming dose calculated according to body size of Iothalamate to measure glomerular filtration rate GFR and para-amino-hippurate PAH to measure effective renal plasma flow ERPF is infused followed by a constant rate IV sustaining dose calculated according to estimated kidney function of Iothalamate or PAH The subjects will be asked to empty their bladder spontaneously every thirty minutes Throughout the study at the end of each 30-minute clearance period subjects will be asked to drink an amount of water equivalent to the sum of the blood losses and the urinary flow After an equilibration period of 45 minutes a 30-minute baseline renal clearance will be carried out
Blood pressure will be measured at 20-minute intervals by using automatic blood pressure cuff and heart rate will be continuously monitored by electrocardiography Echocardiography will be performed during these baseline clearances to determine left atrial LA and Left Ventricular LVvolumes and systolic and diastolic function
After the baseline clearance the acute saline load will be administered normal saline 09 025 mlkgmin for 1 hour During the 1 hour saline load one 30-minute clearance as outlined above will be repeated with the subjects in supine position after which a second 30-minute clearance will be repeated with the subject sitting or the head of the bed up As above blood samples are collected midway during each clearance and urine samples are obtained every 30 minutes Echocardiography will be repeated immediately after the end of the saline infusion
At the completion of the baseline renal clearance periods and response to acute sodium load subjects will be randomized to Tadalafil or placebo Subjects will be randomized in a 21 fashion
All subjects will take oral Tadalafil 5 mg or placebo once a day The blood pressure will be checked prior to administering the drugThereafter both blood pressure and heart rate will continue to be monitored for the next 4 hours If after the first dose of study drug if patients systolic blood pressure is 85 mmHg systolic and has symptoms of hypotension eg lightheadedness dizziness feeling faint blurred vision the study drug will be stopped however the subject will continue in the study After 2 hours if blood pressure is 95 systolic then give 1 more 5 mg of Tadalafil or placebo and monitor blood pressure for 2 hours If blood pressure is 95 then dismiss subject on 2 5 mg tabs of tadalafil or placebo If blood pressure is between 90 - 95 mmHg systolic then dismiss on 1 5 mg tab of Tadalafil or placebo
Patients will then be dismissed Subjects will also have access to a 24-hour phone number should they have any questions or develop any side effects Subjects will return after one week or - 4 days for electrolyte check They will also receive a weekly phone call to review status
At 2 weeks 5 days from dismissal if blood pressure is 100 than add 1 5 mg tab of Tadalafil or placebo to make a total of 3 5mg tabs of Tadalafil or placebo
At 4 weeks 5 days if blood pressure is 100 add 1 5 mg tab to make a total of 4 5 mg Tadalafil or placebo
After six weeks or - 5 days subjects will repeat blood draw for safety labs total blood count and electrolytes For patients who do not live more than 25 miles away we will try to arrange this visit with the patients local physician
At the end of the twelve-week study period or - 8 days subjects will be admitted to the Clinical Research Unit the afternoon prior to the renal clearance study Echocardiography renal clearance humoral determination and acute saline load will be performed in the same manner as the baseline study Subjects will also perform a 24-hour urine collection the day prior to their return visit for determination of sodium excretion and creatinine clearance Subjects will be dismissed after the renal clearance study
Prior to initiation of the study subjects will be stabilized for at least one week on a no added salt diet 120 milliequivalents of sodiumsalt per day mEq Naday which will be maintained throughout the study period
Subjects will be admitted to the Clinical Research Unit CRUon the evening before the active study day They will be able to order a no-added salt meal and will not have anything to eat after midnight until the last renal clearance blood draw the next day Bladder scan will be carried out to assess for urine retention On the active study day subjects take their medications upon awakening however diabetics will hold their diabetic medications until after the last renal clearance test then they will be able to order a regular diet meal and take their diabetic medications Subjects will be asked to drink 5mlKg milliliters per kilogram of body weight of water to insure sufficient urinary flow A priming dose calculated according to body size of Iothalamate to measure glomerular filtration rate GFR and para-amino-hippurate PAH to measure effective renal plasma flow ERPF is infused followed by a constant rate IV sustaining dose calculated according to estimated kidney function of Iothalamate or PAH The subjects will be asked to empty their bladder spontaneously every thirty minutes Throughout the study at the end of each 30-minute clearance period subjects will be asked to drink an amount of water equivalent to the sum of the blood losses and the urinary flow After an equilibration period of 45 minutes a 30-minute baseline renal clearance will be carried out
Blood pressure will be measured at 20-minute intervals by using automatic blood pressure cuff and heart rate will be continuously monitored by electrocardiography Echocardiography will be performed during these baseline clearances to determine left atrial LA and Left Ventricular LVvolumes and systolic and diastolic function
After the baseline clearance the acute saline load will be administered normal saline 09 025 mlkgmin for 1 hour During the 1 hour saline load one 30-minute clearance as outlined above will be repeated with the subjects in supine position after which a second 30-minute clearance will be repeated with the subject sitting or the head of the bed up As above blood samples are collected midway during each clearance and urine samples are obtained every 30 minutes Echocardiography will be repeated immediately after the end of the saline infusion
At the completion of the baseline renal clearance periods and response to acute sodium load subjects will be randomized to Tadalafil or placebo Subjects will be randomized in a 21 fashion
All subjects will take oral Tadalafil 5 mg or placebo once a day The blood pressure will be checked prior to administering the drugThereafter both blood pressure and heart rate will continue to be monitored for the next 4 hours If after the first dose of study drug if patients systolic blood pressure is 85 mmHg systolic and has symptoms of hypotension eg lightheadedness dizziness feeling faint blurred vision the study drug will be stopped however the subject will continue in the study After 2 hours if blood pressure is 95 systolic then give 1 more 5 mg of Tadalafil or placebo and monitor blood pressure for 2 hours If blood pressure is 95 then dismiss subject on 2 5 mg tabs of tadalafil or placebo If blood pressure is between 90 - 95 mmHg systolic then dismiss on 1 5 mg tab of Tadalafil or placebo
Patients will then be dismissed Subjects will also have access to a 24-hour phone number should they have any questions or develop any side effects Subjects will return after one week or - 4 days for electrolyte check They will also receive a weekly phone call to review status
At 2 weeks 5 days from dismissal if blood pressure is 100 than add 1 5 mg tab of Tadalafil or placebo to make a total of 3 5mg tabs of Tadalafil or placebo
At 4 weeks 5 days if blood pressure is 100 add 1 5 mg tab to make a total of 4 5 mg Tadalafil or placebo
After six weeks or - 5 days subjects will repeat blood draw for safety labs total blood count and electrolytes For patients who do not live more than 25 miles away we will try to arrange this visit with the patients local physician
At the end of the twelve-week study period or - 8 days subjects will be admitted to the Clinical Research Unit the afternoon prior to the renal clearance study Echocardiography renal clearance humoral determination and acute saline load will be performed in the same manner as the baseline study Subjects will also perform a 24-hour urine collection the day prior to their return visit for determination of sodium excretion and creatinine clearance Subjects will be dismissed after the renal clearance study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HL76611-07P3 | OTHER_GRANT | NIH | None |