Trial Outcomes & Findings for Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2) (NCT NCT01970176)

NCT ID: NCT01970176

Last Updated: 2021-06-11

Results Overview

Change in total urinary sodium excretion as measured by MEq/min

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline, 12 weeks
• Results posted on: 2021-06-11

Participant Flow

Participant milestones

Measure	Tadalafil Subject received Tadalafil daily for a total of 12 weeks Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) 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. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.	Placebo Subject received Placebo daily for a total of 12 weeks Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
Overall Study STARTED	14	6
Overall Study COMPLETED	14	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2)

Baseline characteristics by cohort

Measure	Tadalafil n=14 Participants Subject received Tadalafil daily for a total of 12 weeks Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) 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. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.	Placebo n=6 Participants Subject received Placebo daily for a total of 12 weeks Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.	Total n=20 Participants Total of all reporting groups
Age, Continuous	71 years n=93 Participants	64 years n=4 Participants	67 years n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	1 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants	6 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	6 participants n=4 Participants	20 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Change in total urinary sodium excretion as measured by MEq/min

Outcome measures

Measure	Tadalafil n=14 Participants Subject received Tadalafil daily for a total of 12 weeks Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) 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. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.	Placebo n=6 Participants Subject received Placebo daily for a total of 12 weeks Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
Change in Urinary Sodium Excretion	29.5 MEq/min Interval -4.2 to 77.2	25.1 MEq/min Interval 2.9 to 61.3

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Change in total GFR as measured by ml/1.72m2

Outcome measures

Measure	Tadalafil n=14 Participants Subject received Tadalafil daily for a total of 12 weeks Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) 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. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.	Placebo n=6 Participants Subject received Placebo daily for a total of 12 weeks Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
Change in Glomerular Filtration Rate (GFR)	-6.2 ml/1.72m2 Interval -30.0 to -1.5	4.5 ml/1.72m2 Interval -18.5 to 11.0

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Change in total urinary cGMP hormone excretion as measured by pmol/min

Outcome measures

Measure	Tadalafil n=14 Participants Subject received Tadalafil daily for a total of 12 weeks Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) 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. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.	Placebo n=6 Participants Subject received Placebo daily for a total of 12 weeks Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
Change in Urinary Cyclic Guanosine 3',5'-Monophosphate (cGMP) Hormone Excretion	-71.1 pmol/min Interval -266.0 to -41.0	51.6 pmol/min Interval -198.0 to 237.0

Adverse Events

Tadalafil

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tadalafil n=14 participants at risk Subject received Tadalafil daily for a total of 12 weeks Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) 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. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.	Placebo n=6 participants at risk Subject received Placebo daily for a total of 12 weeks Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
Gastrointestinal disorders Indigestion	14.3% 2/14 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.	0.00% 0/6 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/14 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
Gastrointestinal disorders Diarrhea	21.4% 3/14 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.	0.00% 0/6 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.	0.00% 0/6 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
Musculoskeletal and connective tissue disorders Back Pain	7.1% 1/14 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.	0.00% 0/6 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
Nervous system disorders Syncope	7.1% 1/14 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.	0.00% 0/6 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.

Additional Information

Horng H. Chen, M.D.

Mayo Clinic

Phone: 507-284-8896

Email: chen.horng@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place